Ignite Creation Date:
2024-05-06 @ 4:06 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04872400
Status:
COMPLETED
Last Update Posted:
2024-02-05
First Post:
2021-04-29
Brief Title:
Acute Application of Antibiotic Powder in Open Fracture Wounds
Sponsor:
University of Colorado Denver
Organization:
University of Colorado Denver
Study Overview
Official Title:
Acute Application Of Intrawound Antibiotic Powder In Open Extremity Fracture Wounds
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
APOW
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5672 | OTHER_GRANT | Orthopaedic Trauma Association | None |