Suture Versus Staples for Wound Closure in Orthopaedic Trauma Surgery

Not Applicable

Recruiting

• Conditions: Lower Extremity Fracture
• Interventions: Other: Suture; Other: Staple

• Registration Number: NCT06586814
• Lead Sponsor: University of Southern California

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-07-19
• Study Start: 2024-08-01
• Status Verified: 2024-09
• Study First Submitted QC: 2024-09-04
• Last Update Submitted: 2024-09-04
• Study First Posted: 2024-09-06
• Last Update Posted: 2024-09-06
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Suture	Suture	Wound Closure
Staple	Staple	Wound Closure

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Southern California; 🇺🇸 Los Angeles, California, United States