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Sutures vs Staples for Lower Extremity Fractures (SvS Trial)

N/A
Recruiting
Research Sponsored by University of Southern California
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with Tibial Pilon, Tibial Plateau Fractures, Patella Fractures, and Distal Femur Fractures
Adult Patients 18-80 years old
Must not have
Patients who do not speak English or Spanish
History of infection at surgical incision site at the time of definitive fixation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group

Summary

"This trial aims to investigate whether using sutures or staples to close surgical wounds after orthopedic trauma surgery affects the rate of surgical site infections. The study will enroll patients over 18 with certain types

Who is the study for?
This trial is for adults over 18 with closed fractures in specific lower leg bones (tibial plateau, tibial pilon, patella, distal femur) who are within three weeks of injury and undergoing surgery. Participants will be chosen randomly to have their surgical wounds closed either with sutures or staples.
What is being tested?
The study aims to compare the effectiveness of sutures versus staples in preventing infections after orthopaedic trauma surgeries. It's a pilot study focusing on feasibility: can they enroll enough people, assign them randomly to treatments, and get reliable data from follow-ups?
What are the potential side effects?
Potential side effects may include differences in wound healing times, risk of infection at the surgical site, pain levels at the closure site, scarring differences between sutures and staples, and possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a fracture in my lower leg, knee cap, or near my knee.
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I am between 18 and 80 years old.
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My surgical cuts can be closed with stitches under the skin.
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I speak English or Spanish.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not speak English or Spanish.
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I had an infection at the surgery site when my surgery was finalized.
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My initial surgery did not involve stitching under the skin.
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I have a broken bone that is exposed through my skin.
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I have a skin condition like psoriasis or eczema.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Assess Protocol Compliance
Feasibility of participant enrollment
Feasibility of randomization to each of the treatments

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: SutureExperimental Treatment1 Intervention
Wound Closure
Group II: StapleExperimental Treatment1 Intervention
Wound Closure

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Who is running the clinical trial?

University of Southern CaliforniaLead Sponsor
946 Previous Clinical Trials
1,604,569 Total Patients Enrolled
~33 spots leftby Dec 2025
Unbiased ResultsWe believe in providing patients with all the options.
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