IntroductionThe emphasis on aesthetic outcomes and quality of life (QoL) has motivated surgeons to develop skin-sparing or nipple-sparing mastectomy (SSM/ NSM) for breast cancer treatment or ...prevention. During the same operation, a so-called immediate breast reconstruction is performed. The breast can be reconstructed by positioning of a breast implant above (prepectoral) or below (subpectoral) the pectoralis major muscle or by using the patients’ own tissue (autologous reconstruction). The optimal positioning of the implant prepectoral or subpectoral is currently not clear. Subpectoral implant-based breast reconstruction (IBBR) is still standard care in many countries, but prepectoral IBBR is increasingly performed. This heterogeneity in breast reconstruction practice is calling for randomised clinical trials (RCTs) to guide treatment decisions.Methods and analysisInternational, pragmatic, multicentre, randomised, superiority trial. The primary objective of this trial is to test whether prepectoral IBBR provides better QoL with respect to long-term (24 months) physical well-being (chest) compared with subpectoral IBBR for patients undergoing SSM or NSM for prevention or treatment of breast cancer. Secondary objectives will compare prepectoral versus subpectoral IBBR in terms of safety, QoL and patient satisfaction, aesthetic outcomes and burden on patients. Total number of patients to be included: 372 (186 per arm).Ethics and disseminationThis study will be conducted in compliance with the Declaration of Helsinki. Ethical approval has been obtained for the lead investigator’s site by the Ethics Committee ‘Ethikkommission Nordwest- und Zentralschweiz‘ (2020–00256, 26 March 2020). The results of this study will be published in a peer-reviewed medical journal, independent of the results, following the Consolidated Standards of Reporting Trials standards for RCTs and good publication practice. Metadata describing the type, size and content of the datasets will be shared along with the study protocol and case report forms on public repositories adhering to the FAIR (Findability, Accessibility, Interoperability, and Reuse) principles.Trial registration number NCT04293146.
Background
Pectus excavatum is less common in females than in males, and it often aggravates a coexistent breast asymmetry. We conducted a study comparing female patients’ versus medical ...professionals’ evaluation of pectus excavatum repair to assess differences in aesthetic outcome ratings. Moreover, we evaluated the influence of surgical correction on patients’ self-perception.
Methods
Of 30 female patients who were initially screened, 18 patients (mean age, 20 years) who underwent bar removal after surgical correction of pectus excavatum deformity participated in the survey (60%). They completed a questionnaire rating their appearance before and after surgery and responded to a psychological questionnaire about the changes that they had experienced. The mean interval between pectus bar removal and evaluation was 28 months. Standardized preoperative and postoperative patient photographs were evaluated using the same questionnaire by a panel of medical professionals and students (n=24) and the results were compared.
Results
Patients rated their preoperative deformity as more severe than the other evaluators, revealing the significant impact of the deformity on patients’ self-perception. Postoperatively, patient and professional evaluations were much better than before and were very similar. The psychological evaluation showed a clear improvement in well-being. The ratings of the medical professionals were not influenced by their degree of medical education.
Conclusions
Surgical correction of pectus excavatum in female patients positively influences body perception and psychological well-being. It should therefore not be considered as a merely aesthetic correction, but as an important procedure to restore a patient’s self-perception.
Aim: The use of negative pressure wound therapy (NPWT) is well established in the treatment of chronic wounds. NPWT with instillation (NPWTi) combines traditional NPWT with the application of a ...topical irrigation solution (in this case octenidine based octenilin? wound irrigation solution) within the wound bed. The purpose of the study was to investigate the impact of NPWTi on pressure ulcers (PUs). Methods: In total 13 patients with PUs in different locations were treated with negative pressure therapy combined with ocitenidine based instillation fluid after first surgical debridement. After 6 days the dressing was removed and wound closure using different local flaps was performed. Results: Normal wound healing without irritation was found 30 days post-debridement and after 90 days the wounds showed complete healing. No adverse incidents occurred and no toxic tissue reactions were documented. During the follow up period, there was no recurrence of the PU in any of the treated patients. Conclusion: It is generally recognised that for chronic wounds to heal, optimum wound bed preparation is of paramount importance. This helps prepare for secondary healing, skin grafting or coverage with flaps. Tests were performed in vitro simulating real clinical conditions using PU vacuum exudates. These tests quantified the antiseptic efficacy of octenilin? wound irrigation solution in the eradication of microorganisms. Further research is needed to establish the role of NPWTi with octenilin? in the management of category 4 PUs, but these initial results on 13 patients lead in the direction of developing an enhanced protocol for the treatment of chronic wounds.
