Comparison of ‘quilting sutures’ with ‘conventional sutures and drain placement’ after mastectomy: protocol for the BE-Quilt – a multicentre, pragmatic randomised controlled trial

Introduction Seroma formation is the most common complication following mastectomy, often leading to patient discomfort, delayed wound healing, impaired shoulder function, suboptimal cosmetic outcome and delayed initiation of adjuvant treatment. To prevent this, most Belgian breast centres routinely use suction drainage, despite associated disadvantages such as infection risk, discomfort and negative impact on postoperative rehabilitation. Quilting sutures, a technique that minimises dead space after surgery by fixation of the skin flaps to the underlying muscle, have been well established to significantly reduce the risk of seroma formation. Nevertheless, despite being technically straightforward and recommended for routine use in patients undergoing mastectomy, quilting remains largely absent from standard clinical practice. This may be explained by concerns regarding its potential impact on functional outcomes and quality of life, as well as limited experience and confidence with the technique among surgeons. The BE-Quilt trial therefore aims to assess whether quilting sutures without drain placement are non-inferior to conventional sutures with drain placement in patients undergoing mastectomy, in terms of patient-reported functional and quality-of-life outcomes at 6 months post-surgery. Methods and analysis A multicentre, pragmatic randomised controlled trial, conducted from 1-month pre-surgery to 6 months post-surgery, will include 296 patients scheduled for unilateral mastectomy without immediate reconstruction, with or without axillary surgery. Competitive recruitment will be performed across 14 Belgian hospitals over 24 months, with participants randomised in a 1:1 ratio. The primary aim is to assess whether the quilting technique is non-inferior to the standard approach of closing the mastectomy wound regarding patient-reported functional and quality-of-life outcomes at 6 months post-surgery. These outcomes include subjective upper limb function, scored by QuickDASH, and cosmetic outcome and pain in the mastectomy area, both scored by using a Visual Analogue Scale. Secondary endpoints include the same outcomes assessed at additional time points (10 days and 3 weeks post-surgery, with daily pain assessments from day 1–10 and questions regarding chronic pain at 6 months), as well as clinical parameters evaluated throughout follow-up, such as seroma formation and wound complications, along with both mastectomy-related and general health-related quality of life, scored by Breast-Q and EuroQol 5-Dimension 5-Level, a validated instrument for measuring health-related quality of life (EQ-5D-5L). Healthcare consumption will also be recorded. Primary outcomes will be analysed using linear models to test non-inferiority with a prespecified margin, adjusting for study centre. Secondary continuous outcomes will be analysed using mean differences or mixed-models, as appropriate, and binary outcomes using ORs or generalised estimating equations. Analyses will be conducted in both intention-to-treat and per-protocol populations. Ethics and dissemination The protocol was approved by the Ethics Committee Research of University Hospitals Leuven (reference number S66948). This study is in progress. Modifications to the protocol will be reviewed by the Ethics Committee and implemented after approval. Data monitoring will be performed by monitors who are not involved in the study. Results will be disseminated through peer-reviewed publications and presentations at scientific conferences. Trial registration number NCT06415032.