Antibiotic powder sprinkled in wounds may cut infection risk after severe leg fractures
NCT ID NCT02227446
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
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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
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18 to 80 years
- Sex
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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 Hide 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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Other studies related to the condition(s) this trial covers.
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