Vancomycin and Tobramycin Powder Use in Acute Open Fractures

• Status: Enrolling by invitation
• Trial end date: 2028-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The investigators overall aim of this study is to determine the difference in 6-month infection rates in patients treated with the combined vancomycin and tobramycin (VT) powder compared to the standard of care (SC).

In order to evaluate this objective, the investigators propose the following specific aims for the pilot study:

Specific Aim 1: Assess VT and SC patient enrollment, randomization and early clinical follow-up. Hypothesis: This study will successfully enroll and randomize 50 patients, 25 into each treatment group and will achieve 85% clinical follow-up at 6-months post-ED admission date.

Open fracture patients/families that meet study inclusion/exclusion criteria will be approached by a study team member for informed consent. After providing consent, patients will be appropriately randomized to either VT or SC treatment. Patients will be clinically followed at regular intervals up to 6 months post-surgery. Enrollment, appropriate randomization and surgical allocation, and clinical follow-up will be evaluated.

Specific Aim 2: Compare infection rates, cultures and patient characteristics between groups. Hypothesis: VT will have a lower infection rate than the SC group. Additionally, randomization will create an equal distribution of patient demographics as well as fracture severity and soft tissue damage, as classified by the Gustilo-Anderson Classification System (GA).

Specific Aim 3: Compare local wound healing and fracture healing between VT group and SC group. Hypothesis: VT will have less rates of wound healing complications due to decreased infections. No local wound irritation or wound closure issues will be seen between groups. There will be no difference in fracture healing between groups.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Utah
• Treatments: Anti-Bacterial Agents; Antibiotics, Antitubercular; Cefazolin; Ceftriaxone; Cephalosporins; Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Tobramycin; Vancomycin

Criteria

Inclusion Criteria:

• Open fracture GA class II or III, and one of the following fracture locations:

• Calcaneus fracture,

• Tibial plafond (pilon) fracture,

• Tibial plateau fracture,

• Tibial shaft fracture,

• Distal femur fracture,

• Femoral shaft fracture.

• Informed consent can be obtained from the patient.

• Consent will be obtained in the Emergency Department.

Exclusion Criteria:

• Known allergy to vancomycin or tobramycin.

• Known kidney disease prior to admission, chronic Kidney Disease stage 4 -5.

• Any patients, family members, or staff who refuse to participate.

• Pregnant women, as identified through pregnancy test which is taken in the emergency department as standard of care.