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

IF 1.3 Q4 ENGINEERING, BIOMEDICAL Medical Devices-Evidence and Research Pub Date : 2025-03-06 eCollection Date: 2025-01-01 DOI:10.2147/MDER.S508169

Stephen P Fortin, Kerstin Spychaj, Jörg Tomaszewski, Holly Grebeck, Rithwik Yalla, Paul M Coplan, Shumin Zhang

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Abstract

Purpose: 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.

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