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NCT Number: NCT06586814

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Lower Extremity Fracture

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Southern California

Los Angeles, California, 90033, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Suture

Other

Wound Closure

Staple

Other

Wound Closure

Primary outcomes

  1. Feasibility of participant enrollment

    Time frame: 12 Months

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

  2. Feasibility of randomization to each of the treatments

    Time frame: 6 Months

    • Rate of consent

  3. Assess Protocol Compliance

    Time frame: 6 Months

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

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Registry information

Official study title

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

Acronym: SvS

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Sep 19, 2024
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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