Journal Article

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

Olieman, A. F. T., ten Wolde, B., Vijfhuize, S., de Wilt, J. H. W., Volders, J. H., Doeksen, A., Hoven-Gondrie, M. L., van der Velden, A. P. Schouten, Zeelst, L. J. van, van Riet, Y. E. A., Plate, J. D. J., Witjes, H. H. G., van Eekeren, R.R.J.P., Strobbe, L. J. A.

2023

Overview

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.

• Publisher: BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
• Subject: Analgesics / Biomedical and Life Sciences / Biomedicine / Breast cancer / Breast cancer surgery / Breast Neoplasms - complications / Cancer / Cancer patients / Cancer Research / Cancer surgery / Care and treatment / Clinics / Complications / Complications and side effects / Diagnosis / Dissection / Drainage - methods / Female / Flap fixation / Health aspects / Health care / Health care policy / Health Promotion and Disease Prevention / Hospitals / Humans / Infection / Lymph nodes / Lymphatic system / Mastectomy / Mastectomy - adverse effects / Mastectomy - methods / Medicine/Public Health / Methods / Oncology / Oncology, Experimental / Outpatient care facilities / Pain / Participation / Patients / Postoperative Complications - epidemiology / Postoperative Complications - etiology / Prospective Studies / Questionnaires / Quilting / Seroma / Seroma - etiology / Study Protocol / Surgeons / Surgery / Surgical Oncology / Surgical site infections / Surgical Wound Infection - etiology / Sutures / Sutures - adverse effects / Thorax / Wound healing