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  • Subunit-Based Intraflap Debulking Technique for Secondary Contouring After Free Flap Reconstruction

    Authors: Yoo K-E, Lee K-T Affiliation: Samsung Med Center, Sungkyunkwan School of Medicine, Seoul, Korea Journal: Microsurgery, 2026 PMID: 42231540 Key takeaways Intraflap incisions placed along anatomic subunit boundaries allow direct access to central flap bulk while limiting unnecessary peripheral dissection. In 22 selected cases, there were no wound-healing complications, infections, hematomas, seromas, or reoperations. Most patients were successfully treated through a single intraflap incision, although 6 required addition debulking procedures. Background Secondary debulking is frequently needed when a free flap remains thicker than adjacent native tissue. Conventional margin-based approaches can require dissection through already-thin peripheral flap tissue to reach central fullness, particularly near the original pedicle. Objective Evaluate the safety and clinical utility of a subunit-based intraflap debulking technique in which incisions are placed across the flap along natural anatomic boundaries to directly address central bulk. Methods Design: Retrospective, single-center case series using a prospectively maintained database. Study period: December 2021 to August 2025. Population: 22 patients with free flaps spanning multiple anatomic subunits who subsequently underwent intraflap secondary debulking. Mean age: 59 years. Mean BMI: 25.1 kg/m². Anatomic distribution: Lower extremity: 10 Upper extremity: 8, including 7 finger and 1 arm Head and neck: 4, including 2 nose and 2 lip Muscle flaps with skin grafts and pedicled flaps were excluded. Debulking was performed at least 3 months after the index reconstruction, at a median of 10 months (range, 3 to 39 months). Incisions were designed along anatomic subunit borders. Redundant skin and underlying fat were excised in a cone-shaped fashion, with additional direct defatting as needed. The pedicle was not actively sought or preserved during revision. Primary outcomes were wound dehiscence, delayed healing, seroma, hematoma, infection, and reoperation. No power calculation or comparative statistical analysis was reported. Results Zero patients developed wound dehiscence, delayed healing, seroma, hematoma, infection, or required reoperation. Median time to total suture removal was 14 days (range, 7 to 23 days). Most cases were treated through a single intraflap incision. 6/22 patients required more than one debulking procedure, using separate incisions along different subunit boundaries. All patients reported satisfaction with the aesthetic result, although no validated patient-reported outcome instrument was used. In the facial examples, debulking along natural boundaries such as the nasolabial fold restored contour while positioning the final scar within an existing anatomic transition. Conclusion The authors conclude that subunit-based intraflap debulking performed more than 3 months after free flap reconstruction may be a safe and effective secondary contouring option in selected patients. The approach provides direct access to central bulk while helping restore natural anatomic boundaries. Strengths Simple, technically intuitive solution to the difficult problem of central flap bulk. Uses the revision scar constructively by placing it along a natural anatomic boundary. Complete absence of wound-healing complications is reassuring regarding the principal safety concern. Limitations Small, retrospective, uncontrolled, single-surgeon series. No objective contour measurements, blinded aesthetic assessment, or validated satisfaction instrument. Outcomes were not analyzed by anatomic region. Only one patient had radiotherapy at the flap site, so the effect of radiation on healing and contouring outcomes could not be meaningfully assessed. Clinical relevance The practical value of this technique is that it allows the surgeon to address central bulk directly while placing the resulting scar where a natural boundary should exist. This is especially attractive in reconstruction of areas where contour transitions matter as much as thickness, including the nose, lip, hand, foot, and ankle. Editorial notes This is a clever and interesting technical paper. The most important contribution is not simply another way to remove fat from a flap, but a different way of thinking about secondary contouring: use the anatomic subunit boundary as both the access point and the final scar. The series supports that this can be done safely in mature free flaps, even without deliberately identifying or preserving the original pedicle. What it does not establish is whether 3 months is the optimal timing, whether vascular independence from the pedicle can be assumed in every flap, or whether this approach is superior to margin-based debulking or liposuction. Given the potential consequence of flap ischemia, even a very low incidence of perfusion-complications could be enough to discourage widespread adoption. A 22-patient series with no complications is reassuring, but it cannot define that risk. The facial examples are particularly instructive because they demonstrate the broader reconstructive principle. Good secondary contouring is not simply about making a flap thinner. It is about restoring the normal creases, transitions, convexities, and boundaries that define the reconstructed region.

  • Jaw-in-a-day (JIAD) for malignant indications: A systematic review

    Authors: Trac J, Ramchandani R, Dutta P, Sarkis L, Calvisi R, Villemure-Poliquin N, Davies J, Somogyi-Ganss E, Blanas N, Cuddy K, Enepekides D, Higgins K, Philteos J, Eskander A Affiliation: University of Toronto-led collaboration including Sunnybrook Health Sciences Centre, Sinai Health, Michael Garron Hospital, University of Ottawa, Queen's University, and University of Sydney Journal: Oral Oncology PMID: 41422685 Key takeaways This is a review of true JIAD with same-day interim prosthetic rehabilitation, not a review of all immediate dental implant placement. The review excluded staged dental rehabilitation protocols in which dental implants were placed during the initial fibula reconstruction but the dental prosthesis was attached later. In other words, immediate implant placement alone did not qualify as JIAD; the prosthesis also had to be placed the same day. Planned same-day implant-supported prosthetic rehabilitation was achieved in 52/57 patients (91.2%), but prosthesis survival was 25/32 (78.1%) where reported. All 99 irradiated implants showed early osseointegration, yet 11/99 (11.1%) later failed; osteoradionecrosis was the major late concern. Background Jaw-in-a-day (JIAD) combines oncologic resection, fibular free flap reconstruction, dental implant placement, and immediate interim dental rehabilitation in one operation. This definition is important because several oncologic centers use immediate implant placement but intentionally delay vestibuloplasty and prosthetic loading. Objective Review published outcomes of JIAD for malignant maxillary or mandibular head and neck tumors. Methods Design: PRISMA systematic review using a predefined PROSPERO protocol (CRD420251043510). Search: MEDLINE, Embase, CENTRAL, Web of Science, and CINAHL from January 2013 through October 1, 2025. Eligibility: Patients of any age with maxillary or mandibular head and neck cancer treated with JIAD. Cohort studies, case series, and case reports were eligible. Critical intervention definition: JIAD required an interim prosthesis applied to the dental implants at completion of the ablative and reconstructive operation. Staged reconstruction, including the Rohner method, was excluded. Evidence base: 9 studies, 57 patients; 7/9 were retrospective and 3 were case reports. Pooled age and sex were not reported. Reconstruction: All 57 patients received fibular free flaps; all studies used virtual surgical planning. The mandible was the most common site (31/57), and squamous cell carcinoma was the most common pathology (37/57). Outcomes: Prosthesis placement, final prosthesis, survival, removal, implant failure, peri-implant complications, postoperative complications, and timing of adjuvant radiotherapy. Analysis: Descriptive statistics only. MINORS scores were 9-12/16 for non-case-report studies and 5 for case reports. Results Interim prosthesis: 52/57 patients (91.2%) received the planned prosthesis on the day of surgery. Prosthesis survival: Reported in 6 studies, with 25/32 prostheses surviving (78.1%) over follow-up ranging from 5 to 52 months. Irradiated implants: All 99 implants in a radiotherapy field demonstrated early osseointegration. Delayed loss occurred in 11/99 implants (11.1%) across 4/36 irradiated patients. Osteoradionecrosis: Six prostheses were removed because of ORN. Among patients receiving adjuvant therapy, the authors calculated ORN in 6/36 (16.7%). Other complications: Three cases of peri-implant mucositis resolved with local treatment. Where reported, cohort-level ORN rates were 15.4-25% and infection rates were 20-30.8%. Radiation timing: Two studies reported median time to radiotherapy or chemoradiotherapy of 44 and 57 days. Radiation dosimetry and whether ORN involved native versus transplanted bone were not reported. Conclusion The authors conclude that JIAD can provide high early implant and prosthetic success in carefully selected oncologic patients, but adjuvant radiation may increase ORN-associated late implant and prosthesis failure. Cancer stage and anticipated need for postoperative radiotherapy should inform patient selection. Strengths Predefined protocol, PRISMA reporting, broad multi-database search, independent screening and extraction, and formal risk-of-bias assessment. Separates early osseointegration from delayed implant loss and reports clinically meaningful prosthesis outcomes. Limitations Only 57 patients across 9 small studies, including 3 case reports, with substantial selection and publication bias. Follow-up was usually under 24 months, likely underestimating late radiation-related failure. The review excluded staged dental rehabilitation protocols in which implants were placed during the initial fibula reconstruction but the dental prosthesis was attached later. Therefore, its ORN and prosthesis-failure findings should not be generalized to all immediate dental implant protocols. Outcomes were inconsistently stratified by radiation exposure, preventing valid JIAD versus non-JIAD or irradiated versus nonirradiated comparisons. Clinical relevance JIAD appears technically feasible and can deliver immediate dental rehabilitation, but this review addresses the narrow strategy of same-day prosthetic loading. It does not establish that immediate implant placement itself is unsafe in cancer patients, because staged immediate-implant protocols were excluded. For reconstructive surgeons, the key clinical question may be timing of prosthetic loading rather than timing of implant placement alone. Editorial notes The central interpretive issue is what counted as JIAD. Patients only qualified if the dental prosthesis was attached during the same operation as tumor resection, fibula reconstruction, and implant placement. The review excluded staged protocols in which the implants were placed during the initial reconstruction but the teeth were attached later. Memorial Sloan Kettering's immediate dental implant placement (IDIP) workflow places implants at the index fibula reconstruction, then performs vestibuloplasty and implant exposure about 4-6 weeks later, with prosthetic loading shortly thereafter. In Allen et al. (PRS 2020; PMID 33234971), 27 IDIP patients received 72 implants; mean time to prosthetic loading was 55.6 days, 78% completed dental restoration within 1 year, and adjuvant radiotherapy was not delayed. A companion MSK pilot study found no adverse effect of immediate implants on postoperative complications or radiation dosimetry (Sandoval et al., 2020; PMID 31777154). More recent MSK long-term data further separate immediate implant placement from same-day JIAD: among 148 oncologic mandible reconstructions, 86 IDIP patients received 219 implants and were more likely to achieve dental rehabilitation than non-IDIP patients (69.8% vs 25.8%), with earlier rehabilitation (median 120 vs 355 days); adjuvant radiation was not associated with failure to complete rehabilitation (Allen et al., J Reconstr Microsurg 2026; PMID 40681154). A broader systematic review/meta-analysis of vascularized bone flaps reported 97.0% survival for immediately placed implants versus 89.9% for delayed implants, while confirming that radiation itself adversely affects implant survival (Panchal et al., PRS 2020; PMID 32459736). These studies do not prove that staged IDIP is superior to true JIAD, because the populations, loading strategies, and outcome definitions differ. They do show that the present review cannot answer the broader question of whether implants should be placed at the time of oncologic fibula reconstruction. A clinically useful next study would directly compare same-day JIAD with immediate implant placement plus delayed loading, using standardized radiation dosimetry, ORN definitions, implant/prosthesis survival, functional outcomes, and long-term follow-up.

