NCT04872400

Acute Application of Antibiotic Powder in Open Fracture Wounds

Acute Application Of Intrawound Antibiotic Powder In Open Extremity Fracture Wounds

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-06-14
• Primary completion: 2023-09-30
• Completion: 2023-09-30
• First posted: 2021-05-04
• Last updated: 2026-03-06
• Results posted: 2026-03-06

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study