NCT06586814

Suture Versus Staples for Wound Closure in Orthopaedic Trauma Surgery

A Randomized Study of Suture Versus Staples for Wound Closure in Orthopaedic Trauma Surgery

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: University of Southern California · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Lower Extremity Fracture

Interventions

Type	Name	Description
OTHER	Suture	Wound Closure
OTHER	Staple	Wound Closure

Timeline

• Start date: 2024-08-01
• Primary completion: 2025-12-31
• Completion: 2026-12-31
• First posted: 2024-09-19
• Last updated: 2026-03-27

Locations

1 site across 1 country: United States