Acute Application of Antibiotic Powder in Open Fracture Wounds

  • STATUS
    Recruiting
  • End date
    Jun 30, 2023
  • participants needed
    120
  • sponsor
    University of Colorado, Denver
Updated on 25 August 2021
injuries
internal fixation
open fracture

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.

Details
Condition Fractures of the Upper Limb, Bone Fractures, Fracture, antibacterial agents, Lower Extremity Fracture, antibacterial, antibacterials, antibacterial drugs, Open Fracture, fractures of the lower limb, antibacterial agent, Antibiotic, Wounds and Injuries--Infections
Treatment Vancomycin, Tobramycin
Clinical Study IdentifierNCT04872400
SponsorUniversity of Colorado, Denver
Last Modified on25 August 2021

Eligibility

Yes No Not Sure

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
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