Acute Application of Antibiotic Powder in Open Fracture Wounds

University of Colorado, Denver20 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Fractures, Open

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Incidence of surgical site infection during the post-operative follow-up period

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

Time frame: Within 6 months of injury date

Secondary Outcomes

Shannon's index measure of bacterial diversity based on wound cultures

Characterize species and determine whether changes in biodiversity differ across study arms.

Time frame: Within 1 year of injury date

Simpson index measure of bacterial diversity based on the wound cultures

Consider the number of bacterial species present, alongside the relative abundance of each specie across study arms.

Time frame: Within 1 year of injury date

Presence of bacterial species commonly attributed to surgical site infections based on would cultures including: Staph, enterococcus, acinetobacter, enterobacter, e. coli, klebsiella, and pseudomonas

Understand the changes that occur in the presence of bacterial species associated with surgical site infection after antibiotic powder treatment .

Time frame: Within 1 year of injury date

Acute Application of Antibiotic Powder in Open Fracture Wounds

Overview

Conditions

Interventions

Eligibility

Locations (2)

Outcomes

Primary Outcomes

Secondary Outcomes