CD31 defines a subpopulation of human adipose-derived regenerative cells with potent angiogenic effects.

Cellular heterogeneity represents a major challenge for regenerative treatment using freshly isolated Adipose Derived Regenerative Cells (ADRCs). Emerging data suggest superior efficacy of ADRCs as compared to the ex vivo expanded and more homogeneous ADRCs (= ASCs) for indications involving (micro)vascular deficiency, however, it remains unknown which ADRC cell subtypes account for the improvement. Surprisingly, we found regarding erectile dysfunction (ED) that the number of injected CD31+ ADRCs correlated positively with erectile function 12 months after one bolus of autologous ADRCs. Comprehensive in vitro and ex vivo analyses confirmed superior pro-angiogenic and paracrine effects of human CD31+ enriched ADRCs compared to the corresponding CD31- and parent ADRCs. When CD31+, CD31- and ADRCs were co-cultured in aortic ring- and corpus cavernous tube formation assays, the CD31+ ADRCs induced significantly higher tube development. This effect was corroborated using conditioned medium (CM), while quantitative mass spectrometric analysis suggested that this is likely explained by secretory pro-angiogenic proteins including DKK3, ANGPT2, ANAX2 and VIM, all enriched in CD31+ ADRC CM. Single-cell RNA sequencing showed that transcripts of the upregulated and secreted proteins were present in 9 endothelial ADRC subsets including endothelial progenitor cells in the heterogenous non-cultured ADRCs. Our data suggest that the vascular benefit of using ADRCs in regenerative medicine is dictated by CD31+ ADRCs.

Short term treatment of secondary lymphedema with hyaluronidase injections reduces mouse hindlimb lymphedema.

Lymphedema is a common complication following breast cancer treatment with axillary lymphadenectomy and radiotherapy. Currently, there is no curative treatment for this disease, hence there is a need for new therapeutic suggestions. The aim of this study was to investigate the effect of hyaluronidase (HYAL) injections after inducing hindlimb lymphedema in 36 female C57BL/6 mice. HYAL injections were administered every second day for 14 days in three groups: (1) HYAL for 1 week followed by saline for 1 week, (2) HYAL for 2 weeks, and (3) saline injections for 2 weeks. Volume of the lymphedema limb was weekly assessed with micro-computed tomography (µ-CT) scans for a total course of 6 weeks. Lymph vessel morphometry was assessed in the end of the study after staining cross-sections of the hindlimb for anti-LYVE-1 blindly. Lymphatic function was assessed by lymphoscintigraphy to assess lymphatic clearance. There was a significant reduction of the volume of lymphedema in mice treated with HYAL-7 compared with mice treated with HYAL-14 (p < 0.05) and saline (p < 0.05). No differences were detected in lymph vessel morphometry and the lymphoscintigraphy between groups. Short-term treatment with HYAL-7 might be a potential therapeutic suggestion for secondary lymphedema induced in mouse hindlimbs. In the future, clinical studies are needed to investigate the potential of HYAL treatment in human beings.

Treatment of Breast Cancer-Related Lymphedema With Topical Tacrolimus: A Prospective, Open-Label, Single-Arm, Phase II Pilot Trial.

PURPOSE: Breast cancer-related lymphedema (BCRL) is a chronic, progressive side effect of breast cancer treatment, occurring in one-third of patients treated with axillary lymph node dissection and nodal radiotherapy. Cluster of differentiation 4-positive (CD4+) cells plays a key role in BCRL by facilitating inflammation and inhibiting lymphangiogenesis. Tacrolimus is an anti-inflammatory and immunosuppressive macrolide that targets CD4+ cells. Treatment of lymphedema with topical tacrolimus has revealed promising results in preclinical trials. This clinical trial was aimed at evaluating the feasibility, safety, and effect of tacrolimus in women with stage I or II BCRL, according to the International Society of Lymphology. METHODS: We conducted this open-label, single-arm, phase II pilot trial from September 2020 to April 2021. Eighteen women with BCRL stage I or II BCRL were treated with topical tacrolimus for 6 months and followed up at 3 and 6 months. The primary outcome was arm volume, and secondary outcomes were the lymphedema index (L-Dex), health-related quality of life (HRQoL), lymph flow and function, and safety and feasibility of the trial design. RESULTS: The mean lymphedema arm volume and L-Dex reduced significantly by 130.44 ± 210.13 mL (p < 0.05; relative reduction: 3.6%) and 3.54 ± 4.98 (p < 0.05), respectively, and health-related quality of life scores was improved significantly (p < 0.05). According to the MD Anderson scale, in terms of lymph flow and function, three patients (16.7%) showed improvement, while none showed worsening. Lymph flow or function showed no change according to the Arm Dermal Backflow scale. CONCLUSION: In this trial, treatment with tacrolimus was safe and feasible in women with stage I or II BCRL. Tacrolimus alleviated BCRL in terms of improved arm volume, L-Dex, and HRQoL. Assessments of lymph flow and function were positive, although inconclusive. Larger randomized controlled trials are required to verify these findings. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04541290.

