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Efficacy and aesthetic outcomes for quilting sutures in the prevention of seroma after mastectomy.

ABSTRACT: Worldwide, mastectomy for breast cancer is one of the most frequently performed surgical procedures. As one of the main complications of mastectomy, seroma is associated with pain, infections and a prolonged hospital stay. We performed a prospective multicenter randomized trial to assess the efficacy and esthetic outcomes associated with quilting the skin flap. Eighty-seven patients were included. The proportion of patients with seroma on postoperative day 15 was significantly lower in the quilting group (12 out of 39 (30.8%)) than in a control group with conventional wound closure (21 out of 40 (52.5%); P = 0.05). The mean breast seroma volume was significantly lower in the quilting group (130.2 mL) than in the control group (236.8 mL; P = 0.02). There were no differences in the esthetic outcomes. The pain level on day 1 was similar in the quilting and control groups (mean visual analog scale score: 2.5 vs. 2.1, respectively; P = 0.3). Quilting the skin flap was associated with a lower prevalence of seroma and a lower seroma volume, and did not worsen the esthetic outcomes or pain levels. This technique is technically straightforward and should be offered to all patients scheduled for mastectomy.

SUBMITTER: Foulon A

PROVIDER: S-EPMC9894844 | biostudies-literature | 2023 Feb

REPOSITORIES: biostudies-literature

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Efficacy and aesthetic outcomes for quilting sutures in the prevention of seroma after mastectomy.

Foulon Arthur A Mancaux Albine A Theret Pierrick P Naepels Philippe P Mychaluk Johanna J Merviel Philippe P Abboud Pascal P Fauvet Raffaele R

Scientific reports 20230202 1

Worldwide, mastectomy for breast cancer is one of the most frequently performed surgical procedures. As one of the main complications of mastectomy, seroma is associated with pain, infections and a prolonged hospital stay. We performed a prospective multicenter randomized trial to assess the efficacy and esthetic outcomes associated with quilting the skin flap. Eighty-seven patients were included. The proportion of patients with seroma on postoperative day 15 was significantly lower in the quilt ...[more]

PMID: 36732364

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Project description:BACKGROUND:Seroma formation is a common complication after mastectomy and is associated with delayed wound healing, infection, skin flap necrosis, patient discomfort and repeated visits to the out patient clinic to deal with seroma and its sequelae. Closing the dead space after mastectomy seems to be key in reducing seroma and its complications. Various methods have been described to reduce the dead space after mastectomy: closed suction drainage, quilting of the skin flaps and application of adhesive tissue glues. The aim of this trial is to compare seroma formation and its sequelae in the various methods of flap fixation. METHODS:This is a multicenter, double-blind, randomized controlled trial in female breast cancer patients undergoing mastectomy, with or without axillary clearance. Exclusion criteria consist of breast conserving therapy, direct breast reconstruction and incapacity to comprehend implications and extent of study and unable to sign for informed consent. A total of 336 patients will be randomized. Patients will be randomly allocated to one of three treatment arms consisting of flap fixation using ARTISS tissue glue with a low suction drain, flap fixation using sutures and a low suction drain or conventional wound closure (without flap fixation) and low suction drainage. Follow up will be conducted up to twelve months post surgery. The primary outcome is the number of seroma aspirations and secondary outcomes consist of number of out patient clinic visits, surgical skin infection rate, shoulder function, cosmesis, health-related quality of life and costs and cost-effectiveness (cost/QALY). DISCUSSION:This is the first study of its kind to evaluate the effect of flap fixation and its sequelae (ie seroma aspirations, number of out patient clinic visits, infection, shoulder function, patient assessed cosmesis, quality of life and cost-effectiveness) in a double blind randomized controlled trial. TRIAL REGISTRATION:This trial was approved by the hospitals' joint medical ethical committee (14-T-21, 2 June 2014). The SAM Trial is registered in ClinicalTrials.gov since October 2017, Identifier: NCT03305757 .

