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OpenTrials
Completed

NCT Number: NCT04872400

Acute Application of Antibiotic Powder in Open Fracture Wounds

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Colorado Anschutz, Aurora, Colorado, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vancomycin

Drug

1 vial of Vancomycin 1g powder applied topically to the open fracture wound injury.

Tobramycin

Drug

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

Primary outcomes

  1. Incidence of Surgical Site Infection During the Post-operative Follow-up Period

    Time frame: Within 6 months of injury date

    The percentage of participants who develop an infection at the surgical site following debridement and fixation at the follow up period.

Secondary outcomes

  1. Presence of Fracture Nonunion

    Time frame: Within 1 year of injury date

    Understand the changes that occur in nonunion after antibiotic powder treatment .

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • Denver Health and Hospital Authority

Registry information

Official study title

Acute Application Of Intrawound Antibiotic Powder In Open Extremity Fracture Wounds

Acronym: APOW

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
May 4, 2021
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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