Antibiotic powder sprinkled in wounds may cut infection risk after severe leg fractures

NCT ID NCT02227446

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Not yet recruiting
Registered, but not yet taking participants.
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The trial has finished. Results may not be published yet.
Stopped early
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Cancelled before anyone took part.

Expanded access (not trials)

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Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
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Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
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First seen Jul 06, 2026 · Last updated Jul 07, 2026 · Updated 1 time

Summary

This trial investigates whether placing vancomycin antibiotic powder directly into the wound during surgery can reduce deep surgical site infections in people with severe tibial plateau fractures. Participants are adults with high-energy fractures requiring plate and screw fixation. Half receive standard care plus vancomycin powder, and half receive standard care alone. The study tracks infections within six months after surgery.

What this could mean

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

Active substance
vancomycin antibiotic powder
What this could lead to
If it works, this could provide a simple, low-cost way to prevent serious infections after high-risk fracture surgery, reducing the need for additional operations and antibiotics.
What could go wrong
This is a single trial, and results may not apply to all fracture types or patients. Vancomycin powder could cause allergic reactions or contribute to antibiotic resistance, and it may not reduce infection rates as hoped.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

1,036 people

The number who actually took part.

Start date

Oct 2014

Finished

Nov 2019

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: * All "high energy" tibial plateau fractures treated operatively with plate and screw fixation. * We define "high energy" tibial plateau fractures as patients who are either: * Initially treated with an external fixation (with or without limited internal fixation) and treated definitively more than 3 days later after swelling has resolved. * Any open type I, II, or IIIA fracture, regardless of timing of definitive treatment. * Any tibial plateau fracture associated with ipsilateral leg compartment syndrome fasciotomy wounds. * All "high energy" pilon (distal tibial plafond) fractures treated operatively with plate and screw fixation. We define "high energy" pilon fractures as patients who are either: * Initially treated with an external fixation (with or without fibula fixation or limited internal fixation) and treated definitively more than 3 days later after swelling has resolved. * Any open type I, II, or IIIA fracture, regardless of timing of definitive treatment. * Any tibial pilon fracture associated with ipsilateral leg compartment syndrome fasciotomy wounds. * Ages 18 to 80 years * Patients may have co-existing non-tibial infection, with or without antibiotic treatment. * Patients may have risk factors for infection including diabetes, immunosuppression from steroids or other medications, HIV, or other infections. * Patients may have a head injury * Patients may have a portion of the fixation (e.g. fibula fixation in pilon or percutaneous screws across a tibial plateau fracture) prior to definitive plate fixation, at the initial surgery before randomization. * Patients may have other orthopedic and non-orthopaedic injuries. * Patients may have pre-existing musculoskeletal injuries, be non ambulators, or have spinal cord injuries. * Women and minorities are included Exclusion Criteria: * The study injury: tibial plateau, pilon, is already infected at time of study enrollment. * Patient speaks neither English nor Spanish. * Patients who have already had definitive fixation prior to enrollment in the study. * Severe problems with maintaining follow-up (e.g. patients who are homeless at the time of injury or those how are intellectually challenged without adequate family support). * Patients with allergies, drug administration reactions, or other sensitivities to Vancomycin (such as a history of Redman's Syndrome). * Pregnancy. * The study injury is a type IIIB or IIIC open fracture.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • University of Maryland R Adams Cowley Shock Trauma Center

    Baltimore, Maryland, 21201, United States

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