Acute Application of Antibiotic Powder in Open Fracture Wounds

Fractures, Bone Clinical Trial

— APOW  

Official title:

Acute Application Of Intrawound Antibiotic Powder In Open Extremity Fracture Wounds

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04872400
• Other study ID #: 20-2957
• Secondary ID: 5672
• Status: Completed
• Phase: Phase 4
• Start date: June 14, 2021
• Est. completion date: September 30, 2023

Study information

• Verified date: February 2024
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anti-Bacterial Agents
• Extremity Fracture Lower
• Fractures, Bone
• Fractures, Open
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
United States	University of Colorado Anschutz	Aurora	Colorado
United States	Denver Health and Hospital Authority	Denver	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	Denver Health and Hospital Authority

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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