title: Dead space closure with quilting suture versus conventional closure with drainage for the prevention of seroma after mastectomy for breast cancer (QUISERMAS): protocol for a multicentre randomised controlled trial.
abstract: BACKGROUND
  Postoperative wound seroma is common after mastectomy. This complication is associated with significant impact on patient outcomes and healthcare costs. The optimal closure approach for seroma prevention remains unknown but some evidence suggests that quilting suture of the dead space could lower the incidence of seroma. The aim of this trial is to compare seroma formation using quilting suture versus conventional closure with drainage in patients undergoing mastectomy.
  
  
  METHODS
  This is a multicentre, superiority, randomised controlled trial in women undergoing mastectomy with or without axillary involvement. Exclusion criteria include indication of bilateral mastectomy or immediate reconstruction and any physical or psychiatric condition that could impair patient's ability to cooperate with postoperative data collection or that do not allow an informed consent. 320 participants will be randomised in a 1:1 ratio to receive either quilting suture or conventional wound closure with drain. The primary outcome is seroma requiring either aspiration or surgical intervention within 21 days following mastectomy. Secondary outcomes include seroma regardless of whether or not it requires an intervention, surgical site infection, pain score, cosmetic result, patient's quality of life, costs and cost-effectiveness. The primary analysis will be an intention-to treat analysis performed with a χ(2) test (or Fisher's exact test).
  
  
  BACKGROUND
  Written informed consent will be obtained from all participants. This study was approved by Tours Research ethics committee (CPP TOURS-Region Centre-Ouest 1, 2014-R20, 16 December 2014). Study findings will be published in peer-reviewed journals and presented at relevant national and international breast cancer conferences.
  
  
  BACKGROUND
  NCT02263651.
authors.affiliation: Department of Gynecology, CHRU de Tours, Tours, France INSERM unit 1069, Tours, France.
authors.forename: Lobna
authors.initials: L
authors.lastname: Ouldamer
authors.affiliation: Gustave Roussy, Service de Biostatistique et d'Epidemiologie, Villejuif, France CESP, Centre for Research in Epidemiology and Population Health, Villejuif, France.
authors.forename: Julia
authors.initials: J
authors.lastname: Bonastre
authors.affiliation: Université François-Rabelais de Tours, PRES Centre-Val de Loire Université, Tours, France CHRU de Tours, Unité d'Evaluation Médico-Economique, Tours, France.
authors.forename: Solène
authors.initials: S
authors.lastname: Brunet-Houdard
authors.affiliation: Department of Gynecology, CHRU de Tours, Tours, France Université François-Rabelais de Tours, PRES Centre-Val de Loire Université, Tours, France.
authors.forename: Gilles
authors.initials: G
authors.lastname: Body
authors.affiliation: Université François-Rabelais de Tours, PRES Centre-Val de Loire Université, Tours, France CHRU de Tours, Tours, France.
authors.forename: Bruno
authors.initials: B
authors.lastname: Giraudeau
authors.affiliation: Université François-Rabelais de Tours, PRES Centre-Val de Loire Université, Tours, France CHRU de Tours, Tours, France.
authors.forename: Agnès
authors.initials: A
authors.lastname: Caille
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001365:Axilla; D001943:Breast Neoplasms / Q000601:surgery*; D002985:Clinical Protocols; D004322:Drainage / Q000379:methods*; D005260:Female; D006801:Humans; D008408:Mastectomy / Q000009:adverse effects / Q000379:methods*; D008875:Middle Aged; D011183:Postoperative Complications / Q000517:prevention & control*; D011788:Quality of Life; D049291:Seroma / Q000517:prevention & control*; D013524:Surgical Flaps; D013530:Surgical Wound Infection / Q000517:prevention & control; D013536:Suture Techniques / Q000009:adverse effects; D013537:Sutures / Q000009:adverse effects; D055815:Young Adult