Can prophylactic incisional negative pressure wound therapy Reduce Wound Complications After Inguinal Lymph Node Dissection for Melanoma? Results from a Randomized Controlled Trial.

Background: Inguinal lymph node dissection (ILND) is associated with a high complication rate. Retrospective studies suggest that incisional negative pressure wound therapy (iNPWT) might reduce complications, especially seroma, following ILND. Methods: This was a prospective multicenter, randomized (1:1), open-labeled, parallel-group trial. Patients with macrometastic melanoma to the inguinal lymph nodes and eligible for ILND were randomized to receive either iNPWT for 14 postoperative days or conventional wound dressing. The primary outcome was seroma incidence. Secondary outcomes included surgical-site infection, wound rupture, wound necrosis, hematoma, rehospitalization and readmission rates between groups. All outcomes were registered 3 months after ILND and analyzed according to the intention-to-treat principle. Results: The trial was terminated early due to a low recruitment rate as a consequence of a change in the national treatment protocol, and the estimated sample size was not reached. Twenty patients were included and randomized in the study. The trial showed less seroma formation between the iNPWT 6/11 (55%) and control 7/9 (78%) groups; however, this was not statistically significant (p = 0.29). Similarly, there were no differences in the rates of surgical-site infection (p = 0.63), wound rupture (p = 0.19), wound necrosis (p = 0.82), hematoma (p = 0.19), reoperation (p = 0.82) or readmission (p = 0.34) between groups. Conclusion: There was a tendency toward fewer complications in the iNPWT group, however this trial was underpowered and could not confirm the hypothesis that iNPWT reduces complications after ILND. Future randomized controlled trials are required to fully evaluate the treatment potential of iNPWT. Trial registration: The trial was prospectively registered at https://clinicaltrials.gov/ct2/show/NCT03433937.

Patients Decision-Making Characteristics Affects Gynecomastia Treatment Satisfaction: A Multicenter Study Using the BODY-Q Chest Module.

BACKGROUND: Patient satisfaction is the most critical outcome in gynecomastia treatment. However, patient satisfaction may be affected by the patient's decision-making trait, such as exhaustively searching for the best outcome or being content with an outcome that satisfies a preconceived requirement. OBJECTIVE: To assess whether patient's decision-making characteristic affect their satisfaction with gynecomastia treatment. METHODS: This was a cross-sectional study including patients treated for gynecomastia between January 2009 and December 2019 at two tertiary hospitals in Denmark. Alive patients were sent the BODY-Q: Chest module, the SF-36 questionnaire, and the Maximizer/Satisficer decision-making survey. Patients were classified as Maximizers if they scored more than 40 points on the Maximizer/Satisficer survey. Percentage score differences (PDs) in quality of life scales were calculated between Maximizers and Satisficers. RESULTS: In total, 192 gynecomastia patients were included in this study and classified as Maximizers (n = 152) or Satisficers (n = 40). Maximizers were younger and more had gynecomastia following abuse of anabolic steroids than Satisficers (p < 0.05). With respect to bodily satisfaction, Maximizers showed significantly worse satisfaction with nipples (PDs: - 12.98%), psychological function (PDs: - 13.68%) and social function (PDs: - 8.77%, p < 0.05). In addition, Maximizers had significantly worse emotional role functioning (- 11.03%), vitality (PDs: - 11.72%) and mental health (PDs: - 10.00%, p < 0.05). CONCLUSION: Patients exhibiting maximizing-type decision-making characteristics have worse satisfaction with gynecomastia treatment and poorer psychosocial health. This information may facilitate patient counseling and alignment of treatment expectations. LEVEL OF EVIDENCE IV: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Indocyanine green lymphangiography is superior to clinical staging in breast cancer-related lymphedema.

