Can a low-cost wound vacuum prevent infections after severe leg fractures?
NCT ID NCT07790991
First seen Aug 27, 2026 · Last updated Aug 28, 2026 · Updated 1 time
Summary
This pilot trial tests whether a low-cost negative pressure wound therapy (NPWT) system is a practical alternative to standard dressings for severe open tibia fractures in a low-resource setting. Researchers will randomly assign 66 adults with Gustilo-Anderson type IIIb open tibia fractures to receive either the low-cost NPWT or standard wound dressings after surgical cleaning. The main goal is to see if a larger trial is feasible, looking at recruitment, adherence, and safety. Infection rates within three months will be measured as an exploratory outcome, but the study is not designed to prove which treatment works better.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Low-cost negative pressure wound therapy (NPWT) system
- What this could lead to
- If this pilot succeeds, it could pave the way for a larger trial that may prove a low-cost NPWT system helps prevent infections in severe open leg fractures, making advanced wound care affordable in low-resource hospitals.
- What could go wrong
- This is a small pilot study, not designed to prove effectiveness. The single-center design and lack of blinding may limit how well the results apply to other settings, and the low-cost system may not match the performance of commercial NPWT.
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
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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
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About 66 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2027
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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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 years and older
- Sex
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Anyone
- Healthy volunteers
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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 adult patients (age ≥18 years) * admitted at orthopedic and trauma departement * between 1 January 2027 and 31 December 2027, * within 72 hours of sustaining an open tibial fracture Gustilo IIIb * before and after debridement Exclusion Criteria: * diabetes mellitus, * peripheral vascular disease, * vascular injury requiring repair, * chronic steroid use, * coagulopathies, * cancer; * open fractures older than 3 days; * fractures previously operated on; * chronic osteomyelitis; * primary amputation, * immunosuppression, * multiple fractures, * polytrauma, * pregnancy; * preexisting dermatological conditions.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Université Catholique de Bukavu
Bukavu, South Kivu, B.P.285, Democratic Republic of the Congo
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Université Catholique de Bukavu
Bukavu, South Kivu, B.P.285, Democratic Republic of the Congo
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