Implementation of Vancomycin Powder Application in the Emergency Department for Open Fractures

ConditionOpen Fracture

Trial statusNot yet recruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age18+

SponsorAtlantic Health System

About this trial

To evaluate the feasibility, safety, and potential efficacy of applying vancomycin powder locally to open fractures in the emergency department prior to definitive surgical intervention.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants aged 18 years or older presenting to the Emergency Department with Gustilo-Anderson Type I, II, or III open fractures.

Disqualifiers

Known allergy to vancomycin

Ballistic open fractures

Pregnancy

Currently breastfeeding

Trial design

Design model

Parallel

Treatments tested in this trial

Vancomycin (VAN) treatment
Drug
A single 1-gram dose of sterile vancomycin powder is applied directly to the open fracture wound in the Emergency Department after initial wound assessment and irrigation and prior to definitive operative debridement and fixation.
Standard Open Fracture Care
Other intervention
Standard management of open fractures according to institutional protocols, including intravenous antibiotics, wound care, irrigation, operative debridement, and fracture stabilization as indicated, without topical vancomycin powder application in the Emergency Department.

Treatment groups

100 Participants

are divided into 2 treatment groups

Group A: Emergency Department Vancomycin PowderExperimental treatment 1 intervention

Group B: Standard Open Fracture CareActive comparator 1 intervention

Trial outcomes

Primary outcomes

Deep Surgical Site Infection

Incidence of deep surgical site infection following open fracture treatment, defined according to Centers for Disease Control and Prevention (CDC)/National Healthcare Safety Network (NHSN) criteria and/or requiring operative irrigation and debridement or deep culture-directed antibiotic treatment.

Time frame

Defined as the proportion of participants who develop a deep surgical site infection involving the open fracture site within 90 days of injury or index operative treatment.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Atlantic Health System

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: