Suture Versus Staples for Wound Closure in Orthopaedic Trauma Surgery (NCT06586814) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Suture Versus Staples for Wound Closure in Orthopaedic Trauma Surgery
United States50 participantsStarted 2024-08-01
Plain-language 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Feasibility of participant enrollment
Timeframe: 12 Months
2
Feasibility of randomization to each of the treatments