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
2016
Ouldamer, Lobna | Bonastre, Julia | Brunet-Houdard, Solène | Body, Gilles | Giraudeau, Bruno | Caille, Agnès | Niche, Nutrition, Cancer et métabolisme oxydatif (N2Cox) ; Université de Tours (UT)-Institut National de la Santé et de la Recherche Médicale (INSERM) | Hôpital Bretonneau ; Centre Hospitalier Régional Universitaire de Tours (CHRU Tours) | Université de Tours (UT) | Service de biostatistique et d'épidémiologie (SBE) ; Direction de la recherche clinique [Gustave Roussy] ; Institut Gustave Roussy (IGR)-Institut Gustave Roussy (IGR) | Centre de recherche en épidémiologie et santé des populations (CESP) ; Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Université Paris-Sud - Paris 11 (UP11)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale (INSERM) | Department of Gynecology ; Centre Hospitalier Universitaire d'Angers (CHU Angers) ; PRES Université Nantes Angers Le Mans (UNAM)-PRES Université Nantes Angers Le Mans (UNAM) | Centre de Recherche Épidémiologie et Statistique Sorbonne Paris Cité (CRESS (U1153 / UMR_A_1125 / UMR_S_1153)) ; Institut National de la Recherche Agronomique (INRA)-Université Paris Diderot - Paris 7 (UPD7)-Université Paris Descartes - Paris 5 (UPD5)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM) | Centre d’Investigation Clinique [Tours] CIC 1415 (CIC) ; Centre Hospitalier Régional Universitaire de Tours (CHRU Tours)-Institut National de la Santé et de la Recherche Médicale (INSERM) | PRES Centre-Val de Loire Université | Centre Hospitalier Régional Universitaire de Tours (CHRU Tours) | MethodS in Patients-centered outcomes and HEalth ResEarch (SPHERE) ; Université de Tours (UT)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Nantes - UFR des Sciences Pharmaceutiques et Biologiques (UFR SPB) ; Université de Nantes (UN)-Université de Nantes (UN) | Biostatistique, Recherche Clinique et Mesures Subjectives en Santé (EA 4275) ; Université de Nantes - UFR des Sciences Pharmaceutiques et Biologiques (UFR SPB) ; Université de Nantes (UN)-Université de Nantes (UN)
International audience
显示更多 [+] 显示较少 [-]英语. INTRODUCTION: 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 AND ANALYSIS: 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\hspace0.25emdays 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). ETHICS AND DISSEMINATION: 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. TRIAL REGISTRATION NUMBER: NCT02263651.
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