Real-World Outcomes of Patients Undergoing Open Colorectal Surgery with Wound Closure Incorporating Triclosan-Coated Barbed Sutures: A Multi-Institution, Retrospective Database Study

Barbara H Johnson; Pragya Rai; Se Ryeong Jang; Stephen S Johnston; Brian Po-Han Chen

doi:10.2147/MDER.S297671

Real-World Outcomes of Patients Undergoing Open Colorectal Surgery with Wound Closure Incorporating Triclosan-Coated Barbed Sutures: A Multi-Institution, Retrospective Database Study

Med Devices (Auckl). 2021 Feb 24:14:65-75. doi: 10.2147/MDER.S297671. eCollection 2021.

Authors

Barbara H Johnson¹, Pragya Rai¹, Se Ryeong Jang², Stephen S Johnston¹, Brian Po-Han Chen³

Affiliations

¹ Real World Data Analytics and Research, Epidemiology, Medical Devices, Johnson & Johnson, New Brunswick, NJ, USA.
² College of Population Health, Thomas Jefferson University, Philadelphia, PA, USA.
³ Health Economics and Market Access, Ethicon Inc., Somerville, NJ, USA.

Abstract

Purpose: 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 STRATAFIX^TM Symmetric PDS^TM 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: barbed sutures; open colorectal surgery; sigmoidectomy; surgical site infections; wound dehiscence.

Grants and funding

Sponsorship for this study, the article processing charges, and Open Access fee was funded by Johnson & Johnson (Ethicon, Somerville, NJ).