Acute Application of Antibiotic Powder in Open Fracture Wounds

Phase 4

Completed

• Conditions: Anti-Bacterial Agents; Extremity Fracture Lower; Extremity Fractures Upper; Fractures, Open; Wounds and Injuries--Infections; Fractures, Bone
• Interventions: Drug: Vancomycin; Drug: Tobramycin

• Registration Number: NCT04872400
• Lead Sponsor: University of Colorado, Denver

Brief Summary

The purpose of this study is to help determine the best treatment for severe injures like open fracture wounds.

Some broken bone injuries can be more likely to get an infection. It is mostly due to the way they were injured. Surgical site infection in the orthopedic surgery population is a big public health issue. Wound infections result in both longer length of hospital stay and total cost of care. This study will be using an antibiotic called Vancomycin or Tobramycin in a powder form.

Detailed Description

The investigators aim to investigate the effectiveness of preoperative intrawound antibiotic powder in preventing infection and reducing bacterial burden after open fracture.

The investigators hypothesize that the participants who receive preoperative intrawound antibiotic powder will have fewer superficial and deep surgical site infections compared to participants who do not receive the antibiotic powder. The investigators also anticipate that the application of the antibiotic powder to open fracture wounds preoperatively will decrease the bacterial burden.

Sample swabs will be analyzed using the 16S metagenomics sequencing on the Illumina platform. Both RNA and DNA extracts will be utilized to identify and quantify the bacterial load in the wound bed at the time immediately prior to surgical debridement.

Study Timeline

• Study First Submitted: 2021-04-29
• Study First Submitted QC: 2021-04-29
• Study First Posted: 2021-05-04
• Study Start: 2021-06-14
• Primary Completion: 2023-09-30
• Study Completion: 2023-09-30
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-02
• Last Update Posted: 2024-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Subject or proxy willing and able to provide written informed consent.
• Age between 18 years and 80 years (inclusive), with an upper or lower extremity Gustilo Type II, IIIA, or IIIB open fractures requiring debridement and internal fixation.
• Open extremity fractures
• Time from injury to study intervention 24 hours or less

Exclusion Criteria

• Individuals under the age of 18 years or over 80 years
• Type I or IIIC open fractures
• Over 24 hours from time of injury
• Subjects who have received acute operative care of the open fracture at an outside facility prior to presenting at the Emergency Department.
• Open fractures distal to the wrist and midfoot
• History of chronic infection in the extremity involved.
• Subjects who are currently pregnant
• Subjects who are Prisoners
• Subjects with a known allergy to vancomycin or tobramycin
• Subjects with a condition or social circumstances that would reduce adherence and follow-up.
• Subjects Participating in other clinical research involving investigational antimicrobial products within 30 days of randomization.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vancomycin	Vancomycin	Subjects randomized to the Intervention arm will receive standard of care plus 1 gram of vancomycin powder applied topically to the wound bed before the dressing is applied. Intervention will occur in the emergency room prior to surgical intervention.
Tobramycin	Tobramycin	Subjects randomized to the Intervention arm will receive standard of care plus 1.2 grams of tobramycin powder applied topically to the wound bed before the dressing is applied. Intervention will occur in the emergency room prior to surgical intervention.

Primary Outcome Measures

Name	Time	Method
Incidence of surgical site infection during the post-operative follow-up period	Within 6 months of injury date	The percentage of participants who develop an infection at the surgical site following debridement and fixation at the follow up period.

Secondary Outcome Measures

Name	Time	Method
Shannon's index measure of bacterial diversity based on wound cultures	Within 1 year of injury date	Characterize species and determine whether changes in biodiversity differ across study arms.
Simpson index measure of bacterial diversity based on the wound cultures	Within 1 year of injury date	Consider the number of bacterial species present, alongside the relative abundance of each specie across study arms.
Presence of bacterial species commonly attributed to surgical site infections based on would cultures including: Staph, enterococcus, acinetobacter, enterobacter, e. coli, klebsiella, and pseudomonas	Within 1 year of injury date	Understand the changes that occur in the presence of bacterial species associated with surgical site infection after antibiotic powder treatment .

Trial Locations

Locations (2)

University of Colorado Anschutz; 🇺🇸 Aurora, Colorado, United States

Denver Health and Hospital Authority; 🇺🇸 Denver, Colorado, United States