{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,10]],"date-time":"2026-10-10T17:44:42Z","timestamp":1791654282669,"version":"4.3.4"},"reference-count":35,"publisher":"BMJ","issue":"4","content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2015,10,21]]},"published-print":{"date-parts":[[2016,4]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>\n                      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\u2005days 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 \u03c7\n                      <jats:sup>2<\/jats:sup>\n                      test (or Fisher's exact test).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>Written informed consent will be obtained from all participants. This study was approved by Tours Research ethics committee (CPP TOURS\u2014Region Centre\u2014Ouest 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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>NCT02263651.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2015-009903","type":"journal-article","created":{"date-parts":[[2016,4,4]],"date-time":"2016-04-04T20:58:14Z","timestamp":1459803494000},"page":"e009903","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":34,"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"],"prefix":"10.1136","volume":"6","author":[{"given":"Lobna","family":"Ouldamer","sequence":"first","affiliation":[{"name":"Department of Gynecology, CHRU de Tours, Tours, France"},{"name":"INSERM unit 1069, Tours, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Julia","family":"Bonastre","sequence":"additional","affiliation":[{"name":"Gustave Roussy, Service de Biostatistique et d'Epidemiologie, Villejuif, France"},{"name":"CESP, Centre for Research in Epidemiology and Population Health, Villejuif, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sol\u00e8ne","family":"Brunet-Houdard","sequence":"additional","affiliation":[{"name":"Universit\u00e9 Fran\u00e7ois-Rabelais de Tours, PRES Centre-Val de Loire Universit\u00e9, Tours, France"},{"name":"CHRU de Tours, Unit\u00e9 d'Evaluation M\u00e9dico-Economique, Tours, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gilles","family":"Body","sequence":"additional","affiliation":[{"name":"Department of Gynecology, CHRU de Tours, Tours, France"},{"name":"Universit\u00e9 Fran\u00e7ois-Rabelais de Tours, PRES Centre-Val de Loire Universit\u00e9, Tours, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bruno","family":"Giraudeau","sequence":"additional","affiliation":[{"name":"Universit\u00e9 Fran\u00e7ois-Rabelais de Tours, PRES Centre-Val de Loire Universit\u00e9, Tours, France"},{"name":"CHRU de Tours, Tours, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Agn\u00e8s","family":"Caille","sequence":"additional","affiliation":[{"name":"Universit\u00e9 Fran\u00e7ois-Rabelais de Tours, PRES Centre-Val de Loire Universit\u00e9, Tours, France"},{"name":"CHRU de Tours, Tours, France"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2016,4,4]]},"reference":[{"key":"2025121407075249000_6.4.e009903.1","unstructured":"HCL, Invs, INCa, Francim, Inserm. 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