Lower Extremity Fracture
Conditions
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.
Interventions
OTHERSuture
Wound Closure
OTHERStaple
Wound Closure
Sponsors
University of Southern California
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of participant enrollment | 12 Months | \- Hitting target enrollment in 12 months, enrolling 50% of eligible patients |
| Feasibility of randomization to each of the treatments | 6 Months | \- Rate of consent |
| Assess Protocol Compliance | 6 Months | * Percentage of survey completion * Percentage of follow-up * Percentage of completed planned outcomes measures |
Countries
United States
Outcome results
None listed