Vancomycin and Tobramycin Powder Use in Acute Open Fractures
Status:
Enrolling by invitation
Trial end date:
2028-03-01
Target enrollment:
Participant gender:
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.