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A Randomized Study of Suture Versus Staples for Wound Closure in Orthopaedic Trauma Surgery
This pilot study is designed to assess the feasibility of comparing skin closure methods - sutures versus staples - and subsequent rates of surgical site infection following open reduction and internal fixation surgery for orthopaedic trauma injuries. The primary objectives are to determine if enrollment, randomization, and compliance are feasible and to refine data collection methods. Patients =18 years of age with closed fractures of the tibial plateau, tibial pilon, patella, and distal femur presenting within 3 weeks of injury undergoing definitive treatment of their fracture will be approached for participation. If enrolled, they will be randomized to having their surgical wound closed with either nylon sutures or metallic staples. Patient follow up will be standard of care besides answering PROMIS surveys.
Age
18 - 80 years
Sex
ALL
Healthy Volunteers
No
University of Southern California
Los Angeles, California, United States
Start Date
August 1, 2024
Primary Completion Date
December 31, 2025
Completion Date
December 31, 2026
Last Updated
September 19, 2024
50
ESTIMATED participants
Suture
OTHER
Staple
OTHER
Lead Sponsor
University of Southern California
NCT05699174
NCT05381818
Data Source & Attribution
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