Comparing sutures and staples for closing wounds in orthopedic surgery
A Randomized Study of Suture Versus Staples for Wound Closure in Orthopaedic Trauma Surgery
This study is testing whether using sutures or staples to close wounds after surgery for lower leg fractures works better for adults aged 18 to 80.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University of Southern California Academic / other |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT06586814 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to evaluate the feasibility of comparing two methods of skin closure—sutures versus staples—following open reduction and internal fixation surgery for lower extremity fractures. The study will enroll adult patients aged 18 to 80 with specific types of closed fractures and will randomize them to receive either nylon sutures or metallic staples for wound closure. The primary objectives include assessing enrollment, randomization, and compliance, as well as refining data collection methods. Participants will be followed up with standard care and will complete PROMIS surveys to assess outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-80 with closed tibial plateau, tibial pilon, patella, or distal femur fractures.
Not a fit: Patients with open fractures, incarcerated individuals, pregnant women, or those with certain skin conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help determine the most effective wound closure method, potentially reducing the risk of surgical site infections.
How similar studies have performed: Previous studies comparing sutures and staples have shown varying results, making this approach both relevant and necessary for further investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Los Angeles, California
- University of Southern California — Los Angeles, California, United States (Recruiting)
Study contacts
- Study coordinator: Pui Yan, MS
- Email: puiyan@med.usc.edu
- Phone: 323-442-6984
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.