Vancomycin and Tobramycin Powder Use in Acute Open Fractures

NCT05849090 | Completed Early Phase 1 DMC FDA Drug

• 1 other identifier: 158712
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Infections

Keywords

Infections; Acute open fractures; Standard of care prophylactic antibiotics; Vancomycin and Tobramycin powder

Outcome Measures

Primary Outcomes (2)

• Percent (%) positive deep tissue infections.

  Percent (%) of positive deep tissue infections (number of infections/total participants X 100).

  6-months post-operative

• Percent (%) negative deep tissue infections.

  Percent (%) of negative deep tissue infections (number of infections/total participants X 100).

  6-months post-operative

Study Arms (2)

Standard of care prophylactic antibiotics

ACTIVE COMPARATOR

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.

Drug: Cephalosporin or clindamycin/vancomycin antibiotics..

Vancomycin and Tobramycin

EXPERIMENTAL

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

Drug: Vancomycin and Tobramycin antibiotics.

Interventions

Cephalosporin or clindamycin/vancomycin antibiotics.. DRUG

Antibiotics: Cephalosporin, 2-grams, intravenous (IV), or clindamycin (900mg) / vancomycin (20mg/kg), intravenous (IV).

Also known as: Cephalosporin - Cefazolin, (Ancef, Kefzol, Cefacidil), Cephalosporin- Ceftriaxone, (Ceftrisol Plus, Rocephin), Clindamycin, (Cleocin, Clindesse), Vancomycin, (Vancocin)

Standard of care prophylactic antibiotics

Vancomycin and Tobramycin antibiotics. DRUG

Vancomycin (1 gram) and tobramycin (1.2 grams).

Also known as: Vancomycin, (Vancocin), Tobramycin, (Tobi, Tobrex, Nebcin)

Vancomycin and Tobramycin

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah Orthopaedic Center

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Infections

Interventions

Cephalosporins; Clindamycin; Cefazolin; Ceftriaxone; clindamycin phosphate; Vancomycin; Tobramycin

Intervention Hierarchy (Ancestors)

beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lincomycin; Lincosamides; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Glycosides; Carbohydrates; Cefotaxime; Cephacetrile; Glycopeptides; Glycoconjugates; Peptides; Amino Acids, Peptides, and Proteins; Nebramycin; Kanamycin; Aminoglycosides

Study Officials

• Justin Haller, M.D.

  University of Utah Orthopaedics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: April 11, 2023
• First Posted: May 8, 2023
• Study Start: March 27, 2023
• Primary Completion: December 12, 2024
• Study Completion: December 12, 2024
• Last Updated: December 20, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)