Pilot RCT Local Gentamicin for Open Tibial Fractures in Tanzania

NACompletedINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

November 19, 2019

Primary Completion Date

September 15, 2021

Study Completion Date

September 15, 2021

Conditions
Open Tibia Fracture
Interventions
DRUG

local gentamicin injection

Treatment includes debridement and administration of the local antibiotic which will consist of 80mg of liquid gentamicin diluted in 40mL normal saline injected after inserting a 22 gauge needle down to bone after wound closure. The injection will continue until either all 40cc are injected or there is fluid extravasation from the wound.

DRUG

placebo saline injection

Treatment includes debridement and administration of the local antibiotic which will consist of 40mL normal saline injected after inserting a 22 gauge needle down to bone after wound closure. The injection will continue until either all 40cc are injected or there is fluid extravasation from the wound.

Trial Locations (1)

Unknown

Muhimbili Orthopaedic Institute, Dar es Salaam

All Listed Sponsors
collaborator

Muhimbili Orthopaedic Institute

OTHER

collaborator

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NIH

lead

University of California, San Francisco

OTHER

NCT03559400 - Pilot RCT Local Gentamicin for Open Tibial Fractures in Tanzania | Biotech Hunter | Biotech Hunter