RECRUITING

Suture Versus Staples for Wound Closure in Orthopaedic Trauma Surgery

Description

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 Overview

Study Details

Study 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.

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

Suture Versus Staples for Wound Closure in Orthopaedic Trauma Surgery

Condition
Lower Extremity Fracture
Intervention / Treatment

-

Contacts and Locations

Los Angeles

University of Southern California, Los Angeles, California, United States, 90033

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Southern California,

Study Record Dates

2026-12-31