Precise staging of breast cancer-related lymphedema (BCRL) is important to guide treatment-decision making. Recent studies have suggested staging of BCRL using indocyanine green lymphangiography (ICG-L) based on the extent of lymphatic injury and dermal backflow patterns. Currently, the benefits of ICG-L compared to conventional clinical staging are unknown. For this study, we included 200 patients with unilateral BCRL. All BCRL patients were staged using ICG-L and clinical exam. The amounts of excess arm volume, fat mass and lean mass were compared between stages using Dual Energy X-Ray Absorptiometry. Multivariate regression models were used to adjust for confounders. For each increase in the patient's ICG-L stage, the excess arm volume, fat mass and lean mass was increased by 8, 12 and 6.5 percentage points respectively (P < 0.001). For each increase in the patient's clinical ISL stage, the volume was increased by 3.5 percentage points (P < 0.05), however no statistically significant difference in the lean and fat mass content of the arm was observed for ascending stages. However, the residual plots showed a high degree of variance for both ICG-L and clinical staging. This study found that ICG-L staging of BCRL was superior to clinical staging in forecasting BCRL excess arm volume, fat mass, and lean mass. However, there was a high degree of variance in excess arm volume, fat mass, and lean mass within each staging system, and neither the ICG-L nor clinical staging forecasted perfectly.

Development and Psychometric Validation of a Patient-Reported Outcome Measure for Arm Lymphedema: The LYMPH-Q Upper Extremity Module.

BACKGROUND: A multiphased mixed-methods study was performed to develop and validate a comprehensive patient-reported outcome measure (PROM) for arm lymphedema in women with breast cancer (i.e., the LYMPH-Q Upper Extremity Module). METHODS: Qualitative interviews (January 2017 and June 2018) were performed with 15 women to elicit concepts specific to arm lymphedema after breast cancer treatment. Data were audio-recorded, transcribed, and coded. Scales were refined through cognitive interviews (October and Decemeber 2018) with 16 patients and input from 12 clinical experts. The scales were field-tested (October 2019 and January 2020) with an international sample of 3222 women in the United States and Denmark. Rasch measurement theory (RMT) analysis was used to examine reliability and validity. RESULTS: The qualitative phase resulted in six independently functioning scales that measure arm symptoms, function, appearance, psychological function, and satisfaction with information and with arm sleeves. In the RMT analysis, all items in each scale had ordered thresholds and nonsignificant chi-square p values. For all the scales, the reliability statistics with and without extremes for the Person Separation Index were 0.80 or higher, Cronbach's alpha was 0.89 or higher, and the Intraclass Correlation Coefficients were 0.92 or higher. Lower (worse) scores on the LYMPH-Q Upper Extremity scales were associated with reporting of more severe arm swelling, an arm problem caused by cancer and/or its treatment, and wearing of an arm sleeve in the past 12 months. CONCLUSIONS: The LYMPH-Q Upper Extremity Module can be used to measure outcomes that matter to women with upper extremity lymphedema. This new PROM was designed using a modern psychometric approach and, as such, can be used in research and in clinical care.

Cellulitis Is Associated with Severe Breast Cancer-Related Lymphedema: An Observational Study of Tissue Composition.

Cellulitis is a common complication in Breast Cancer-Related Lymphedema (BCRL). The excess amount of fat and lean mass in BCRL is a vital factor in patient stratification, prognosis, and treatments. However, it is not known whether cellulitis is associated with the excess fat and lean mass in BCRL. Therefore, this prospective observational study was designed to fundamentally understand the heterogonous biocomposition of BCRL. For this study, we consecutively enrolled 206 patients with unilateral BCRL between January 2019 and February 2020. All patients underwent Dual-Energy X-Ray Absorptiometry scans, bioimpedance spectroscopy, indocyanine green lymphangiography comprehensive history of potential risk factors, and a clinical exam. Multivariate linear and beta regression models were used to determine the strength of association and margins effect. Sixty-nine patients (33%) had at least one previous episode of cellulitis. Notably, a previous episode of cellulitis was associated with 20 percentage points more excess fat and 10 percentage points more excess lean mass compared to patients without cellulitis (p < 0.05). Moreover, each 1 increase in the patients BMI was associated with a 0.03 unit increase in the fat mass proportion of the lymphedema arm. Cellulitis was associated with more excess fat and lean arm mass in BCRL. In addition, patients BMI affect the proportion of fat mass in the arm.

