Suture Versus Staples for Wound Closure in Orthopaedic Trauma Surgery

NCT06586814 | Active Not Recruiting

• 1 other identifier: HS-24-00012
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Lower Extremity Fracture

Outcome Measures

Primary Outcomes (3)

• Feasibility of participant enrollment

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

  12 Months

• Feasibility of randomization to each of the treatments

  \- Rate of consent

  6 Months

• Assess Protocol Compliance

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

  6 Months

Study Arms (2)

Suture

OTHER

Wound Closure

Other: Suture

Staple

OTHER

Wound Closure

Other: Staple

Interventions

Suture OTHER

Wound Closure

Suture

Staple OTHER

Wound Closure

Staple

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (1)

University of Southern California

Los Angeles, California, 90033, United States

Location

MeSH Terms

Interventions

Sutures

Intervention Hierarchy (Ancestors)

Surgical Fixation Devices; Surgical Equipment; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 19, 2024
• First Posted: September 19, 2024
• Study Start: August 1, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)