Acute Application of Antibiotic Powder in Open Fracture Wounds

Completed · Phase 4

Conditions studied: Fractures, Open, Wounds and Injuries--Infections, Anti-Bacterial Agents, Fractures, Bone, Extremity Fracture Lower, Extremity Fractures Upper

In brief

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 the way they were injured. Surgical site infection in the orthopedic surgery population is a big public health issue. Wound infections result in both longer length of hospital stay and total cost of care. This study will be using an antibiotic called Vancomycin or Tobramycin in a powder form.

Key facts

Study ID

NCT04872400

Run by

University of Colorado, Denver

People needed

20

Starts

2021-06-14

Expected to finish

2023-09-30

Last updated by the study team

2026-03-06

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• University of Colorado Anschutz — Aurora, Colorado, United States
• Denver Health and Hospital Authority — Denver, Colorado, United States

Full record on ClinicalTrials.gov

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