Superomedial Reduction Mammoplasty Affects Patients' Ability to Breastfeed in a Distinct Manner: A Multicenter Study of 303 Patients.

BACKGROUND: Breast reduction by the superomedial technique can relieve symptoms related to breast hypertrophy; however, as the lateral and inferior portion of the breast parenchyma is removed and displaced, reduction mammoplasty may lead to an impaired ability to breastfeed. OBJECTIVES: The aim of this study was to assess patients' ability to breastfeed after superomedial reduction mammoplasty. METHODS: This was a cross-sectional study including patients treated with superomedial reduction mammoplasty between January 2009 and December 2018 at 2 tertiary hospitals in Denmark. Patients were stratified into 2 cohorts, depending on whether they had experienced childbirth before or after their reduction mammoplasty. Patients were sent specific questionnaires regarding maternity, breastfeeding before and after reduction mammoplasty, nipple sensitivity, and current demographic information. Operative details were retrieved from electronic medical records. RESULTS: In total, 303 patients were identified as eligible for this study (37 patients giving birth after and 266 before reduction mammoplasty). Fewer patients were able to breastfeed exclusively for the recommended 6 months after reduction mammoplasty (2/37, 5.41%) compared with before (92/266, 34.59%; P < 0.05). In addition, fewer patients were able to breastfeed at all after reduction mammoplasty (18/37, 48.64%) compared with before mammoplasty (241/266, 90.60%; P < 0.001). Patients unable to breastfeed after reduction mammoplasty had lower nipple sensitivity and more breast tissue excised (P < 0.05). CONCLUSIONS: Superomedial reduction mammoplasty seems to impair the patient's ability to breastfeed exclusively for the recommended 6 months. Patients of childbearing age considering reduction mammoplasty should be made aware that reduction mammoplasty reduces their breastfeeding capacity.

Prospective Validation of Indocyanine Green Lymphangiography Staging of Breast Cancer-Related Lymphedema.

Indocyanine green lymphangiography (ICG-L) allows real-time investigation of lymphatics. Plastic surgeons performing lymphatic reconstruction use the ICG-L for patient selection and stratification using the MD Anderson (MDA) and the Arm Dermal Backflow (ADB) grading systems. However, the applicability of ICG-L in evaluating breast cancer-related lymphedema (BCRL) is sparse and not well established. This study comprehensively examines the usability of ICG-L in the assessment of BCRL. We prospectively performed ICG-L in 237 BCRL patients between January 2019 and February 2020. The aim of this study was to assess the interrater and intrarater agreement and interscale consensus of ratings made using the MDA and ADB scales. Three independent raters performed a total of 2607 ICG-L assessments. The ICG-L stage for each grading system was correlated to the lymphedema volume to assess the agreement between the ICG-L stage and clinical severity. The interrater agreement was near perfect for the MDA scale (kappa 0.82-0.90) and the ADB scale (kappa 0.80-0.91). Similarly, we found a near-perfect intrarater agreement for the MDA scale (kappa 0.84-0.94) and the ADB scale (kappa 0.88-0.89). The agreement between the MDA and the ADB scales was substantial (kappa 0.65-0.68); however, the ADB scale systematically overestimated lower ICG-L stages compared to the MDA scale. The volume of lymphedema correlated slightly with MDA stage (Spearmans rho = 0.44, p < 0.001) and ADB stage (rs = 0.35, p < 0.001). No serious adverse events occurred. The staging of BCRL with ICG-L is reliable, safe, and provides unique disease information unobtainable with clinical measurements alone. The MDA scale seems to provide better disease stratification compared to the ADB scale.

Adipose-derived regenerative cells and lipotransfer in alleviating breast cancer-related lymphedema: An open-label phase I trial with 4 years of follow-up.

