Vancomycin
Drug1 vial of Vancomycin 1g powder applied topically to the open fracture wound injury.
NCT Number: NCT04872400
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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Notify Me18 year–80 year
All sexes
Interventional
Phase 4
University of Colorado Anschutz, Aurora, Colorado, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
1 vial of Vancomycin 1g powder applied topically to the open fracture wound injury.
1 vial of Tobramycin 1.2g powder applied topically to the open fracture wound injury.
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.
Time frame: Within 1 year of injury date
Understand the changes that occur in nonunion after antibiotic powder treatment .
University of Colorado, Denver
Other
Acute Application Of Intrawound Antibiotic Powder In Open Extremity Fracture Wounds
Acronym: APOW
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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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