Acute Application of Antibiotic Powder in Open Fracture Wounds (APOW)

Acute Application Of Intrawound Antibiotic Powder In Open Extremity Fracture Wounds

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.

Study Overview

• Status: Completed
• Conditions: Fractures, Bone; Fractures, Open; Anti-Bacterial Agents; Wounds and Injuries--Infections; Extremity Fracture Lower; Extremity Fractures Upper
• Intervention / Treatment: Drug: Vancomycin; Drug: Tobramycin

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Anschutz
    • Denver, Colorado, United States, 80204
      • Denver Health and Hospital Authority

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Subjects randomized to the Control Arm will receive standard of care open fracture wound care (no powder) by the clinical team.
Experimental: 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.	Drug: Vancomycin; 1 vial of Vancomycin 1g powder applied topically to the open fracture wound injury.
Experimental: 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.	Drug: Tobramycin; 1 vial of Tobramycin 1.2g powder applied topically to the open fracture wound injury.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: Denver Health and Hospital Authority
• Investigators: Principal Investigator: Nicholas Alfonso, MD, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2021
• Primary Completion (Actual): September 30, 2023
• Study Completion (Actual): September 30, 2023

Study Registration Dates

• First Submitted: April 29, 2021
• First Submitted That Met QC Criteria: April 29, 2021
• First Posted (Actual): May 4, 2021

Study Record Updates

• Last Update Posted (Estimated): February 5, 2024
• Last Update Submitted That Met QC Criteria: February 2, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Infection; Vancomycin; Tobramycin; 16S; Open fractures; Antibiotic powder; Gustilo
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone; Fractures, Open; Anti-Infective Agents; Anti-Bacterial Agents; Vancomycin; Tobramycin
• Other Study ID Numbers: 20-2957; 5672 (Other Grant/Funding Number: Orthopaedic Trauma Association)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No