Clinical trial NCT04872400: Acute Application of Antibiotic Powder in Open Fracture Wounds
Official title: Acute Application Of Intrawound Antibiotic Powder In Open Extremity Fracture Wounds
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Fractures, Open
Wounds and Injuries--Infections
Anti-Bacterial Agents
Fractures, Bone
Extremity Fracture Lower
Extremity Fractures Upper
Keywords: Open fractures
Antibiotic powder
Vancomycin
Tobramycin
Infection
Gustilo
16S
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Denver Health and Hospital Authority
First posted: 2021-05-04
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The management of open fractures involves an expedited administration of systemic antibiotics and while effective in reducing the rate of infection, complications from infections are still common following open fractures. This trial aims to evaluate the incidence of surgical site infections using topical vancomycin antibiotic powder or topical tobramycin antibiotic powder in combination with standard of care treatment and to evaluate the effectiveness of both topical antibiotic powders in reducing surgical site infection.
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of surgical site infection during the post-operative follow-up period
timeFrame: Within 6 months of injury date
Secondary outcomes:
measure: Shannon's index measure of bacterial diversity based on wound cultures
timeFrame: Within 1 year of injury date
measure: Simpson index measure of bacterial diversity based on the wound cultures
timeFrame: Within 1 year of injury date
measure: Presence of bacterial species commonly attributed to surgical site infections based on would cultures including: Staph, enterococcus, acinetobacter, enterobacter, e. coli, klebsiella, and pseudomonas
timeFrame: Within 1 year of injury date
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Anschutz
state: Colorado
city: Denver
country: United States
facility: Denver Health and Hospital Authority
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Nicholas Alfonso, MD
role: PRINCIPAL_INVESTIGATOR
References: