A Randomized Study of Suture Versus Staples for Wound Closure in Orthopaedic Trauma Surgery
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Lower Extremity Fracture
- Sponsor
- University of Southern California
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Feasibility of participant enrollment
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief 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.
Investigators
Joshua Gary
Associate Professor
University of Southern California
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Feasibility of participant enrollment
Time Frame: 12 Months
- Hitting target enrollment in 12 months, enrolling 50% of eligible patients
Feasibility of randomization to each of the treatments
Time Frame: 6 Months
- Rate of consent
Assess Protocol Compliance
Time Frame: 6 Months
* Percentage of survey completion * Percentage of follow-up * Percentage of completed planned outcomes measures