  • Two-Stage Prepectoral Breast Reconstruction with and without Acellular Dermal Matrix: A Cluster-Randomized Noninferiority Trial

    Authors: Nelson JA, Shammas RL, Boe LA, Gönen M, Poulton RT, Stern CS, Rochlin DH, McCarthy CM, Allen RJ Jr, Coriddi M, Disa JJ, Mehrara BJ, Matros E Affiliation: Memorial Sloan Kettering Cancer Center, New York, NY Journal: Plastic and Reconstructive Surgery, March 2026 PMID: 41811168 Key takeaways ADM and no-ADM prepectoral tissue-expander reconstruction had nearly identical 90-day major complication rates: 13.2% vs 13.1%. ADM met the prespecified noninferiority criterion; the one-sided 95% upper confidence limit for excess major complications was 6.2%, below the 7% margin. Infection, reoperation, explantation, BREAST-Q physical well-being, and pain were not significantly different; seroma trended lower with ADM (20.0% vs 27.4%, p=0.056). The trial establishes short-term safety of ADM, not a demonstrated benefit or necessity; long-term contracture, rippling, malposition, aesthetics, and cost were not resolved. Background Acellular dermal matrix (ADM) is commonly used in prepectoral implant reconstruction for support and implant coverage, but it adds cost and has been linked to infection and seroma. High-level evidence directly comparing ADM with no ADM in the prepectoral plane has been limited. Objective Determine whether immediate two-stage prepectoral reconstruction with ADM is noninferior to reconstruction without ADM for major complications within 90 days of tissue-expander placement. Methods Design: Prospective, single-center, randomized noninferiority trial at Memorial Sloan Kettering Cancer Center. The first 35 patients were individually randomized; after a November 2022 amendment, 333 were cluster-randomized by calendar month. Blinding was not feasible. Level of evidence was not stated in the manuscript. Population: 368 women, 623 breasts; median age 44 years, BMI 24.4 kg/m². Mastectomies: 69.3% bilateral, 91.0% therapeutic. Eligible patients were age 21–75 with adequate mastectomy-flap perfusion and a viable prepectoral plane. Current smoking, non-English fluency, prior sternotomy, and direct-to-implant reconstruction were excluded. Intervention: Smooth prepectoral tissue expander with anterior perforated ADM versus the same expander secured by tabs without ADM. Skin-flap perfusion was assessed with SPY. Primary endpoint: Breast-level occurrence of ≥1 major complication within 90 days—infection, unplanned reoperation under general anesthesia, or expander explantation. Secondary endpoints included clinically significant seroma, BREAST-Q Physical Well-being of the Chest, and postoperative pain. Statistics: Prespecified 7% noninferiority margin; planned 320 patients (~480 breasts) for ≥85% power at one-sided α=0.025. Primary analysis was intention-to-treat with adjustment for clustering within bilateral patients; as-treated and per-protocol sensitivity analyses were also performed. Results Primary outcome- Major complications within 90 days: 39/295 breasts (13.2%) with ADM vs 43/328 (13.1%) without ADM; absolute difference 0.11%. The one-sided 95% upper limit was 6.2%, meeting noninferiority. Sensitivity analyses were concordant: as-treated 12.7% vs 13.5% (upper limit 5.2%); per-protocol 12.7% vs 13.1% (upper limit 5.8%). Individual events: infection 9.2% vs 11.6% (p=0.4); reoperation 2.7% vs 1.5% (p=0.4); explantation 7.5% vs 5.2% (p=0.3); seroma 20.0% vs 27.4% (p=0.056). BREAST-Q physical well-being was similar at baseline (median 92 both groups), 30 days (60 vs 55; p=0.2), and 90 days (76 vs 76; p=0.3). Pain trajectories were also similar. Conclusion The authors conclude that ADM-assisted two-stage prepectoral reconstruction is noninferior to no ADM for 90-day major complications, with comparable minor complications, physical well-being, and pain. They emphasize that longer follow-up is needed to determine whether ADM provides meaningful long-term clinical benefits. Strengths Prospective randomized design with a prespecified noninferiority margin, power calculation, intention-to-treat analysis, and concordant sensitivity analyses. Large breast-level cohort with standardized prepectoral technique and objective skin-flap perfusion assessment. Limitations Single-center, unblinded study in a relatively healthy, nonsmoking population; generalizability to higher-risk patients and other practice settings is uncertain. Note: avg. BMI of 24.4 Most enrollment used month-level cluster randomization, with treatment known in advance to surgeons and staff; this introduces potential selection and temporal-practice bias despite similar measured baseline characteristics. Protocol crossover occurred, although sensitivity analyses were consistent. The 7% noninferiority margin could still permit a clinically meaningful excess complication rate. Follow-up stops at 90 days after expander placement. The study does not establish benefit for capsular contracture, rippling, implant malposition/bottoming out, aesthetic outcome, or cost. Clinical relevance For surgeons already using ADM, these data are reassuring that ADM does not appear to impose a major short-term complication penalty within the trial’s 7% margin. For surgeons omitting ADM, the nearly identical observed outcomes provide no short-term evidence that routine ADM is necessary; the choice should remain driven by longer-term reconstructive goals and cost until later follow-up is available. This study is limited by its 90 day follow up; Practice-changing evidence will come from the planned post-exchange follow-up, ideally incorporating aesthetic assessment, revision burden, capsular contracture, rippling, and formal cost-effectiveness.