Background
A persistent problem in autologous breast reconstruction in skin-sparing mastectomies is skin restoration after skin necrosis or secondary oncological resection. As a solution to ...facilitate reconstruction, skin banking of free-flap skin has been proposed in cases where the overlying skin envelope must be resected, as this technique spares the patient an additional donor site. Herein, we present the largest series to date in which this method was used. We investigated its safety and the possibility of skin banking for prolonged periods of time.
Methods
All skin-sparing mastectomies and immediate autologous breast reconstructions from December 2009 until June 2013 at our institution were analysed.
Results
We identified 31 patients who underwent 33 free flap reconstructions in which skin banking was performed. Our median skin banking period was 7 days, with a maximum duration of 171 days. In 22.5% of cases, the banked skin was used to reconstruct overlying skin defects, and in 9.6% of cases to reconstruct the nipple-areolar complex. Microbiological and histological investigations of the banked skin revealed neither clinical infections nor malignancies.
Conclusions
In situ
skin banking, even for prolonged periods of time, is a safe and cost-effective method to ensure that skin defects due to necrosis or secondary oncological resection can be easily reconstructed.
Fat grafting is a well‐established method in plastic surgery. Despite many technical advances, standardised recommendations for the use of prophylactic antibiotics in fat grafting are not available. ...This retrospective multicentre study aims to analyse the use of prophylactic antibiotics in fat grafting and to compare complication rates for different protocols. A retrospective medical chart review of 340 patients treated with fat grafting of the breast from January 2007 to March 2019 was performed in three plastic surgery centres. Complications, outcomes, and antibiotic regimes were analysed. The Clavien‐Dindo classification was applied. All patients received perioperative antibiotic prophylaxis: 33.8% (n = 115) were treated with a single shot (group 1), 66.2% (n = 225) received a prolonged antibiotic scheme (group 2). There was no significant difference in the number of sessions (P = .475). The overall complication rate was 21.6% (n = 75), including graft resorption, fat necrosis, infection, and wound healing problems. Complication rates were not significantly different between groups. Risk factors for elevated complication rates in this specific patient group are smoking, chemotherapy, and irradiation therapy. The complication rate for lipografting of the breast is low, and it is not correlated to the antibiotic protocol. The use of prolonged prophylactic antibiotics does not lower the complication rate.
Body contouring surgery following massive weight loss is often prone to complications. Subcutaneous adipose tissue is a rich source of stromal vascular fraction (SVF) cells, and moreover it plays an ...important role in the pathophysiology of obesity, metabolic syndrome, and wound healing. In this retrospective, single‐centred appraisal, complications are examined and correlated with individual SVF numbers in abdominal subcutaneous fat tissue. We analysed whether the weight loss method affected complications. Eighty seven massive weight loss patients undergoing body contouring surgery between 2010 and 2017 were included in the study. In total, 57 cases with at least one complication were recorded (65.5%). Maximum lifetime weight was 109.6 kg (range 48‐184 kg). Half of the complications (50.8%) were minor complications without the need for surgical revision. The mean number of SVF found in the resected tissue was 714 997.63 cells/g fat tissue. We found no statistical difference in complication rates dependent on cell numbers. Smoking (P = .049) and a high BMI at the time point of surgery (P = .031) led to significantly more complications. Also, a high resection weight (P = .057) showed a tendency for impaired wound healing. However, there was no difference in complication rates following body contouring procedures attributable to the method of weight loss in this study.
Abstract
Background The emphasis on aesthetic outcomes and quality of life (QoL) has motivated surgeons to develop skin- and nipple-sparing mastectomy (SSM/NSM) for breast cancer (BC) treatment or ...prevention. Immediate breast reconstruction is based on implants or autologous tissue. The optimal positioning of the implant is not clear: While pre-pectoral positioning respects the anatomic position of the mammary gland and avoids surgery-induced alterations of the pectoralis major muscle, the lack of muscle coverage may increase the risk of additional surgical interventions due to major complications. The Oncoplastic Breast Consortium (OPBC) identified this knowledge gap as research priority in 2019.
