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

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.

Omitting Postoperative Wound Drainage After Mastectomy With Skin-Flap Quilting.

BACKGROUND: Seroma is the most frequent complication after mastectomy (ME) and axillary lymph node dissection (ALND). The quilting suture technique, in which skin flaps are sutured to the underlying muscle, was previously investigated and found to reduce seroma incidence after ME and ALND. This study aimed to investigate whether postoperative wound drainage can safely be omitted when quilting sutures are applied. METHODS: Two groups with a total of 251 consecutive patients who underwent ME, ALND, or both were retrospectively compared. The first group underwent quilting sutures with wound vacuum drainage, and the second group underwent quilting sutures without wound drainage. The primary outcome was the incidence of postoperative clinically significant seroma (CSS). The secondary outcomes were the incidence of postoperative infection, bleeding complications, wound dehiscence, and flap necrosis. RESULTS: The group without a postoperative drain (n = 166) had a significantly lower CSS incidence (8.4%) than the group with a postoperative drain (n = 85, 21.2%) (p < 0.05). In the multivariate analysis, no significant predictors were found for seroma formation. Wound complications significantly decreased, from 31.8% in the group with a drain group to 17.5% in the group without a drain (p < 0.05). CONCLUSION: This study showed that the postoperative drain can be omitted when quilting sutures are applied in ME, ALND, or both. This facilitates day care mastectomy, eliminating drain-related care, discomfort, and related expenses.

Short term safety of oncoplastic breast conserving surgery for larger tumors.

BACKGROUND: Oncoplastic surgery (OPS) replaces lumpectomy as standard technique in breast conserving surgery (BCS). OPS has shown to give good cosmetic results, but is it as safe as standard lumpectomy? We conducted a retrospective cohort study to determine postoperative complications, resection margins and re-excision rates for OPS compared to standard lumpectomy. METHODS: Based on data from the 'Netherlands Cancer Registry' and medical records we scored patient, treatment and follow-up related variables. All consecutive patients, with an initially breast conserving operation for primary breast cancer, performed between January 2010 and December 2014 in a dedicated breast center were eligible. Breast surgeons performed the operations. Invasive and in situ tumors were included. Postoperative complications within 30 days after surgery and the need for additional treatment were classified using the Clavien Dindo classification. Involved margin rates and subsequent re-excision were compared. RESULTS: We included 828 women with 842 breast cancers, who had a standard lumpectomy (62.7%) or oncoplastic resection (37.3%). OPS was performed more often for larger tumors (17.5 mm vs 13.6 mm, p = 0.002) and for tumors in the caudal half of the breast (33.1% vs 16.9%, p < 0.001). There was no significant difference in postoperative complications. Positive surgical margins were similar (OPS 22.6%, lumpectomy 18.2%, p = 0.119), as were re-excision rates (p = 0.337). CONCLUSION: Oncoplastic breast surgery can be safely applied in larger tumors, resulting in comparable postoperative complications, resection margins and re-excision rates compared to standard lumpectomy.