  • LYMPHA Technique to Prevent Arm Lymphedema After Breast Cancer Treatment: 15-Year Follow-Up

    Authors: Boccardo F, Santori G, Fedre B, Fregatti P, De Paoli F, Murelli F, Dessalvi S, De Cian F Affiliation: University of Genoa and San Martino Polyclinic Hospital, Genoa, Italy Journal: Annals of Surgical Oncology, July 2026 PMID: 41886031 Key takeaways At up to 15 years, arm lymphedema occurred in 6/270 (2.2%) patients undergoing ALND with LYMPHA versus 95/230 (41.3%) without LYMPHA. The apparent benefit persisted despite radiotherapy: lymphedema developed in 2.5% with LYMPHA plus radiation versus 45% without LYMPHA plus radiation. Most lymphedema presented within 24 months, and no new cases occurred after 36 months in this cohort. The magnitude and durability of effect are striking, but the study is retrospective and nonrandomized, so causal certainty remains limited. Background Axillary lymph node dissection (ALND) remains necessary for selected breast cancer patients and carries a substantial lifelong risk of breast cancer-related lymphedema. LYMPHA, an immediate lymphatic reconstruction technique, attempts to restore arm lymphatic drainage at the time of ALND. Objective Assess the long-term effectiveness of LYMPHA for primary prevention of arm lymphedema after ALND, with follow-up extending to 15 years. Methods Design: Retrospective, single-center observational cohort. Population: 550 consecutive Caucasian women undergoing ALND from January 2008 through July 2009; 500 completed long-term follow-up and were analyzed. Groups: 270 underwent ALND plus LYMPHA; 230 underwent ALND without preventive microsurgery. Radiotherapy exposure was identical at 75.2% in each group. Selection: LYMPHA use was determined preoperatively by microsurgical team availability, organizational factors, and patient preference. Three attempted LYMPHA cases without suitable lymphatics were excluded. Technique: Dual tracer mapping with blue dye and indocyanine green achieved 99% lymphatic identification. Two to four brachial lymphatics were anastomosed to a preserved collateral axillary venous branch using a sleeve technique under 15x to 20x microscopy. Outcomes: Lymphedema was defined as at least 5% excess arm volume versus the contralateral arm or tissue dielectric constant ratio at least 1.4. Assessments were every 6 months for 2 years, then annually. Statistics: Mann-Whitney U, chi-square, Kaplan-Meier analysis, and log-rank testing; two-tailed alpha 0.05. No power calculation or multivariable adjustment was reported. Results Overall lymphedema: 6/270 (2.2%) with LYMPHA versus 95/230 (41.3%) without LYMPHA. With radiotherapy: 5/203 (2.5%) with LYMPHA versus 78/173 (45%) without LYMPHA. Without radiotherapy: 1/67 (1.5%) with LYMPHA versus 17/57 (30%) without LYMPHA. 15-year lymphedema-free cumulative probability: 0.978 with LYMPHA versus 0.587 without LYMPHA, p < 0.001. Lymphedema onset ranged from 6 to 36 months, with most cases in the first 24 months. All affected patients required long-term conservative therapy. Axillary web syndrome occurred in 5 (2%) LYMPHA patients versus 97 (42%) controls. Baseline age, BMI, arm volume, TDC ratio, radiation, number of nodes removed, nodal burden, chemotherapy, and breast surgery type were similar between groups. Conclusion The authors conclude that LYMPHA is an effective method for primary prevention of secondary arm lymphedema after ALND, with a preventive effect that appears durable through long-term follow-up. Strengths Exceptionally long follow-up, with mean follow-up of 13.2 years and assessment out to 15 years. Large cohort with standardized serial arm volumetry and tissue dielectric constant measurements by trained lymphedema therapists. Balanced major treatment-related lymphedema risk factors between groups, including radiotherapy, nodal burden, chemotherapy, and breast surgery type. Detailed technical description from the group that originally developed LYMPHA. Limitations Retrospective, nonrandomized design with potential selection and center-expertise bias; treatment depended partly on team availability and patient preference. Fifty of 550 patients were lost to or lacked complete long-term follow-up. No multivariable model, propensity adjustment, or randomized comparison was used to address residual confounding. The paper contains a reporting inconsistency on page 6, stating that the groups 'did not differ significantly' in 15-year volume/TDC changes while also reporting p < 0.01. Generalizability to lower-volume programs is uncertain because the procedure used dual tracers, dedicated lymphatic microsurgeons, operative microscopy, and an acknowledged learning curve. Clinical relevance For patients who truly require ALND, this study provides unusually long-term support for immediate lymphatic reconstruction. The effect size is clinically large and remains apparent in irradiated patients, making LYMPHA highly relevant when microsurgical expertise and coordinated axillary planning are available. Editorial notes This is one of the most important long-term datasets supporting immediate lymphatic reconstruction. The headline result is difficult to ignore: lymphedema occurred in 2.2% with LYMPHA versus 41.3% without it, an absolute difference of about 39 percentage points. That translates to an approximate number needed to treat of 3, although this is a simple calculation from an observational study and should not be interpreted as randomized efficacy. The strongest message is durability. The Kaplan-Meier curves separate early and remain essentially flat after 3 years, suggesting that successful immediate reconstruction may alter the long-term trajectory of lymphatic failure rather than merely delay its presentation. The major caveat is causal inference. This is not a randomized comparison, and the procedure was performed by a highly specialized team using dual mapping, microscope-based anastomosis, and 2 to 4 lymphatic channels. The enormous difference between groups may reflect a true biologic effect, but the study design cannot fully exclude selection, surveillance, or expertise effects. I would view these data as compelling support for offering immediate lymphatic reconstruction during ALND at experienced centers, while recognizing that reproducibility depends heavily on technique and team execution.

  • Reconstruction for Salvage Laryngectomy With Limited Pharyngectomy

    Authors: Moreno MA, Wax MK, Gardner JR, Cannady SB, Graboyes EM, Bewley AF, Dziegielewski PT, Khaja SF, Bayon R, Ryan J, Al-Khudari S, El-Deiry MW, Ghanem TA, Huang A, Patel R, Higgins KM, Jackson RS, Patel UA Affiliation: 17 academic tertiary head and neck centers in the United States and Canada, led by University of Arkansas for Medical Sciences. Journal: JAMA Otolaryngology-Head & Neck Surgery, June 2024 PMID: 38635282 Key Takeaways In salvage laryngectomy defects amenable to primary closure, free tissue transfer (FTT) had the lowest pharyngocutaneous fistula (PCF) rate: 22.4% vs 34.5% with primary closure (PC) and 39.1% with regional closure (RC). Adjusted PCF risk was about twice as high with PC or RC versus FTT; estimated number needed to treat with FTT was 7. The key signal may be cutaneous interposition (skin paddle sewn into the suture line) rather than free flap reconstruction itself. Pectoralis myocutaneous cutaneous-paddle interposition was not associated with higher PCF risk than interpositional FTT. Closure technique was not associated with clinically meaningful differences in 1- or 2-year functional outcomes. Background Previously irradiated salvage laryngectomy carries substantial PCF risk. Many institutions have begun adopting FTT for these defects, but there is not strong evidence to support this change. Objective Assess the association of pharyngeal closure technique with perioperative complications and long-term function after salvage laryngectomy with no or limited pharyngectomy. Methods Retrospective cohort from 17 academic centers, 2011-2016; 309 patients, minimum 1-year follow-up. Mean age 64.7 years; 82.8% male; 57.1% had prior chemoradiotherapy. Inclusion criteria: salvage laryngectomy performed for oncologic indication or laryngeal dysfunction, completion of full course of radiation or chemoradiation, no associated pharyngectomy defect that would allow for tension-free PC. Exclusions: Extended pharyngectomy, >1 cm tongue-base extension, skin involvement, reirradiation, uncertain defect extent, and salivary bypass tube use Reconstruction: FTT 161 (52.1%), RC 64 (20.7%), PC 84 (27.2%). FTT was mainly radial forearm (79) or anterolateral thigh (73); RC included pectoralis myofascial onlay and cutaneous interposition. Outcomes included PCF rate, 30-day reoperation, need for delayed reconstruction, dilation, diet, gastrostomy use, and communication. Multivariable generalized estimating equations adjusted for smoking, chemoradiotherapy, pharyngectomy, and neck dissection. Formal power and alpha were not reported. Results Overall PCF rate: 90/309 (29.1%), 13.3% subclinical (detected on routine videofluoroscopy). All but one subclinical fistula occurred in patient closed by PC + pectoralis onlay PCF rate: Free Tissue (FTT) 36/161 (22.4%) Regional Closure (RC) 25/64 (39.1%) Primary Closure (PC) 29/84 (34.5%). Adjusted PCF risk vs FTT: PC RR 2.2 (95% CI, 1.1-4.4); RC RR 2.5 (1.3-4.8). FTT vs no FTT: RR 0.6 (0.4-0.9), NNT 7. Skin-paddle interposition reduced PCF risk (RR 0.7, 95% CI, 0.5-0.9). Versus interpositional FTT, PC and pectoralis myofascial onlay had higher PCF risk; pectoralis myocutaneous interposition did not. Thirty-day reoperation was 13.6%; 9.4% required delayed pharyngeal reconstruction. These did not differ between groups Among 249 patients without disease at 1 year, closure technique was not associated with dilation, diet, gastrostomy use, or communication strategy. Conclusion For salvage laryngectomy defects amenable to primary closure, pharyngeal cutaneous interposition, most commonly with FTT, was associated with lower PCF risk. Closure technique had no measurable association with longer-term swallowing outcomes. Strengths Large multicenter cohort focused on the clinically important "could close primarily" salvage defect. Center clustering and established PCF risk factors were incorporated into adjusted analysis. Distinguishes muscle-only onlay from true cutaneous interposition. Limitations Retrospective, nonrandomized design with surgeon and center selection bias. FTT patients had more chemoradiotherapy, pharyngectomy, and neck dissection at baseline. Comorbidity severity was incompletely captured. Functional endpoints were coarse; patients with disease at 1 year were excluded from long-term analysis. Clinical relevance For a previously irradiated salvage laryngectomy that can technically be closed primarily, these data favor vascularized cutaneous interposition, whether with free flap or myocutaneous pectoralis flap, over primary closure or pectoralis myofascial onlay. They do not prove that a free flap is mandatory if a reliable regional flap can provide true cutaneous interposition.

