Anti-Bacterial Agents, Extremity Fracture Lower, Extremity Fractures Upper, Fractures, Bone, Fractures, Open, Wounds and Injuries--Infections
Conditions
Keywords
Open fractures, Antibiotic powder, Vancomycin, Tobramycin, Infection, Gustilo, 16S
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.
Interventions
DRUGVancomycin
1 vial of Vancomycin 1g powder applied topically to the open fracture wound injury.
DRUGTobramycin
1 vial of Tobramycin 1.2g powder applied topically to the open fracture wound injury.
Sponsors
University of Colorado, Denver
Denver Health and Hospital Authority
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Masking description
This will be a single-blind study as only the participants will be blinded to the treatment.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Surgical Site Infection During the Post-operative Follow-up Period | 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
| Measure | Time frame | Description |
|---|---|---|
| Presence of Fracture Nonunion | Within 1 year of injury date | Understand the changes that occur in nonunion after antibiotic powder treatment . |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORNicholas Alfonso, MD
University of Colorado, Denver
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 46.14 Years STANDARD_DEVIATION 11.27 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) White | 13 Participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 4 | 0 / 7 |
| other Total, other adverse events | 0 / 7 | 0 / 4 | 0 / 7 |
| serious Total, serious adverse events | 0 / 7 | 0 / 4 | 0 / 7 |
Outcome results
None listed