Ignite Creation Date:
2024-05-06 @ 3:47 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04753723
Status:
COMPLETED
Last Update Posted:
2022-10-14
First Post:
2021-02-08
Brief Title:
The Use of a Platform Wound Device for Reducing Infection
Sponsor:
The Metis Foundation
Organization:
The Metis Foundation
Study Overview
Official Title:
The Use of a Platform Wound Device for Reducing Infection in Torso and Extremity Wounds An Interventional Clinical Trial
Status:
COMPLETED
Status Verified Date:
2022-10
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:
None
Brief Summary:
This study will evaluate the safety and efficacy of a novel Platform Wound Device PWD in its delivery of a local antibiotic 01 Gentamycin cream to prevent or treat infection in torso and extremity wounds The hypothesis is that the PWD will be a safe and effective method to provide topical antibiotics to a torso or extremity wound non-inferior to the current standard of care This treatment will reduce or rapidly eradicate infection
Detailed Description:
This is a prospective randomized controlled clinical trial comparing the use of a platform wound device as compared to standard of care to prevent or eliminate infection in torso and extremity wounds Patients 18-85 years of age admitted for treatment of open wounds will be screened for inclusion criteria and asked to consent to participate in the randomized study The first 10 patients will be treated with the PWD gentamicin and will serve as a safety subset Baseline measurement of serum antibiotic concentraion will be taken prior to PWD placement and one day after Following the safety subset 50 patients will be randomized to standard of care or to a single application of the PWD gentamicin Baseline assessments will be completed on day 0 including screening pre-procedure wound evaluation imaging assessments and specimen collection Follow-up assessments will be completed and data gathered at days 123 and 4 All data collected of the study participants will be used to evaluate the PWD delivery of antibiotic
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None