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

University of Colorado Denver (CU Denver)

Status and phase: Completed; Phase 4

Conditions: Fractures, Open; Anti-Bacterial Agents; Extremity Fracture Lower; Extremity Fractures Upper; Wounds and Injuries--Infections; Fractures, Bone

Treatments: Drug: Tobramycin; Drug: Vancomycin

Study type: Interventional

Funder types: Other

Identifiers

NCT04872400

20-2957

5672 (Other Grant/Funding Number)

Details and patient eligibility

About

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 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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 3 patient groups

Control

No Intervention group

Description:

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

Vancomycin

Experimental group

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.

Treatment:

Drug: Vancomycin

Tobramycin

Experimental group

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.

Treatment:

Drug: Tobramycin