Trial design International, multicenter study with a superiority trial design and two parallel groups with 1:1 random allocation to pre- or sub-pectoral implant-based breast reconstruction (IBBR). Following a pragmatic approach, randomly assigned IBBR will be performed according to the surgeons’ usual care by use of a one- or two-stage approach with or without adjunctive mesh. Follow-up visits are performed within routine care (visits at 10 days and at 1, 6, 12, 18 and 24 months after surgery). Oncological follow-up will be conducted annually for 10 years. ClinicalTrials.gov identifier: NCT04293146.
Eligibility We include women ≥ 18 years, with an indication for NSM or SSM and IBBR in the therapeutic or risk-reducing setting, the ability to complete QoL questionnaires and the adequateness of skin flap(s) for pre-pectoral IBBR (intraoperative decision of the surgeon).
Specific aims The primary objective is to test whether pre-pectoral IBBR provides better QoL with respect to long-term (24 months) physical well-being of the chest (BREAST-Q) compared to sub-pectoral IBBR for patients undergoing SSM or NSM for prevention or treatment of BC. Secondary endpoints include loss of expander or implant, complications, other BREAST-Q QoL and patient satisfaction domains, aesthetic outcomes and recurrence free survival. Interference of different dose distributions of radiation therapy and its consequences on the distribution of local tumor recurrences will be assessed.
Statistical methods The primary analysis will be performed on the full analysis set following the intention-to-treat principle. To test the primary hypothesis, a linear mixed model will be fitted with the BREAST-Q score as response variable and treatment assignment as independent variable. The analysis will be adjusted for baseline BREAST-Q score, stratification factors (i.e. uni- vs bilateral surgery and NSM vs SSM) and other potential confounders. A random intercept to account for the center effect will be included. As a sensitivity analysis, an unadjusted t-test will be performed on the BREAST-Q score change from baseline to compare the two treatment arms. The sample size was determined for the primary endpoint, with an expected mean score of 76 points for sub-pectoral and 80 points for pre-pectoral implants. The clinically relevant difference to be detected in this superiority design is 4 points, with an expected common standard deviation of 13 points. A sample size of 334 patients provides an 80% power for a two-sided t-test at level α = 0.05. Compensating for a 10% dropout rate, the total sample size was calculated to include 372 patients.
Present accrual and target accrual By June 2020, one study site (Basel) has been initiated. During a 21-month recruitment period, we plan to include 372 patients at 21 sites in Switzerland, USA, China, Austria, Germany, Hungary and Sweden.
Contact information Prof. Dr. Walter Paul Weber, Chefarzt Brustchirurgie, Breast Surgeon SSO, Universitätsspital Basel, Spitalstrasse 21, CH-4031 Basel, Tel: +41 61 328 61 49, Walter.Weber@usb.ch
Citation Format: Walter Paul Weber, Elisabeth A Kappos, Meredith M Regan, Giusi Moffa, Yves Harder, Karin Ribi, Shelley Potter, Andrea Pusic, Mathias K Fehr, Lars G Hemkens, Thomas Holzbach, Jian Farhadi, Colin Simonson, Michael Knauer, Ralph Verstappen, Heiner Bucher, Daniel Zwahlen, Frank Zimmermann, Matthias Schwenkglenks, Rosine Mucklow, Vesna Bjelic-Radisic, Amelia Chiorescu, Yoon Chun, Subrina Farah, Xiasong Chen, Linda Nigard, Sherko Kümmel, Roland Reitsamer, Maik Hauschild, Ilario Fulco, Christoph Tausch, Thomas Fischer, Dimitri Sarlos, Mihai Constantinescu, Judith E Lupatsch, Florian Fitzal, Joerg Heil, Zoltán Mátrai, Jana de Boniface, Christian Kurzeder, Martin Haug, Alexandra Schulz. Pre- versus sub-pectoral implant-based breast reconstruction after skin-sparing mastectomy or nipple-sparing mastectomy (OPBC-02 PREPEC): A pragmatic, multicenter, randomized, superiority trial abstract. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr OT-23-03.
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