Antibiotic Powder for Open Fractures

Palo Alto (17 mi)

Overseen byJustin Haller, M.D.

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Waitlist Available

Sponsor: University of Utah

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for patients with open fractures of specific bones (like the heel, shinbone, or thigh bone) and a moderate to severe injury grade. They must be able to give consent in the emergency department. It's not for those allergic to vancomycin or tobramycin, have advanced kidney disease, are pregnant, or refuse participation.

Treatment Details

The study aims to compare infection rates between two groups: one receiving standard care antibiotics and another getting a combination of vancomycin and tobramycin powder. Each group will have 25 patients randomly assigned and followed up for six months post-surgery.

2Treatment groups

Experimental Treatment

Active Control

Group I: Vancomycin and TobramycinExperimental Treatment1 Intervention

One-time dosage of topical vancomycin (1 gram) and tobramycin (1.2 grams) powder.

Group II: Standard of care prophylactic antibioticsActive Control1 Intervention

Standard irrigation and IV, cephalosporin, 2-grams, intravenous (IV), * or standard irrigation and IV, clindamycin (900mg) / vancomycin (20mg/kg), intravenous (IV) for patients with cephalosporin allergies.