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Stitches or staples? small study aims to settle the debate for leg fracture surgery

NCT ID NCT06586814

Knowledge-focused Sponsor: University of Southern California Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This pilot study tests whether stitches or staples are better for closing surgical wounds after fixing broken leg bones. About 50 adults with certain leg fractures will be randomly assigned to one closure method. The main goal is to see if such a study is practical, not to prove which method is best.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
sutures and staples
What this could lead to
If successful, this study could show which wound closure method leads to fewer infections after orthopedic trauma surgery.
What could go wrong
This is a small pilot study with only 50 participants, so results may not apply to everyone. It focuses on feasibility, not definitive outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2024

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

tibia fracture

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Lower extremity fracture

Contacts and locations

Locations

  • University of Southern California

    Los Angeles, California, 90033, United States

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