The QUILT study: quilting sutures in patients undergoing breast cancer surgery: a stepped wedge cluster randomized trial study.

Autor: Zeelst LJV; Department of Surgical Oncology, Canisius Wilhelmina Hospital, Weg Door Jonkerbos 100, 6532 SZ, Nijmegen, The Netherlands. l.vanzeelst@cwz.nl., Ten Wolde B; Department of Surgical Oncology, Canisius Wilhelmina Hospital, Weg Door Jonkerbos 100, 6532 SZ, Nijmegen, The Netherlands., Plate JDJ; Department of Surgical Oncology, Canisius Wilhelmina Hospital, Weg Door Jonkerbos 100, 6532 SZ, Nijmegen, The Netherlands., Volders JH; Department of Surgical Oncology, Diakonessenhuis, Bosboomstraat 1, 3582 KE, Utrecht, The Netherlands., van Eekeren RRJP; Department of Surgical Oncology, Rijnstate Hospital, Wagnerlaan 55, 6815 AD, Arnhem, The Netherlands., Doeksen A; Department of Surgical Oncology, St. Antonius Hospital, Soestwetering 1, 3543 AZ, Nieuwegein, Netherlands., Hoven-Gondrie ML; Deparment of Surgical Oncology, Hospital Gelderse Vallei, Willy Brandtlaan 10, 6716 RP, Ede, Netherlands., Olieman AFT; Department of Surgical Oncology, Martini Hospital, Van Swietenplein 1, 9728 NT, Groningen, Netherlands., van Riet YEA; Department of Surgical Oncology, Catharina Hospital, Michelangelolaan 2, 5623 EJ, Eindhoven, Netherlands., van der Velden APS; Department of Surgical Oncology, St. Jansdal Hospital, Wethouder Jansenlaan 90, 3844 DG, Harderwijk, Netherlands., Vijfhuize S; Deparment of Surgical Oncology, Bravis Hospital, Boerhaavelaan 25, 4708 AE, Roosendaal, Netherlands., Witjes HHG; Department of Surgical Oncology, Onze Lieve Vrouwe Gasthuis, Jan Tooropstraat 164, 1061 AE, Amsterdam, Netherlands., de Wilt JHW; Radboudumc Department of Surgical Oncology, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen, Netherlands., Strobbe LJA; Department of Surgical Oncology, Canisius Wilhelmina Hospital, Weg Door Jonkerbos 100, 6532 SZ, Nijmegen, The Netherlands.
Jazyk: angličtina
Zdroj: BMC cancer [BMC Cancer] 2023 Jul 17; Vol. 23 (1), pp. 667. Date of Electronic Publication: 2023 Jul 17.
DOI: 10.1186/s12885-023-11154-0
Abstrakt: Background: Seroma is the most common complication following breast cancer surgery, with reported incidence up to 90%. Seroma causes patient discomfort, is associated with surgical site infections (SSI), often requires treatment and increases healthcare consumption. The quilting suture technique, in which the skin flaps are sutured to the pectoralis muscle, leads to a significant reduction of seroma with a decrease in the number of aspirations and surgical site infections. However, implementation is lagging due to unknown side effects, increase in operation time and cost effectiveness. Main objective of this study is to assess the impact of large scale implementation of the quilting suture technique in patients undergoing mastectomy and/or axillary lymph node dissection (ALND).
Methods: The QUILT study is a stepped wedge design study performed among nine teaching hospitals in the Netherlands. The study consists of nine steps, with each step one hospital will implement the quilting suture technique. Allocation of the order of implementation will be randomization-based. Primary outcome is 'textbook outcome', i.e.no wound complications, no re-admission, re-operation or unscheduled visit to the outpatient clinic and no increased use of postoperative analgesics. A total of 113 patients is required based on a sample size calculation. Secondary outcomes are shoulder function, cosmetic outcome, satisfaction with thoracic wall and health care consumption. Follow-up lasts for 6 months.
Discussion: This will be one of the first multicentre prospective studies in which quilting without postoperative wound drain is compared with conventional wound closure. We hypothesize that quilting is a simple technique to increase textbook outcome, enhance patient comfort and reduce health care consumption.
(© 2023. The Author(s).)
Databáze: MEDLINE
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