Patients with breast cancer-related lymphedema (BCRL) have reduced quality of life and arm function. Current treatments are palliative, and treatments improving lymphedema are lacking. Preclinical studies have suggested that adipose-derived regenerative cells (ADRCs) can alleviate lymphedema. We, therefore, aimed to assess whether ADRCs can alleviate lymphedema in clinical reality with long-term follow-up. We treated 10 patients with BCRL using ADRCs and a scar-releasing lipotransfer to the axillary region, and all patients were followed 1, 3, 6, 12, and 48 months after treatment. The primary endpoint was change in arm volume. Secondary endpoints were safety, change in lymphedema symptoms, quality of life, lymphedema-associated cellulitis, and conservative treatment use. There was no significant decrease in BCRL volume after treatment. However, self-reported upper extremity disability and arm heaviness and tension improved. Six patients reduced their use of conservative BCRL treatment. Five patients felt that their BCRL had improved substantially, and four of these would redo the treatment. We did not observe any cases of locoregional breast cancer recurrence. In this phase I study with 4 years of follow-up, axillary delivered ADRCs and lipotransfer were safe and feasible and improved BCRL symptoms and upper extremity function. Randomized controlled trials are needed to confirm the results of this study.

Age and Body Mass Index Affect Patient Satisfaction Following Reduction Mammoplasty: A Multicenter Study Using BREAST-Q.

BACKGROUND: Reduction mammoplasty effectively improves quality of life for women with macromastia. However, little is known whether surgical- or patient-related factors affect satisfaction. OBJECTIVE: The authors sought to investigate factors associated with altered patient satisfaction following reduction mammoplasty. METHODS: A cross-section study was performed by sending the BREAST-Q Reduction module to all patients who had undergone reduction mammoplasty between January 2009 and December 2018 at 2 tertiary Danish hospitals. Demographics and pre-, peri-, and postoperative details were gathered from electronic medical records. RESULTS: A total of 393 patients returned the questionnaire and were eligible for the study. Increasing age at the time of surgery was associated with higher satisfaction with breasts nipples, headache, psychosocial well-being, and outcome. Increased body mass index at the time of surgery negatively affected satisfaction with breasts and psychosocial well-being. Increase in body mass index after surgery was further associated with lower satisfaction with breasts, nipples, sexual well-being, and more pain in the breast area. Postoperative scar revision and wound infection was more common following inferior pedicle technique than superomedial technique and negatively affected satisfaction with outcome and pain in the breast area. CONCLUSIONS: Patients should be motivated to optimize their weight prior to reduction mammoplasty to achieve optimal satisfaction. Age was associated with improved patient satisfaction, which should considered when operating on younger patients. Postoperative complications affect patient satisfaction, and the superomedial technique seems to be a better choice than the inferior pedicle technique in medium-large breasts.

Comparison between stromal vascular fraction and adipose derived stem cells in a mouse lymphedema model.

Background: Lymphedema is one of the most common complications following breast cancer. Axillary lymph node dissection and radiotherapy are two well-known risk factors resulting in either removal or damage to the lymph nodes. As stem cells are known for their regenerative capabilities, they could theoretically repair/restore the damaged lymph vessels leading to a decrease in lymphedema.Methods: We evaluated the treatment of SVF and ASC on a mouse lymphedema model. Forty-five mice were allocated into three groups containing 15 mice each. The SVF group was injected with 100 µl containing 1 × 106 SVF, the ASC group with 100 µl ml containing 1 × 106 ASC and the NS with 100 µl ml of NS. Volumes of the mice were assessed weekly by µCT hindlimb volumetry for a total of 8 weeks. Lymph vessel morphometry was assessed by cross-sections of both hindlimbs stained for anti-LYVE1. Lymphatic function was assessed by lymphatic clearance.Results: The volume change between the groups was non-significant throughout all 8 weeks. The immunohistochemistry showed a statistically significant difference between the hindlimbs in ASC vs. NS group p = 0.032, 95% CI [-2121, -103].Conclusion: The volume of the hindlimbs showed that treatment with SVF or ASC yielded very similar results compared to the control group when assessed after 8 weeks. In week two the biggest difference between ASC and NS was seen but the difference diminished during the 8 weeks. The secondary outcomes showed that the lymph vessel lumen decreased when treated with ASC compared to the control group. Lymphoscintigraphy yielded non-significant results.

