Suture Versus Staples for Wound Closure in Orthopaedic Trauma Surgery
Running, not enrolling · Not applicable
Conditions studied: Lower Extremity Fracture
In brief
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.
Key facts
- Study ID
- NCT06586814
- Run by
- University of Southern California
- People needed
- 50
- Starts
- 2024-08-01
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2026-03-27
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Adult Patients 18-80 years old
- Tibial Pilon, Tibial Plateau Fractures, Patella Fractures, and Distal Femur Fractures
- Incisions must be able to be approximated with subdermal sutures intraoperatively
- English and Spanish speaking patients only
You may not qualify if…
- Open fractures
- Incarcerated patients
- Pregnant patients
- Patients who do not speak English or Spanish
- History of infection at surgical incision site at the time of definitive fixation
- Pre-existing skin condition associated with risk of infection (psoriasis, eczema)
- Unable to obtain consent from patient prior to surgery or from legally authorized representative (LAR) prior to skin closure if the patient is unable to consent dur to their medical condition.
- The absence of a subcutaneous closure during the index procedure
Where it is running
- University of Southern California — Los Angeles, California, United States
Full record on ClinicalTrials.gov
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