Suture Versus Staples for Wound Closure in Orthopaedic Trauma Surgery (SvS)

March 26, 2026 updated by: Joshua Gary, University of Southern California

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

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

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Suture
Wound Closure
Other: Suture
Wound Closure
Other: Staple
Wound Closure
Other: Staple
Wound Closure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of participant enrollment
Time Frame: 12 Months
- Hitting target enrollment in 12 months, enrolling 50% of eligible patients
12 Months
Feasibility of randomization to each of the treatments
Time Frame: 6 Months
- Rate of consent
6 Months
Assess Protocol Compliance
Time Frame: 6 Months
  • Percentage of survey completion
  • Percentage of follow-up
  • Percentage of completed planned outcomes measures
6 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern California

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2024

Primary Completion (Actual)

December 31, 2025

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

July 19, 2024

First Submitted That Met QC Criteria

September 4, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 26, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HS-24-00012

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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