search
Back to results

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

Primary Purpose

Fractures, Open, Wounds and Injuries--Infections, Anti-Bacterial Agents

Status
Active
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Vancomycin
Tobramycin
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Fractures, Open focused on measuring Open fractures, Antibiotic powder, Vancomycin, Tobramycin, Infection, Gustilo, 16S

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Colorado Anschutz
  • Denver Health and Hospital Authority

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Control

Vancomycin

Tobramycin

Arm Description

Subjects randomized to the Control Arm will receive standard of care open fracture wound care (no powder) by the clinical team.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Shannon's index measure of bacterial diversity based on wound cultures
Characterize species and determine whether changes in biodiversity differ across study arms.
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.
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 .

Full Information

First Posted
April 29, 2021
Last Updated
January 23, 2023
Sponsor
University of Colorado, Denver
Collaborators
Denver Health and Hospital Authority
search

1. Study Identification

Unique Protocol Identification Number
NCT04872400
Brief Title
Acute Application of Antibiotic Powder in Open Fracture Wounds
Acronym
APOW
Official Title
Acute Application Of Intrawound Antibiotic Powder In Open Extremity Fracture Wounds
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 14, 2021 (Actual)
Primary Completion Date
July 31, 2023 (Anticipated)
Study Completion Date
August 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
Denver Health and Hospital Authority

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fractures, Open, Wounds and Injuries--Infections, Anti-Bacterial Agents, Fractures, Bone, Extremity Fracture Lower, Extremity Fractures Upper
Keywords
Open fractures, Antibiotic powder, Vancomycin, Tobramycin, Infection, Gustilo, 16S

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
The management of open fractures involves an expedited administration of systemic antibiotics and while effective in reducing the rate of infection, complications from infections are still common following open fractures. This trial aims to evaluate the incidence of surgical site infections using topical vancomycin antibiotic powder or topical tobramycin antibiotic powder in combination with standard of care treatment and to evaluate the effectiveness of both topical antibiotic powders in reducing surgical site infection.
Masking
Participant
Masking Description
This will be a single-blind study as only the participants will be blinded to the treatment.
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Subjects randomized to the Control Arm will receive standard of care open fracture wound care (no powder) by the clinical team.
Arm Title
Vancomycin
Arm Type
Experimental
Arm Description
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.
Arm Title
Tobramycin
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Vancomycin
Intervention Description
1 vial of Vancomycin 1g powder applied topically to the open fracture wound injury.
Intervention Type
Drug
Intervention Name(s)
Tobramycin
Intervention Description
1 vial of Tobramycin 1.2g powder applied topically to the open fracture wound injury.
Primary Outcome Measure Information:
Title
Incidence of surgical site infection during the post-operative follow-up period
Description
The percentage of participants who develop an infection at the surgical site following debridement and fixation at the follow up period.
Time Frame
Within 6 months of injury date
Secondary Outcome Measure Information:
Title
Shannon's index measure of bacterial diversity based on wound cultures
Description
Characterize species and determine whether changes in biodiversity differ across study arms.
Time Frame
Within 1 year of injury date
Title
Simpson index measure of bacterial diversity based on the wound cultures
Description
Consider the number of bacterial species present, alongside the relative abundance of each specie across study arms.
Time Frame
Within 1 year of injury date
Title
Presence of bacterial species commonly attributed to surgical site infections based on would cultures including: Staph, enterococcus, acinetobacter, enterobacter, e. coli, klebsiella, and pseudomonas
Description
Understand the changes that occur in the presence of bacterial species associated with surgical site infection after antibiotic powder treatment .
Time Frame
Within 1 year of injury date

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicholas Alfonso, MD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Anschutz
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Denver Health and Hospital Authority
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Acute Application of Antibiotic Powder in Open Fracture Wounds

We'll reach out to this number within 24 hrs