Risk of skin cancer in patients with vitiligo in Denmark: A nationwide cohort study.

BACKGROUND: Vitiligo is a depigmentation disorder associated with genetic loss of melanocytes and decreased melanin synthesis. The current literature is conflicting in regard to vitiligo patients' risk of cutaneous malignant melanoma and keratinocyte cancer. OBJECTIVE: To investigate the risk of cutaneous malignant melanoma and keratinocyte cancer in vitiligo patients. METHODS: We conducted a population-based study, including 2,339 subjects with a first-time vitiligo diagnosis between 1994 and 2017 and 23,293 age- and sex-matched (1:10) controls. To address surveillance bias, we included 12,380 subjects with a first-time diagnosis of lichen planus. RESULTS: Age was the only significant factor for cutaneous malignant melanoma in comparison of vitiligo with controls and lichen planus (hazard ratio 1.04, 95% confidence interval [CI] 1.03-1.05; and hazard ratio 1.02, 95% CI 1.01-1.04, respectively). Similarly, age was a significant factor for keratinocyte cancer in comparison of vitiligo with controls and lichen planus (hazard ratio 1.07, 95% CI 1.06-1.07; and hazard ratio 1.06, 95% CI 1.05-1.07). Male sex was an additional factor for keratinocyte cancer in comparison of vitiligo with lichen planus (hazard ratio 1.38; 95% CI 1.09-1.75). Phototherapy did not increase the risk of receiving a diagnosis of cutaneous malignant melanoma or keratinocyte cancer in the vitiligo cohort. CONCLUSION: We observed no significant difference in cutaneous malignant melanoma or keratinocyte cancer risk among vitiligo subjects. Phototherapy use was not associated with a higher skin cancer risk in vitiligo compared with other skin diseases.

Autologous versus implant-based breast reconstruction: A systematic review and meta-analysis of Breast-Q patient-reported outcomes.

OBJECTIVE: Breast reconstruction following mastectomy can increase the quality of life of patients. Reconstruction methods can broadly be divided into implant-based and autologous tissue reconstruction. Patient-reported outcomes following breast reconstruction are one of the most important success parameters. In this systematic review and meta-analysis, we aimed to compare the two methods using the recognized Breast-Q questionnaire. METHODS: We performed a systematic search in PubMed and EMBASE databases. Meta-analysis was performed on the five most commonly reported Breast-Q modules. RevMan 5.3 was used for statistical analysis. Methodological quality of the included studies was assessed using the Newcastle-Ottawa Quality Assessment Form for Cohort Studies. RESULTS: The search strategy resulted in 219 studies of which nine studies were included in the analysis, yielding 2129 implant-based and 825 autologous breast reconstructions. Overall satisfaction with outcome as well as breast was significantly higher among patients with autologous breast reconstructions (mean Breast-Q difference between the two groups was 9.82 [3.09, 16.54], p = 0.004, and 10.33 [95% CI 5.93, 14.74], p<0.00001, respectively). Sexual and psychosocial well-being was higher among autologous breast reconstructions. There was no difference in the physical well-being. CONCLUSION: This is the first systematic review and meta-analysis to compare patient-reported outcomes of implant-based and autologous breast reconstruction. We found that autologous reconstruction yields a higher satisfaction with overall outcome and breast. These findings can aid clinicians when discussing breast reconstruction options with patients.

Submental Island Flap versus Free Flap Reconstruction for Complex Head and Neck Defects.

