Acute Application of Antibiotic Powder in Open Fracture Wounds

Overview

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.

Full Title of Study: “Acute Application Of Intrawound Antibiotic Powder In Open Extremity Fracture Wounds”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Single (Participant)
  • Study Primary Completion Date: December 31, 2022

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.

Interventions

  • Drug: Vancomycin
    • 1 vial of Vancomycin 1g powder applied topically to the open fracture wound injury.
  • Drug: Tobramycin
    • 1 vial of Tobramycin 1.2g powder applied topically to the open fracture wound injury.

Arms, Groups and Cohorts

  • No Intervention: Arm 1
    • Subjects randomized to the Control Arm will receive standard of care open fracture wound care (no powder) by the clinical team.
  • Experimental: Arm 2
    • 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.
  • Experimental: Arm 3
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Incidence of surgical site infection during the post-operative follow-up period
    • Time Frame: 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 Measures

  • Shannon’s index measure of bacterial diversity based on wound cultures
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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 .

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Colorado, Denver
  • Collaborator
    • Denver Health and Hospital Authority
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Nicholas Alfonso, MD, Principal Investigator, University of Colorado, Denver
  • Overall Contact(s)
    • Nicholas Alfonso, MD, 303-724-5860, nicholas.alfonso@cuanschutz.edu

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