RECRUITING

Suture Versus Staples for Wound Closure in Orthopaedic Trauma Surgery

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-08-01
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06586814

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.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adult Patients 18-80 years old
  2. * Tibial Pilon, Tibial Plateau Fractures, Patella Fractures, and Distal Femur Fractures
  3. * Incisions must be able to be approximated with subdermal sutures intraoperatively
  4. * English and Spanish speaking patients only
  1. * Open fractures
  2. * Incarcerated patients
  3. * Pregnant patients
  4. * Patients who do not speak English or Spanish
  5. * History of infection at surgical incision site at the time of definitive fixation
  6. * Pre-existing skin condition associated with risk of infection (psoriasis, eczema)
  7. * 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.
  8. * The absence of a subcutaneous closure during the index procedure

Contacts and Locations

Study Contact

Pui Yan, MS
CONTACT
323-442-6984
puiyan@med.usc.edu

Study Locations (Sites)

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

Collaborators and Investigators

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 Registration Dates

Study Start Date2024-08-01
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2024-08-01
Study Completion Date2026-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Lower Extremity Fracture