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New treatment option for Fracture Open Tibia
Official title Gentamicin Open Tibia Study
ClinicalTrials.gov ID: NCT05157126
What this study is testing
What is Gentamicin?
Gentamicin is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for fracture open tibia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Local application of antibiotics directly to the traumatic wound is a promising treatment for the prevention of infection after open tibia fractures, which are a significant source of disease burden globally, particularly in low-income countries. This study aims to measure the effect of locally applied gentamicin on risk of infection for open tibial fractures in Tanzania.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age\>18 years old
- Open tibial shaft fracture meeting the following criteria:
- Orthopaed Trauma Association (OTA) Type 42
- Primarily closable wound
- Gustilo-Anderson (GA) Type I, II, or IIIA
You likely can't join if
- Time from injury to presentation \> 48 hours
- Time from injury to surgery \> 7 days
- Aminoglycoside allergy
- GA IIIB or IIIC open fractures
- Bilateral open tibial fractures
- Severe brain (GCS\<12) or spinal cord injury
See the full eligibility criteria
- Age\>18 years old
- Open tibial shaft fracture meeting the following criteria:
- Orthopaed Trauma Association (OTA) Type 42
- Primarily closable wound
- Gustilo-Anderson (GA) Type I, II, or IIIA
- Time from injury to presentation \> 48 hours
- Time from injury to surgery \> 7 days
- Aminoglycoside allergy
- GA IIIB or IIIC open fractures
- Bilateral open tibial fractures
- Severe brain (GCS\<12) or spinal cord injury
- Severe vascular injury
- Severe burns (\>10% Total Body Surface Area (TBSA) or \>5% TBSA with full thickness or circumferential injury)
- Pathologic fracture
- History of active limb infection, ipsilaterally
- Unlikely to complete follow-up
The study team makes the final eligibility decision.
Where it's taking place
- Dar es Salaam, Tanzania
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dar es Salaam, Tanzania. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.