  • Radiation and Reconstructive Failure: Long-Term Outcomes in Two-Stage Flap Versus Implant Breast Reconstruction

    Authors: Shammas RL, Wang J, Boe LA, Levy J, Graziano FD, Allen RJ Jr, Cordeiro PG, Disa JJ, Mehrara BJ, Nelson JA Affiliation: Memorial Sloan Kettering Cancer Center, New York, NY Journal: Annals of Surgical Oncology, March 2026 PMID: 41191309 Key takeaways In radiated patients, those who underwent implant reconstruction had substantially greater predicted chance of reconstructive failure than flap reconstruction: 12% vs 1.4% at 72 months. Implant reconstruction was associated with a 7.57-fold higher adjusted hazard of failure compared with flap reconstruction. Three-year BREAST-Q satisfaction with breasts favored flap reconstruction by 8 points, exceeding the 4-point minimal clinically important difference used in the study.. All patients began with the same initial tissue-expander stage, during which 5.4% of the overall cohort experienced reconstructive failure before definitive implant or flap reconstruction. Background Radiation increases complications after breast reconstruction, particularly with prosthetic reconstruction. Long-term comparative data on reconstructive failure and patient-reported outcomes after a tissue-expander-first strategy followed by either implant or flap reconstruction remain limited. Objective Compare long-term reconstructive failure and patient-reported outcomes between two-stage implant and flap reconstruction in patients receiving radiation therapy. Methods Design: Single-institution retrospective cohort study at Memorial Sloan Kettering Cancer Center, 2017 to 2023. Population: 1,210 patients receiving immediate tissue-expander (TE) placement and radiation. Median age: 48 years Median BMI: 23.7 kg/m² Bilateral reconstruction: 57% Radiation after TE placement: 90% Median follow-up: 49.8 months Definitive reconstruction: Of 1,210 patients undergoing TE placement, 930 proceeded to implant reconstruction and 215 to flap reconstruction; 65 experienced TE-stage failure. Exclusions: Immediate flap, direct-to-implant reconstruction, delayed TE placement, mixed/hybrid bilateral reconstruction, and pedicled flap reconstruction. Primary endpoint: Time to reconstructive failure, defined as TE or implant loss without replacement, total flap loss, or implant-to-flap conversion because of significant pain, capsular contracture, or aesthetic dissatisfaction. Secondary endpoints: Surgical complications and BREAST-Q patient-reported outcomes. Statistics: Wilcoxon rank sum test for continuous variables; Chi-squared or Fisher’s exact test for categorical variables; Kaplan-Meier curves to estimate cumulative incidence of long-term reconstructive failure; log-rank test to compare groups; multivariable Cox proportional hazards regression to evaluate association between reconstruction type and reconstructive failure; multivariable-adjusted linear mixed effects model for longitudinal BREAST-Q analysis. Statistical significance was P < 0.05. Results Overall reconstructive failure: 157/1,210 patients (13%). TE stage: 65/1,210 (5.4%) Flap stage: 3/215 (1.4%) Implant stage: 89/930 (9.6%) Among implant failures, 51 (5.5%) patients had the implant removed without replacement and 38 (4.1%) converted to flap reconstruction. Most common complications across the entire reconstructive course were infection (15%), seroma (9.7%), hematoma (3.8%), and prosthetic exposure (3.8%). Most common contributing factors among patients who experienced reconstructive failure were infection (34.4%), prosthetic exposure (31.8%), capsular contracture (11.5%), aesthetic dissatisfaction (9.6%), and chronic implant-related pain (9.6%). Estimated 72-month failure: 12% for implant reconstruction versus 1.4% for flap reconstruction (log-rank p= 0.003). After multivariable adjustment, implant reconstruction was associated with markedly increased failure versus flap reconstruction: HR 7.57 (95% CI 2.36-24.2; p< 0.001). Infection independently increased failure risk: HR 2.61 (95% CI 1.58-4.31; p < 0.001). BREAST-Q satisfaction with breasts at 3 years: flap 65 vs implant 57 (P = 0.014), an 8-point difference exceeding the 4-point minimal clinically important difference; after adjusting for covariates, still favored flap reconstruction for satisfaction with breasts (β = -6.5 for implant vs flap; 95% CI -9.4 to -3.6; p < 0.001). BREAST-Q physical well-being of chest at 3 years: flap 68 vs implant 76 (P=0.035); however, after adjusting for covariates, no significant differences noted (β = 0.48 for implant vs flap; 95% CI -2.4 to 3.3; p = 0.7). Conclusion Among patients undergoing radiation and an initial tissue-expander reconstruction, definitive implant reconstruction was associated with higher predicted long-term reconstructive failure and lower breast satisfaction than definitive flap reconstruction. The authors emphasize counseling radiated patients about these long-term risks when choosing definitive reconstruction. Strengths Includes a large cohort of more than 1,200 radiated patients undergoing immediate two-stage reconstruction. Captures reconstructive failures and outcomes over an extended period (median follow-up 49.8 months), with cumulative failure estimates reported through 72 months. Directly compares outcomes among patients who all began with the same tissue-expander (TE) stage before diverging to definitive implant or flap reconstruction. Includes validated BREAST-Q outcomes and clinically meaningful longitudinal failure data. Limitations Single-center, retrospective, nonrandomized study, creating important potential for selection bias and residual confounding. Definitive reconstruction was selected after radiation based partly on evolving clinical factors and patient preferences, so the implant and flap groups were not exchangeable at baseline. Cohorts differed significantly in BMI, race, chemotherapy timing, reconstructive laterality, radiation timing, and TE pocket plane despite multivariable adjustment. Although analyses adjusted for confounding variables, unmeasured factors such as variations in radiation technique could have influenced outcomes. BREAST-Q questions about the natural appearance of a breast may be less generalizable to implant than autologous reconstruction. Factors that may influence satisfaction, including fat grafting, nipple reconstruction, and psychological diagnoses, were not uniformly available and therefore were not included in the multivariable models. The study was underpowered to definitively state differences in long-term BREAST-Q scores. Follow-up did not extend beyond 72 months. Lack of nuanced examination of radiation timing relative to implant exchange. Clinical relevance For patients who require radiation and are candidates for either approach, these findings strengthen counseling in favor of autologous reconstruction when minimizing long-term reconstructive failure and maximizing breast satisfaction are priorities. The increased risk of failure with implant reconstruction extends beyond the perioperative period and persists throughout the long-term reconstructive course. Importantly, not every patient is a candidate for or desires autologous reconstruction; therefore, these findings are most useful for individualized reconstructive planning and counseling regarding the long-term risks and expected patient-reported outcomes of each approach. Editorial notes This study quantifies the long-term impact of radiation on implant reconstruction: failure continued to rise to approximately 12% at 6 years, compared with 1.4% for flap reconstruction. However, the adjusted HR of 7.57 should not be interpreted causally. Reconstruction type was selected after radiation based on clinical factors and patient preference, creating potential confounding by indication. Patients with more substantial radiation-related tissue changes may have been considered poor implant candidates and preferentially directed toward flap reconstruction, potentially underestimating the full adverse effect of radiation on implant-based reconstruction. The failure definition also favored detection of problems in the implant group because elective implant-to-flap conversion counted as failure, with no directly comparable endpoint for flaps. The key practical finding is the absolute difference in failure and satisfaction: approximately 12% versus 1.4% failure at 6 years and an 8-point BREAST-Q advantage for flaps. These results support discussing autologous reconstruction with suitable radiated patients but do not establish that flaps are preferable for everyone or that the findings will generalize beyond high-volume microsurgical centers.

