Quilt technique after mastectomy: stepped-wedge randomized cluster trial showing superior textbook outcome and reduced healthcare utilization

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INTRODUCTION: The quilt technique to minimize post-mastectomy seroma has been adopted slowly due to concerns about potential long-term side effects, longer operating times, and cost-effectiveness. This study aimed to evaluate the implementation of the quilt technique on textbook outcome in patients undergoing mastectomy. METHODS: A stepped-wedge randomized cluster trial was conducted in 12 Dutch hospitals, each representing a cluster. Patients who underwent the quilt technique after mastectomy were compared with those with conventional closure. Primary outcome was textbook outcome, defined as the absence of wound complications, readmissions, reoperations, or unscheduled outpatient visits, and no increase in pain medication use 6 months after surgery compared to preoperative use. Secondary outcomes were related to healthcare consumption and patient satisfaction. RESULTS: Two hundred and fifty-one patients who underwent mastectomy were included. The incidence of textbook outcome was higher in the quilted cohort compared to the non-quilted cohort, 94 of 143 (65.7%) versus 26 of 63 patients (41.3%, P = 0.003). Wound complications, including clinically significant seroma, were 24.0% in the quilted patients versus 55.6% in the non-quilted patients (P < 0.001). In the quilted cohort, 30.2% of patients required an unscheduled outpatient clinic visit, compared to 44.4% in the non-quilted cohort (P = 0.048). No significant differences were observed in postoperative pain, shoulder function, satisfaction and physical well-being of the chest, or cosmetic outcome. CONCLUSION: Quilting after mastectomy was superior to conventional closure in terms of textbook outcome and healthcare consumption without any undesirable side effects. TRIAL REGISTRATION NUMBER: NCT05272904, ClinicalTrials.gov.

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