Clinical Outcomes Among Patients Undergoing Open Abdominal or Orthopedic Surgery with Wound Closure Incorporating Triclosan-Coated Barbed Sutures: A Multi-Institutional, Retrospective Database Study

Stephen P Fortin,1 Kerstin Spychaj,2 Jörg Tomaszewski,3 Holly Grebeck,3 Rithwik Yalla,4 Paul M Coplan,1,5 Shumin Zhang1 1MedTech Epidemiology and Real-World Data Science, Office of the Chief Medical Officer, Johnson & Johnson, New Brunswick, New Jersey, USA; 2Clinical Research, Johnson & Johnson MedTech, Raritan, New Jersey, USA; 3Medical Affairs, Johnson & Johnson MedTech, Raritan, New Jersey, USA; 4Mu Sigma, Bangalore, India; 5University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USACorrespondence: Stephen P Fortin, MedTech Epidemiology and Real-World Data Science, Office of the Chief Medical Officer, Johnson & Johnson, New Brunswick, NJ, USA, Tel +1 908 927 4844, Email [email protected]: Determining the best suture for wound closure in high-tension areas by anatomical site and procedure type remains a challenge. This study assessed the cumulative incidence of clinical outcomes among patients undergoing procedures incorporating the STRATAFIX Symmetric PDS™ Plus Knotless Tissue Control Device (STRATAFIX Symmetric) for closure of high-tension areas, such as the abdominal fascia and hip and knee joint capsule, in the course of routine clinical practice.Patients and Methods: Patients undergoing open abdominal or orthopedic surgery between October 1, 2016, and October 31, 2023, using size 0 or 1 STRATAFIX Symmetric were identified from the Premier Healthcare Database. The cumulative incidences of 30-day internal wound dehiscence and 30-day surgical site infection (SSI) were measured. To contextualize the results, a targeted literature search of articles published between October 2016 and April 2024 describing the use of STRATAFIX Symmetric for wound closure in the abdominal fascia or joint capsule was performed.Results: A total of 8156 patients undergoing open abdominal surgery and 25,807 patients undergoing open orthopedic surgery met the study criteria. In the abdominal surgery cohort, the cumulative incidences of 30-day internal wound dehiscence and SSI were 0.65% (95% CI: 0.49%, 0.85%) and 3.54% (95% CI: 3.15%, 3.97%), respectively. The overall cumulative incidences of 30-day internal wound dehiscence and SSI in the orthopedic surgery cohort were 0.07% (95% CI: 0.04%, 0.11%) and 0.58% (95% CI: 0.49%, 0.68%), respectively. These findings were within the range of clinical outcomes reported in 12 articles identified during the targeted literature search.Conclusion: The cumulative incidence of 30-day internal wound dehiscence and SSI among patients undergoing abdominal and orthopedic procedures incorporating STRATAFIX Symmetric for wound closure of high-tension areas was low and comparable to prior literature.Keywords: barbed suture, STRATAFIX Symmetric, fascia, joint capsule, abdominal surgery, orthopedic surgery