Status:
COMPLETED
Acute Application of Antibiotic Powder in Open Fracture Wounds
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
Denver Health and Hospital Authority
Conditions:
Fractures, Open
Wounds and Injuries--Infections
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to help determine the best treatment for severe injures like open fracture wounds. Some broken bone injuries can be more likely to get an infection. It is mostly due to t...
Detailed Description
The investigators aim to investigate the effectiveness of preoperative intrawound antibiotic powder in preventing infection and reducing bacterial burden after open fracture. The investigators hypoth...
Eligibility Criteria
Inclusion
- Subject or proxy willing and able to provide written informed consent.
- Age between 18 years and 80 years (inclusive), with an upper or lower extremity Gustilo Type II, IIIA, or IIIB open fractures requiring debridement and internal fixation.
- Open extremity fractures
- Time from injury to study intervention 24 hours or less
Exclusion
- Individuals under the age of 18 years or over 80 years
- Type I or IIIC open fractures
- Over 24 hours from time of injury
- Subjects who have received acute operative care of the open fracture at an outside facility prior to presenting at the Emergency Department.
- Open fractures distal to the wrist and midfoot
- History of chronic infection in the extremity involved.
- Subjects who are currently pregnant
- Subjects who are Prisoners
- Subjects with a known allergy to vancomycin or tobramycin
- Subjects with a condition or social circumstances that would reduce adherence and follow-up.
- Subjects Participating in other clinical research involving investigational antimicrobial products within 30 days of randomization.
Key Trial Info
Start Date :
June 14 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04872400
Start Date
June 14 2021
End Date
September 30 2023
Last Update
February 5 2024
Active Locations (2)
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1
University of Colorado Anschutz
Aurora, Colorado, United States, 80045
2
Denver Health and Hospital Authority
Denver, Colorado, United States, 80204