  • Incisional negative pressure wound therapy for prevention of surgical site infection

    Authors: Patel S, Nischal SA, Kale KM, Dubb A, Prasad SK, Refai D Affiliation: Thomas Jefferson University Hospital; University of Oxford; Emory University Hospital Midtown Journal: JAMA Surgery, August 2026 PMID: 42616534 Key takeaways Incisional negative pressure wound therapy (iNPWT) reduced overall SSI from 14.4% to 9.6% (RR 0.64); NNT 21. Benefit extended to superficial and deep SSI, wound dehiscence, seroma, skin necrosis, and reoperation, but not organ-space SSI. iNPWT substantially increased skin blistering/reaction (RR 4.51; NNH 18) and device-related adverse events (RR 11.87; NNH 11). Evidence for SSI reduction appears mature, but benefit is not uniform across surgical populations; the authors favor selective rather than routine use. Only 4.2% of patients were in breast or plastic surgery, limiting reconstruction-specific conclusions. Background iNPWT is increasingly used prophylactically on primarily closed incisions as a nonantibiotic strategy to reduce surgical site infection (SSI). Prior studies have suggested benefit but differ substantially in surgical population, device, wound class, and reported harms. Objective Evaluate the efficacy and safety of iNPWT compared with standard dressings in adults undergoing surgery, including effects on SSI subtypes and wound/device complications. Methods Design: Systematic review and random-effects meta-analysis of randomized clinical trials; prospectively registered with PROSPERO and conducted according to PRISMA/Cochrane guidance. Search: PubMed, Embase, and CENTRAL through March 7, 2026. Studies/patients: 85 RCTs; 16,980 patients; 8,463 iNPWT and 8,517 standard dressing. Population: Mean age 48.3 years; mean BMI approximately 31; 16% had diabetes. Most procedures were obstetric/gynecologic (33.5%) or abdominal (29.9%); breast surgery represented 2.7% and plastic surgery 1.4%. Primary endpoint: Overall SSI. Secondary endpoints: Deep, superficial, and organ-space SSI; dehiscence, seroma, necrosis, reoperation, readmission, mortality, blistering, and device-related adverse events. Statistics: Random-effects models using restricted maximum likelihood; risk ratios with 95% CIs; heterogeneity assessed with I². Sensitivity, leave-one-out, publication-bias, and trial sequential analyses were performed. Trial sequential analysis used α=0.05 and 90% power. Evidence assessment: Cochrane RoB 2 and GRADE; overall certainty was moderate. Results Overall SSI: 800/8,338 (9.6%) vs 1,207/8,407 (14.4%); RR 0.64 (95% CI 0.57–0.72), p<0.001; NNT 21. Deep SSI: RR 0.66 (95% CI 0.51–0.86); NNT 74. Superficial SSI: RR 0.59 (95% CI 0.49–0.72); NNT 25. Organ-space SSI: No significant reduction; RR 0.90 (95% CI 0.67–1.20). iNPWT also reduced dehiscence (RR 0.73), seroma (RR 0.77), skin necrosis (RR 0.38), and reoperation (RR 0.80). No significant differences occurred in readmission, mortality, pain, serious adverse events, cellulitis, or wound bleeding. Skin blistering/reaction: RR 4.51 (95% CI 2.37–8.58); NNH 18. Device-related adverse events: RR 11.87 (95% CI 4.74–29.74); NNH 11. Trial sequential analysis supported firm evidence for overall, deep, and superficial SSI. Intended duration of therapy was not a significant effect modifier for overall SSI, nor were device pressure or surgical specialty; the optimal duration and pressure on closed incisions remain undetermined. Most trials used PICO (4325 pt) or PREVENA (3000), with the remainder using miscellaneous single-use or traditional NPWT systems. Conclusion iNPWT reduces overall, superficial, and deep SSI and several wound complications, but increases dressing-related adverse events. The authors conclude that current evidence supports selective use in patients at elevated risk of incisional wound complications rather than universal prophylactic application. Strengths Largest RCT-only systematic review to date: 85 trials and nearly 17,000 patients. Prospective protocol, dual-reviewer methodology, RoB 2/GRADE assessment, sensitivity analyses, and trial sequential analysis. Reports absolute benefit and harm with clinically interpretable NNT/NNH. Limitations Major clinical heterogeneity across operations, wound classes, devices, pressure settings, dressings, and outcome definitions. Only 9/85 trials were low risk of bias; 71 had “some concerns.” Blinding is difficult with a visible dressing intervention, and adverse-event reporting was inconsistent. Several large, rigorous individual trials reported null results, suggesting the pooled effect may overstate benefit in some settings. Subgroup analyses were trial-level and exploratory; direct breast/plastic surgery representation was small. Clinical relevance For reconstructive surgeons, these data suggest iNPWT in patients at increased risk for incisional wound complications. The meta-analysis supports an overall SSI benefit, but it does not establish routine use in breast or plastic surgery cases. Editorial notes This massive systematic review finds that iNPWT can reduce incision-related complications, but the headline RR of 0.64 should not be interpreted as a universal 36% SSI reduction for plastic surgery patients. Breast and plastic surgery accounted for only 705 of 16,980 patients (4.2%), and some of the largest individual RCTs in other specialties were negative. The most useful result is the absolute tradeoff: one SSI prevented for every 21 patients treated versus one blistering event for every 18. Blistering is less consequential than an SSI, so these NNT/NNH values are not clinically equivalent, but they make indiscriminate use difficult to justify. For reconstructive practice, the unanswered question is not whether iNPWT works, but instead, which patients have a sufficiently high baseline wound risk for the benefit and cost to outweigh dressing-related morbidity.

  • Patient Preferences for Postmastectomy Breast Reconstruction

    Authors: Shammas RL, Hung A, Mullikin A, Sergesketter AR, Lee CN, Reed SD, Fish LJ, Greenup RA, Hollenbeck ST Affiliation: Duke University; Durham VA Health Care System; The Ohio State University; Yale University; University of Virginia Journal: JAMA Surgery, December 2023 PMID: 37755818 Background 20-40% of patients experience dissatisfaction or decisional regret after breast reconstruction Adaptive choice-based conjoint (ACBC) analysis is a survey-based method used in marketing research to determine how consumers value different attributes of a product In healthcare, ACBC can theoretically help identify individual-level preferences to promote shared decision-making between patients & clinicians Objective Identify which attributes of breast reconstruction matter most to women considering surgery and determine how priorities differ between respondents who prefer flap versus implant-based reconstruction Methods Design: Web-based, cross-sectional study from 2022-2023 Sample: Of 730 women recruited for the study, only 406 completed the survey (Duke: 105, Love Research Army Registry: 301). Mean age = 55.8 years; 89% were White and 73% married. Eligibility: Women with a new diagnosis of or genetic predisposition to breast cancer who presented to Duke for consultation for postmastectomy reconstruction OR women identified through the Love Research Army Registry. Exclusion criteria: Age younger than 18 years, metastatic disease, or did not consider undergoing postmastectomy breast reconstruction Attributes: Breast appearance, abdominal morbidity (0%, 25%, 50%), recovery (2, 4, 8 weeks), additional operations (1, 2, 3), and major complications (5%, 15%, 30%). Hypothetical Flap scenario: abdominal morbidity risk 25%, recovery time 8 weeks, 1 additional operation, complication risk 30% Hypothetical Implant scenario: abdominal morbidity risk 0%, recovery time 4 weeks, 2 additional operations, complication risk 15% Outcomes: Relative importance, part-worth utilities, and maximum acceptable risks. Results Most important attribute in decision-making process was risk of abdominal morbidity (RI 28%), followed by risk of major complications (25%), additional operations (23%), breast appearance (13%), & recovery time (11%) Most respondents (85%) preferred implant profile --> these respondents most valued abdominal morbidity, risk of complications, & number of additional operations Respondents who preferred the flap profile (15%) most valued number of additional operations, breast appearance, & complication risk Participants who were married or college educated were more likely to prefer the flap profile, while income over $75,000 was associated with decreased likelihood of choosing flap profile Among 344 respondents who preferred the implant profile, 34% actually preferred the flap appearance Conclusion This study may lay the foundation for decision support tools that can help promote shared decision making in breast reconstruction. Key takeaways Abdominal morbidity, fear of complications, and the need for additional operations were the most important considerations in selecting implant vs flap reconstruction Most respondents (85%) preferred the study's implant scenario, largely because of lower modeled abdominal morbidity and complication risk Respondents who preferred the flap scenario tended to favor fewer additional operations & flap appearance Strengths and Limitations Strengths ACBC analysis seeks to examine how women value different aspects of reconstructive care Attributes selected in the study were identified by literature review, surgeon input, semi-structured interviews, and cognitive pretesting. Two recruitment sources Limitations Self-reported, cross-sectional study with substantial noncompletion Predominantly White, upper-middle-class cohort limits generalizability Only simplified implant and abdominal-flap scenarios were modeled. Study failed to capture the nuances inherent in real clinical breast reconstruction Preferences were hypothetical. Actual choice of reconstruction, patient satisfaction, decisional regret, and clinical outcomes were not tested. Clinical relevance This study has limited clinical relevance given its findings were derived from hypothetical scenarios. Real-world decision-making regarding choice of breast reconstruction is highly nuanced. Not all women are in fact candidates for both implant and flap reconstruction due to comorbidities, body habitus, history of radiation, or prior reconstructive history. While the attributes used in the ACBC were rigorously identified and tested, the authors did not explain where they came up with the hypothetical risks of complications, additional operations, or abdominal morbidity used in their survey. Editorial notes It is not surprising that many women preferred a 0% chance of abdominal morbidity with implants compared to a non-zero chance of abdominal morbidity with flap reconstruction. This study likely significantly over-estimates the “implant preference” and underestimates the risk of reoperation and dissatisfaction with implants. The finding that married & college-educated women were more likely to prefer flap reconstruction but women with higher incomes were less likely to prefer flap reconstruction was contradictory.