Project description:BackgroundNipple-sparing mastectomy (NSM) followed by immediate breast reconstruction (IBR) is the optimal surgical treatment for breast cancer. However, investigations are ongoing to improve the surgical technique to achieve better results. This study aimed to evaluate the outcomes of modified NSM (m-NSM), which preserves the anterior lamellar fat layer, in patients who underwent IBR.MethodsAll patients who underwent modified NSM (m-NSM) or conventional NSM (c-NSM) followed by IBR using autologous tissue or implants were retrospectively reviewed between January 2014 and January 2021. Two mastectomy types were compared in terms of postoperative complications and aesthetic outcomes using panel assessment scores by physicians and reported outcomes using Breast-Q. In addition, postoperative evaluations of the thickness of mastectomy flap was performed using CT scan images.ResultsA total of 516 patients (580 breasts) with NSM (143 breasts with c-NSM and 437 breasts with m-NSM) followed by IBR were reviewed. The mean ± SD flap thickness was 8.48 ± 1.81 mm in patients who underwent m-NSM, while it was 6.32 ± 1.15 mm in the c-NSM cohort (p = 0.02). The overall major complications rate was lower in the m-NSM group (3.0% vs. 9.0%, p < 0.013). Ischemic complications of the mastectomy flap and nipple-areolar complex (NAC) were more in c-NSM, although the difference was not statistically significant. The mean panel assessment scores were higher in the m-NSM group (3.14 (good) and 2.38 (fair) in the m-NSM and c-NSM groups, respectively; p < 0.001). Moreover, m-NSM was associated with greater improvements in psychosocial (p < 0.001) and sexual (p = 0.007) well-being.ConclusionPreserving the anterior lamellar fat in NSM was associated with thicker mastectomy flap, overall lower rates of complications, including ischemia of the mastectomy flap and nipple-areolar complex, and was associated with better aesthetic outcomes and improved quality of life.

Project description:BackgroundSeroma formation is a common complication after breast cancer surgery and can lead to delayed wound healing, infection, patient discomfort and repeated visits to the outpatient clinic. Mastectomy combined with flap fixation is becoming standard practice and is currently combined with closed-suction drainage. There is evidence showing that closed-suction drainage may be insufficient in preventing seroma formation. There is reasonable doubt whether there is still place for closed-suction drainage after mastectomy when flap fixation is performed. We hypothesize that mastectomy combined with flap fixation and closed suction drainage does not cause a significant lower incidence of seroma aspirations, when compared to mastectomy and flap fixation alone. Furthermore, we expect that patients without drainage will experience significantly less discomfort and comparable rates of surgical site infections.MethodsThis is a randomized controlled trial in female breast cancer patients undergoing mastectomy and flap fixation using sutures with or without sentinel lymph node biopsy (SLNB). Patients will be eligible for inclusion if they are older than 18 years, have an indication for mastectomy with or without sentinel procedure. Exclusion criteria are modified radical mastectomy, direct breast reconstruction, previous history of radiation therapy of the unilateral breast, breast conserving therapy and inability to give informed consent. A total of 250 patients will be randomly allocated to one of two groups: mastectomy combined with flap fixation and closed-suction drainage or mastectomy combined with flap fixation without drainage. Follow-up will be conducted up to six months postoperatively. The primary outcome is the proportion of patients undergoing one or more seroma aspirations. Secondary outcome measures consist of the number of invasive interventions, surgical site infection, quality of life measured using the SF-12 Health Survey, cosmesis, pain and number of additional outpatient department visits.DiscussionTo our knowledge, no randomized controlled trial has been conducted comparing flap fixation with and without closed-suction drainage with seroma aspiration as the primary outcome. This study could result in finding evidence that supports performing mastectomy without closed-suction drainage.Trial registrationThis trial was approved by the medical ethical committee of Zuyderland Medical Center METC-Z on 20 March 2019 (METCZ20190023). The SARA Trial was registered at ClinicalTrials.gov as per July 2019, Identifier: NCT04035590 .

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Efficacy and aesthetic outcomes for quilting sutures in the prevention of seroma after mastectomy.

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Efficacy and aesthetic outcomes for quilting sutures in the prevention of seroma after mastectomy.

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