Suture Versus Staples for Wound Closure in Orthopaedic Trauma Surgery

N/AActive Not RecruitingNCT06586814

University of Southern California50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Lower Extremity Fracture

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

\- Hitting target enrollment in 12 months, enrolling 50% of eligible patients

Time frame: 12 Months

Feasibility of randomization to each of the treatments

\- Rate of consent

Time frame: 6 Months

Assess Protocol Compliance

* Percentage of survey completion * Percentage of follow-up * Percentage of completed planned outcomes measures