  • Surgical outcomes of prepectoral two-stage breast reconstruction in patients treated with pembrolizumab or CDK4/6 inhibitors

    Authors: Ibrahim Y, Alnaseri T, Gupta N, Hall A, Carter M, Kwan L, Demirjian M, McCann KE, Teshome M, Delong MR Affiliation: University of California, Los Angeles Journal: Plastic and Reconstructive Surgery, March 2026 PMID: 41825078 Key takeaways Pembrolizumab (PD-1 inhibitor) exposure was associated with more seromas during tissue expansion (44.4% vs 27.0%) and more major complications (4x) and reoperations (5.4x) after implant exchange. CDK4/6 inhibitor use showed no increase in major complications or reoperations under this center’s practice of holding therapy for about 1 week preoperatively. This is a retrospective study and it may be underpowered, as it includes a relatively small number of patients receiving either pembrolizumab or CDK4/6 inhibitors Background Pembrolizumab and CDK4/6 inhibitors are increasingly used in breast cancer treatment, but their effects on staged implant reconstruction are poorly characterized. This study examines complications after immediate prepectoral tissue expander placement and subsequent implant exchange. Objective Evaluate whether pembrolizumab or CDK4/6 inhibitor exposure is associated with surgical complications during two-stage prepectoral breast reconstruction. Methods Design: Retrospective, single-center review of immediate two-stage prepectoral reconstructions performed January 2018-October 2024. Population: 472 patients (823 breasts); median age 46.7 years, median BMI 23.5 kg/m², median follow-up 12 months. Twenty-seven received pembrolizumab and 30 received a CDK4/6 inhibitor. Exclusions: Autologous, delayed, or direct-to-implant reconstruction; chemotherapy after implant exchange; <3 months follow-up. Perioperative practice: Surgery generally 3-6 weeks after chemotherapy; implant exchange generally after adjuvant chemotherapy or immunotherapy. CDK4/6 inhibitors were typically held 1 week before surgery; surgery could be delayed for ANC <1.0 or active issues. Outcomes: Infection, hematoma, seroma, mastectomy-flap necrosis, implant removal, reoperation, and major complications (readmission or return to OR), assessed separately after expander and implant surgery. Statistics: Chi-square/Fisher exact tests and Wilcoxon rank-sum tests. Pembrolizumab analyses were additionally adjusted for chemotherapy type. No prespecified primary endpoint, power calculation, alpha plan, or multiple-comparison correction was reported. Results Pembrolizumab: n = 27 After tissue expander placement, seroma was more common in patients receiving Pembro than in those not receiving Pembro: 44.4% vs 27.0% (p=0.049). Major complications after expander placement were not increased with Pembro (22.2% vs 26.6% without, p=0.61). Other complication rates were also similar. After implant exchange, major complications were higher with Pembro (26.3% vs 8.0% without, p=0.019). Reoperation after implant exchange was also higher: 19.1% vs 3.7% without (p=0.011). After adjustment for chemotherapy type, Pembro was associated with approximately 4× higher odds of major complications and 5.4× higher odds of reoperation after implant exchange. CDK4/6 inhibitors: n = 30 After tissue expander placement, major complication rates were essentially identical: 26.4% with CDK4/6 inhibitors vs 26.3% without (p=0.97). Reoperation rates were also similar: 23.3% vs 23.1% without (p=0.97). Minor infection was lower in the CDK4/6 group: 0% vs 12.4% (p=0.037), although this was based on a small treated cohort. After implant exchange, CDK4/6 inhibitor use was not associated with significantly higher rates of major complications, reoperation, infection, explantation, necrosis, or capsular contracture. The rate of seroma after implant exchange was higher with CDK4/6 inhibitors (8.0% vs 1.5%), but this did not reach statistical significance (p=0.076). Conclusion The authors conclude that pembrolizumab exposure is associated with increased seroma during expansion and increased major complications and reoperations after implant exchange, warranting further study. CDK4/6 inhibitor use was not associated with increased wound healing complications in this cohort. Strengths Addresses a timely, clinically relevant question with stage-specific reconstructive outcomes. Includes the institution’s full prepectoral experience over more than 6 years and reports practical perioperative management. Limitations Retrospective, single-center design with very small cohorts (27 pembrolizumab; 30 CDK4/6), which may be underpowered to detect complications Major confounding by indication and treatment intensity: the groups differed in chemotherapy, radiation, axillary surgery, age, race, and corticosteroid exposure; adjustment was limited mainly to chemotherapy type. Only 21/27 pembrolizumab patients reached implant exchange versus 402/445 controls, creating potential selection/survivorship bias in second-stage comparisons. Many outcomes were tested without reported multiplicity correction; the expander-seroma result was borderline (p=0.0494). Long-term implant outcomes remain inadequately studied. Clinical relevance Given the very small cohorts (27 pembrolizumab and 30 CDK4/6 inhibitor patients), these findings should be considered preliminary. Patients receiving pembrolizumab warrant closer counseling regarding reconstructive complications and careful coordination of implant-exchange timing with systemic therapy. CDK4/6 inhibitors were not associated with increased surgical complications when held for 1 week preoperatively, but the study is too small to establish equivalence or definitive safety.

  • ASSERT Trial: Antibiotics and surgical site infection in expander-based breast reconstruction

