Acute Application of Antibiotic Powder in Open Fracture Wounds

• Status: Recruiting
• Trial end date: 2023-06-30
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Colorado, Denver
• Collaborator: Denver Health and Hospital Authority
• Treatments: Tobramycin; Vancomycin

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.