Medical Devices: Evidence and Research (Feb 2021)
Real-World Outcomes of Patients Undergoing Open Colorectal Surgery with Wound Closure Incorporating Triclosan-Coated Barbed Sutures: A Multi-Institution, Retrospective Database Study
Abstract
Barbara H Johnson,1 Pragya Rai,1 Se Ryeong Jang,2 Stephen S Johnston,1 Brian Po-Han Chen3 1Real World Data Analytics and Research, Epidemiology, Medical Devices, Johnson & Johnson, New Brunswick, NJ, USA; 2College of Population Health, Thomas Jefferson University, Philadelphia, PA, USA; 3Health Economics and Market Access, Ethicon Inc., Somerville, NJ, USACorrespondence: Stephen S JohnstonMedical Device Epidemiology and Real-World Data Analytics and Research, Johnson & Johnson, New Brunswick, NJ, 08901, USAEmail [email protected]: Open colorectal surgery is associated with a high rate of postoperative wound complications. This is a single-arm study of real-world outcomes of triclosan-coated barbed suture (Ethicon’s STRATAFIXTM Symmetric PDSTM Plus Knotless Tissue Control Device [SSPP]) used in open colorectal surgery.Methods: Retrospective cohort study using the Premier Healthcare Database. The study included patients who underwent an inpatient open colorectal surgery with wound closure using SSPP (size 0 or 1 to increase the likelihood the suture was used in fascia) between October 2015–September 2019 (N=593). Wound complications, hospital length of stay, total hospital costs (2019 US$), and all-cause readmissions post-discharge were measured. Post-hoc multivariable analyses compared wound complications between non-elective admissions and elective.Results: The overall incidence of wound complications within 30-days post-procedure was 7.1%, with the majority of those being surgical site infections (SSI) (6.0%). Mean operation time was 190 (standard deviation [SD]=64.4) mins, postoperative length of stay was 8.1 (SD=11.9) days, 30-day readmission rate was 11.8%, and total hospital costs were $31,693 (SD=$40,076). As compared with published literature on the rate of SSI in colorectal surgery, the 30-day rate of SSI in the present study (6.0%) fell within the range of 5.4% to 18.2% for open colorectal surgery and from 4.3% to 21.5% for combined open and minimally invasive procedures. Multivariable-adjusted incidence proportions of wound complications were slightly lower for non-elective admissions and did not differ significantly from those of elective admissions.Conclusion: The rate of wound complications observed in the present study falls within the range of rates previously reported in the literature, suggesting a safe and effective role for SSPP in open colorectal surgery. In post hoc analyses, the adjusted rate of wound complications was similar between non-elective and elective admissions. Head-to-head studies are required to determine comparative advantages or disadvantages for SSPP versus other sutures.Keywords: open colorectal surgery, barbed sutures, sigmoidectomy, surgical site infections, wound dehiscence