    Authors: Kaur S, Gastman B, Broderick KP, Momoh AO, Phillips BT, Schwarz G, Hanson SE, Hespe GE, Cooney CM, Sommers K, Leu CS, Rohde CH; ASSERT Group Affiliation: The Plastic Surgery Foundation; Cleveland Clinic; Johns Hopkins University; University of Michigan; Duke University; University of Chicago; Columbia University Journal: Annals of Surgical Oncology, April 2026 PMID: 41085801 (primary article), ASO Author Reflections Key takeaways ASSERT did not establish noninferiority: 30-day SSI was 17% with single-dose prophylaxis versus 11% with 7 postoperative days. The trial was severely underpowered: only 214 patients were analyzed versus 922 required; enrollment stopped when funding ended. The 6% noninferiority (i.e. clinically meaningful) margin allowed an assumed SSI increase from 12% to 18%, a 50% relative increase. Despite the failed noninferiority test, the authors suggest the findings support CDC-limited prophylaxis; the data are more appropriately considered inconclusive. Background Prophylactic antibiotic duration after immediate tissue expander breast reconstruction (TE-BR) varies widely. CDC guidance recommends no postoperative prophylactic antibiotics after incision closure for clean or clean-contaminated surgery, even with drains, but implant-based reconstruction has unique infection and device-loss consequences. Objective Determine whether a single preoperative antibiotic dose is noninferior to the same perioperative regimen plus 7 days of postoperative oral antibiotics for preventing 30-day surgical site infection (SSI) after immediate TE-BR. Methods Design: Prospective, open-label, multicenter randomized noninferiority trial at five US academic reconstructive centers. Enrollment: 499 patients approached from May 2021-May 2023; 235 randomized; 21 were withdrawn after randomization and 214 were analyzed (102 single-dose, 112 week-postoperative). Population: Women ≥18 undergoing unilateral or bilateral mastectomy for cancer or prophylaxis with immediate prepectoral or submuscular TE-BR, with or without acellular dermal matrix (ADM). Key exclusions: Direct-to-implant, delayed or autologous reconstruction; prior chest wall radiation; prior reconstruction on the expander side. Intervention: Weight-based cefazolin within 60 minutes before incision with indicated intraoperative redosing; allergy alternatives permitted. The comparator received the same plus 7 days of oral antibiotics. Primary endpoint: CDC-defined SSI within 30 days. Secondary outcomes included later infection, hospitalization, expander/implant loss, cultures, and antibiotic-related adverse events. Statistics: Investigators assumed 12% SSI with 7 postoperative days versus 18% with single-dose prophylaxis and set a 6% absolute noninferiority margin—equivalent to allowing a 50% relative increase in SSI. With one-sided α=0.025 and 80% power, 922 evaluable patients were required; only 235 were randomized before funding ended. Results Baseline/operative profile: Mean age ~49 years; 70% bilateral mastectomy; approximately 50% prophylactic mastectomy; ADM used in 75%; 90% of expanders were prepectoral. Primary endpoint: 30-day SSI occurred in 17/102 (17%) vs 12/112 (11%)—a 6-percentage-point absolute difference and approximately 55% relative difference. Noninferiority was not established (p=0.496). 180-day infection: 24% vs 18% (p=0.476); median onset 21 vs 29 days. Expander removal for infection: Within 30 days, 6% vs 2% (p=0.232); any infection-related TE removal was 18% vs 12% (p=0.503). Other outcomes: Thirty-day hospitalization was 9% vs 6%; return to OR 11% vs 10%. Adverse events: Three patients receiving 7 postoperative days developed antibiotic-related rash or nausea/vomiting; none were reported in the single-dose group. Higher BMI (p=0.048) and mastectomy weight (p=0.033) were associated with SSI within 180 days. Conclusion The authors conclude that ASSERT did not definitively demonstrate noninferiority of a single preoperative dose versus 7 postoperative days and found no statistically significant evidence that the 7-day regimen was superior. Despite the failed noninferiority test, they state that the findings support limiting prophylactic antibiotics in accordance with CDC guidance. Strengths Randomized, geographically diverse multicenter design. Standardized CDC SSI definition with investigator review of uncertain cases and follow-up beyond 30 days. Contemporary population: 90% prepectoral reconstruction and 75% ADM use. Limitations Severely underpowered and prematurely stopped: 214 patients were analyzed versus 922 required. Funding ended before accrual was complete; COVID-related interruptions and increasing use of excluded direct-to-implant reconstruction also impaired enrollment. The authors’ 6% noninferiority margin allowed an assumed SSI increase from 12% to 18%, a 50% relative increase, without a justification for why that degree of excess infection should be deemed noninfeiror. Open-label design, surgeon-level variation in technique, and underpowered subgroup analyses add uncertainty; 21 randomized patients were not analyzed, making the reported ITT approach effectively modified ITT. Clinical relevance ASSERT does not establish that single-dose prophylaxis is noninferior or equivalent to 7 postoperative days. With SSI 17% versus 11% and a trial far short of its required sample, these data should not justify reducing prophylaxis; the principal finding is continued uncertainty. Editorial notes While we applaud the authors for their efforts with the ASSERT trial, it simply does not answer its primary question. The trial was severely underpowered and failed to establish noninferiority, yet the authors characterize the outcomes as comparable and argue that the findings support limited antibiotic prophylaxis; that interpretation is at best overreaching and at worst a misrepresentation. More importantly, the authors' chosen 6% clinically meaningful margin would accept an increase from 12% to 18% SSI, a 50% relative increase, as noninferior, without a clear justification for why that degree of added infection is acceptable. A potential increase of that magnitude is not trivial in tissue expander reconstruction; SSI can lead to IV antibiotics, hospitalization, reoperation, expander loss, and delay of reconstruction or oncologic care, as the authors clearly note. That potential harm is clinically far more consequential than the three minor antibiotic-related reactions reported in the 7-day group. With observed SSI of 17% versus 11% and infection-related expander removal also numerically favoring 7 days, the defensible conclusion is uncertainty, not equivalence and not evidence sufficient to reduce prophylaxis. Antibiotic stewardship is a valid goal, but ASSERT is not adequately powered to make any substantiated claims to reduce antibiotic prophylaxis. Lastly, the authors’ description of ASSERT as Level I evidence is difficult to reconcile with the ASPS evidence hierarchy, which specifically requires adequate power for a therapeutic RCT to qualify as Level I. The study achieved only 23% of its required sample and failed its primary noninferiority analysis. Calling this Level I evidence risks overstating the certainty of a fundamentally inconclusive trial.

  • Free forearm flaps for head and neck reconstruction: fewer revisions and flap failures with two venous anastomoses – a 25-year prospective study

    Authors: Kuijpers CJ, Van Cann EM, Dieleman FJ, Bergsma JE, van Es RJJ, Rosenberg AJWP Affiliation: University Medical Center Utrecht, the Netherlands Journal: International Journal of Oral and Maxillofacial Surgery, January 2026 PMID: 41130859 Key takeaways Two venous anastomoses were associated with fewer takebacks and flap failures in free forearm flap head and neck reconstruction. Primary RFFF Revision: 8.8% with one vein vs 2.9% with two veins; P = 0.045. Failure: 8.8% with one vein vs 2.1% with two veins; P = 0.018. Full cohort (Ulnar and radial forearm flaps) Revision: 8.3% with one vein vs 2.8% with two veins; P = 0.031. Failure: 6.7% with one vein vs 2.0% with two veins; P = 0.033. A single venous anastomosis independently predicted vascular revision (adjusted OR 3.16; P = 0.039) and flap failure (adjusted OR 4.50; P = 0.015). Background Free forearm flaps are workhorse flaps for head and neck reconstruction. Vascular compromise remains uncommon but consequential, and the value of a second venous anastomosis remains debated. Objective Determine whether two venous anastomoses reduce surgical vascular revision and flap failure compared with one venous anastomosis in free forearm flap head and neck reconstruction. Methods Design: Prospective single-center cohort, 1998–2023; Level III evidence. Population: 364 patients, 368 free forearm flaps. 314 radial free forearm flaps (RFFF); 54 ulnar free forearm flaps (UFFF). 359/368 flaps (97.6%) were primary reconstructions. Primary analysis: 306 primary RFFF. One vein: 68. Two veins: 238. Full cohort analysis: All RFFF and UFFF, primary and secondary reconstructions (368). One vein: 120. Two veins: 248. Baseline balance: Primary RFFF groups were similar for sex, age, ASA class, T-stage, prior radiotherapy, and sampled smoking status. In the full cohort, one-vein patients were slightly older and UFFF were disproportionately in the one-vein group. Technique: Arterial anastomoses were end-to-end. Venous anastomoses were end-to-end or end-to-side; couplers were introduced in 2019 at surgeon discretion. One surgeon routinely completed a single venous anastomosis, while the other three routinely completed two. Venous drainage, full cohort: One-vein flaps used the deep system in 92.5%. Two-vein flaps used both superficial and deep systems in 89.3%. Internal jugular vein was the recipient vein in 93.2% of venous anastomoses. Outcomes: Surgical vascular revision and partial or total flap failure within 4 weeks. Statistics: Fisher exact testing for group comparisons; multivariable logistic regression in the full cohort adjusted for age and flap type. Results Primary RFFF subgroup Vascular revision: 6/68 (8.8%) with one vein vs 7/238 (2.9%) with two veins; P = 0.045; RR 3.00, 95% CI 1.04–8.63. Flap failure: 6/68 (8.8%) with one vein vs 5/238 (2.1%) with two veins; P = 0.018; RR 4.20, 95% CI 1.32–13.34. Overall primary RFFF failure: 11/306 (3.6%): 9 total and 2 partial failures. Revision etiology: 7 venous, 3 arterial, 3 combined arterial/venous. Revision timing: 10/13 revisions occurred on postoperative day 1. Salvage after revision: 10/13 revised flaps (76.9%) were salvaged. Full cohort Vascular revision: 10/120 (8.3%) with one vein vs 7/248 (2.8%) with two veins; P = 0.031; RR 2.95, 95% CI 1.15–7.56. Flap failure: 8/120 (6.7%) with one vein vs 5/248 (2.0%) with two veins; P = 0.033; RR 3.31, 95% CI 1.11–9.89. Overall flap survival: 355/368 (96.5%). Overall flap failure: 13/368 (3.5%): 11 total and 2 partial failures. Revision etiology: 10 venous, 4 arterial, 3 combined arterial/venous. Revision timing: 12/17 revisions occurred on postoperative day 1. Salvage after revision: 13/17 revised flaps (76.5%) were salvaged. UFFF: 2/47 one-vein UFFF failed; 0/7 two-vein UFFF failed. Multivariable analysis, full cohort Surgical vascular revision: one vs two veins, adjusted OR 3.16; 95% CI 1.06–9.44; P = 0.039. Flap failure: one vs two veins, adjusted OR 4.50; 95% CI 1.34–15.05; P = 0.015. Age and flap type were not significantly associated with either outcome. Conclusion In this 25-year prospective cohort, two venous anastomoses were associated with lower vascular revision and flap failure rates than one venous anastomosis. The authors conclude that a second venous anastomosis should be considered to reduce flap failure risk, while acknowledging that confirmation requires randomized trials or forearm flap-specific meta-analysis. Strengths Consecutive prospective cohort with clear early vascular endpoints. 25-year institutional experience. Separate, cleaner analysis of primary RFFF. Same directional signal in both the primary RFFF subgroup and full cohort. Limitations Nonrandomized allocation; number of veins was influenced by surgeon preference. Single-center, four-surgeon series over a long period with evolving technique and perioperative practice. Smoking was not prospectively documented and was only retrospectively sampled. Low event rates yield wide confidence intervals and limited subgroup power. Cannot determine whether benefit comes from simply adding a second vein or specifically from dual-system drainage. Venae comitantes size was not reported. Clinical relevance For RFFF or UFFF head and neck reconstruction, this study supports a low threshold for two venous anastomoses when anatomy and recipient vessels allow. The absolute flap failure reduction was clinically meaningful: 8.8% to 2.1% in primary RFFF and 6.7% to 2.0% in the full cohort. Editorial notes This study asks a long-debated question: does adding a second venous anastomosis reduce takeback and flap loss in head and neck reconstruction? In this cohort, one-vein flaps had consistently higher revision and failure rates in both the primary RFFF subgroup and the full cohort. The main caveat is confounding. Anastomosis number was not randomized and may reflect surgeon preference, era, flap type, recipient-vessel quality, ischemia time, or defect complexity. Failures were also not stratified by surgeon or early versus late study period. A key missing detail is venae comitantes caliber. A prior study (Yu 2011) suggested that deep-system drainage is reliable when the venae comitantes are at least 1 mm at the wrist incision, while smaller venae comitantes should prompt use of the superficial system. Kuijpers reports whether the deep and/or superficial systems were used, but not VC size. That distinction matters: the worse outcomes in one-vein flaps may reflect inadequate deep-system caliber, lack of second-system redundancy, or both. Because most two-vein flaps used both superficial and deep systems, this paper is best read as support for dual outflow when feasible, not definitive proof that any two equivalent veins are superior to one.