OBJECTIVE: Complex soft tissue reconstruction of the head and neck requires a viable, versatile, and dependable flap. Free flaps, such as the radial forearm and anterolateral thigh flap, have been the mainstay of complex head and neck reconstruction. However, a local pedicled flap, such as the submental island flap (SIF), could be a more effective and less demanding alternative. This systematic review and meta-analysis aim to compare free tissue transfer (FTT) with the SIF for head and neck reconstruction. DATA SOURCES: We performed a systematic search in PubMed and EMBASE databases. Meta-analysis was performed on outcomes reported in ≥3 studies. REVIEW METHODS: Candidate articles were assessed for eligibility by 2 authors. Three authors performed data extraction and methodological quality of the included studies using the Newcastle-Ottawa Quality Assessment Form for Cohort Studies. RESULTS: The search strategy resulted in 450 studies, of which 7 were included in the analysis, yielding 155 SIF and 198 FTT cases. Operating time and length of stay were significantly lower for the SIF than for FTT (P = .05 and P = .0008). There was no significant difference between the groups for complete flap loss, debulking revisions, and oncologic recurrence. CONCLUSION: These results suggest that the SIF reduces length of stay and operating time as compared with FTT in head and neck reconstruction. These findings suggest that the SIF can be considered an alternative reconstructive option to FTT when evaluating intraoral, lateral facial, skull base, and parotidectomy defects, given comparable defect size and tumor biology.

Prophylactic incisional negative pressure wound therapy shows promising results in prevention of wound complications following inguinal lymph node dissection for Melanoma: A retrospective case-control series.

BACKGROUND: Inguinal lymphadenectomy (ILND) for melanoma is associated with a number of complications including seroma, surgical site infection (SSI), and lymphedema. Incisional negative pressure wound therapy (iNPWT) has shown promising results in preventing postoperative morbidity across a wide variety of surgical procedures, but these results are yet to be investigated in patients undergoing ILND for melanoma. METHODS: In this study, we reviewed the data of 55 melanoma patients treated with ILND between January 2015 and January 2017 at Odense University Hospital. Patients were followed up until April 2018 for the occurrence of seroma, SSI, and lymphedema. We used prophylactic iNPWT after ILND in 14 patients and compared their morbidity outcomes with the 41 patients receiving standard postoperative wound care in the same period. RESULTS: The iNPWT intervention significantly reduced seroma compared to the control group (28.6% vs. 90.3%, p < 0.001) and had a trending impact on wound infection (42.9% vs. 65.9%, p = 0.13). The effect was not significant for the prevention of lymphedema (35.7% vs. 51.2%, p = 0.33). Because the iNPWT group had relatively fewer incidences of seroma, SSI, and lymphedema, the iNPWT intervention was more cost-effective than conventional wound care (US$911.2 vs. US$2542.7, p < 0.05). CONCLUSION: The use of prophylactic iNPWT significantly reduced seroma formation following ILND. These promising results, however, need to be confirmed in a future prospective randomized trial.

Correction to: Prevention of seroma following inguinal lymph node dissection with prophylactic, incisional, negative-pressure wound therapy (SEROMA trial): study protocol for a randomized controlled trial.

Following publication of the original article [1], the authors reported that one of the authors' names is spelled incorrectly. In this Correction the incorrect and correct author name are shown. The original publication of this article has been corrected.

Prevention of seroma following inguinal lymph node dissection with prophylactic, incisional, negative-pressure wound therapy (SEROMA trial): study protocol for a randomized controlled trial.

BACKGROUND: Radical inguinal lymphadenectomy (ILND) for metastatic melanoma is associated with a high complication rate. Seroma is often the first postoperative complication, followed by prolonged wound healing sometimes requiring reoperation, infection, multiple outpatient visits and re-hospitalization. Prevention of seroma may, therefore, lead to a reduction in many of the other complications. METHODS/DESIGN: The primary aim of this randomized study is to investigate whether fewer patients require treatment for seroma by immediate prophylactic application of incisional, Negative-pressure Wound Therapy (iNPWT) following ILND, compared to standard postoperative treatment. The secondary outcomes include surgical-site infection, dehiscence, hematoma, length of hospitalization, quality of life, safety, long-term assessment of lymphedema and non-inferiority oncological outcome. Data will be registered prospectively at check-ups after 7 and 14 days, 1 and 3 months and 2 years after inguinal lymphadenectomy using case report forms and questionnaires and stored in a secure online database. DISCUSSION: To our knowledge, this trial is the first randomized study evaluating negative-pressure wound therapy as a prophylactic intervention for complications following melanoma-related ILND. The results from this trial will hopefully determine the efficacy and safety of prophylactic iNPWT treatment in prevention of the clinical relevant short- and long-term postoperative complications following ILND and may provide an evidence base for the an improved postoperative regimen. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT03433937 . Prospectively registered on 15 February 2018.