  • Long-term outcomes of component separation for abdominal wall hernia repair

    Authors: Fry BT, Schoel LJ, Howard RA, Thumma JR, Kappelman AL, Hallway AK, Ehlers AP, O’Neill SM, Rubyan MA, Shao JM, Telem DA Affiliation: University of Michigan, Ann Arbor Journal: JAMA Surgery, January 2025 PMID: 39535784 Key takeaways Component separation use surged: 1.6% to 21.4% of inpatient repairs from 2007–2021. Despite being used for more complex patients, component separation had lower 10-year operative recurrence than repairs without it. The absolute recurrence difference was modest: 11.2% vs 12.9% at 10 years, favoring component separation. High-volume surgeons had statistically lower recurrence, but the clinical effect was small: 11.9% vs 13.6%. Claims data cannot assess hernia size, anterior vs posterior release, true clinical recurrence, or appropriateness of technique use. Background Component separation is used to achieve midline fascial closure in large or complex ventral hernias. Its use has expanded rapidly, especially after renewed interest in posterior component separation and transversus abdominis release, but population-level long-term recurrence data have been limited. Objective To evaluate contemporary national trends in component separation use and compare long-term operative recurrence after ventral hernia repair with versus without component separation. A secondary aim was to determine whether surgeon component-separation volume was associated with recurrence. Methods Design: Retrospective cohort study using 100% Medicare administrative claims data; observational Level III evidence. Study period: January 1, 2007, through December 31, 2021; analysis performed 2024. Population: Adults 18 years or older undergoing elective inpatient ventral hernia repair. Hernia types included: Ventral, incisional, umbilical, and epigastric anterior abdominal wall hernias. Exclusions:◦ Prior hernia repair within at least 2 years before index operation.◦ Repairs coded as recurrent ventral hernia.◦ Non–Fee-for-Service Medicare patients.◦ Cases lacking concurrent CPT code for hernia repair. Exposure: Component separation identified by CPT code 15734 for myofascial release with concurrent ventral hernia repair coding. Primary endpoints: Annual proportion of inpatient ventral hernia repairs using component separation. Operative recurrence up to 10 years. Secondary endpoint: Operative recurrence after component separation stratified by surgeon volume. Recurrence definition: Subsequent hernia operation; this is operative recurrence, not true clinical recurrence. Statistical approach: Cox proportional hazards models adjusted for age, sex, race and ethnicity, comorbidities, hernia subtype, operative approach, mesh use, component separation, and year of surgery. Hospital-level clustering was used for the primary model; surgeon-level clustering was used for surgeon-volume analysis. Results Cohort characteristics Total patients: 218,518 Medicare beneficiaries. Component separation: 23,768 patients, or 10.9%. No component separation: 194,750 patients, or 89.1%. Mean age: 69.1 years. Sex: 58.5% female, 41.5% male. Median follow-up: 7.2 years. Compared with non–component separation patients, those receiving component separation were: Slightly younger. More often male. More comorbid, including higher obesity prevalence. More likely to undergo open repair. More likely to receive mesh. Utilization trend Total inpatient ventral hernia repairs decreased from 17,661 in 2007 to 7,330 in 2021. Component separation use increased from 1.6% in 2007 to 21.4% in 2021. Operative recurrence Adjusted cumulative operative recurrence was lower with component separation: 1 year: 0.7% with component separation vs 0.9% without. 3 years: 4.2% vs 4.9%. 5 years: 6.8% vs 7.9%. 10 years: 11.2% vs 12.9%; P = .003. This is notable because component separation is generally reserved for larger, more complex, or multiply recurrent hernias, which should bias toward higher recurrence rather than lower recurrence. Surgeon volume Surgeon-specific data were available for 23,627 component separations, performed by 6,480 surgeons. After Medicare volume adjustment: 72.4% of surgeons performed fewer than 2 component separations per year. 97.4% performed fewer than 5 component separations per year. High-volume surgeons were defined as the top 5% by annual component separation volume. Median annual volume: Low-volume group: 1.2 cases/year. High-volume group: 4.9 cases/year. Ten-year operative recurrence: High-volume surgeons: 11.9%. Low-volume surgeons: 13.6%. P = .004. Conclusion Component separation was associated with lower long-term operative recurrence after ventral hernia repair among Medicare beneficiaries, despite being used in patients likely to have more complex hernias. Surgeon volume was statistically associated with recurrence, but the absolute effect was small. Strengths Very large national cohort using 100% Medicare claims. Long median follow-up of 7.2 years, with recurrence tracked up to 10 years. Captures real-world practice across a broad range of surgeons, not just expert hernia centers. Quantifies both adoption trends and long-term recurrence, which prior studies often did not. Limitations Operative recurrence underestimates true clinical recurrence because it only captures patients who undergo another operation. Medicare claims lack key surgical details: hernia width, loss of domain, wound class, mesh plane, mesh type, fixation strategy, fascial closure quality, and prior abdominal wall history. Cannot distinguish anterior component separation, posterior component separation, and transversus abdominis release. Selection bias is unavoidable: patients selected for component separation likely differed in ways not measurable in claims. Surgeon-volume analysis is imperfect because Medicare volume was inflated to estimate all-payer volume. Lower recurrence in the component separation group could partially reflect inappropriate use in smaller hernias, where recurrence risk is already low.

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