The Use of a Platform Wound Device for Reducing Infection
Primary Purpose
Wounds and Injury, Burn Wound, Infection Wound
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Gentamycin with Platform Wound Device
Sponsored by
About this trial
This is an interventional treatment trial for Wounds and Injury
Eligibility Criteria
Inclusion Criteria:
- Age greater or equal to 18 and age less than or equal to 85
- Open wound up to 500cm2 in area with evidence of infection
- Exposure of deep dermis, subcutaneous tissue, muscle, fascia, tendon, or bone
Exclusion Criteria:
- Pregnancy
- Prisoner
- Active malignancy, steroid use, or immunosuppressive therapy
- Open fracture intimately involved with wound
- Underlying osteomyelitis
- Hardware or prosthetic exposure within wound
- Exposure of major named vessels or nerves
- Known allergy to gentamicin or other aminoglycosides
Sites / Locations
- Baptist Medical Center
- North East Baptist Hospital
- Mission Trail Baptist Hospital
- North Central Baptist Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Platform wound device with antibiotic
Standard of Care
Arm Description
Antibiotic cream will be applied to study wounds and then dressed with the platform wound device.
Study wounds will be treated per the standard of care.
Outcomes
Primary Outcome Measures
Feasibility of treatment
Demonstration of the ability to enroll patients at a single institution to either the control group, receiving standard of care, or the treatment group, receiving PWD delivery and 1 dose of antibiotic (0.1% gentamicin cream) over 48 to 96 hours.
Tolerability of treatment
To demonstrate that patients are able to tolerate application of the PWD with 0.1% gentamicin cream application. Tolerability will be assessed by documentation of adverse events.
Secondary Outcome Measures
Effectiveness of wound swabs
To demonstrate that wound swabs are an accurate and reliable measurement of infection based on semi-quantitative wound culture results.
Full Information
NCT ID
NCT04753723
First Posted
February 8, 2021
Last Updated
October 12, 2022
Sponsor
The Metis Foundation
1. Study Identification
Unique Protocol Identification Number
NCT04753723
Brief Title
The Use of a Platform Wound Device for Reducing Infection
Official Title
The Use of a Platform Wound Device for Reducing Infection in Torso and Extremity Wounds: An Interventional Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
February 8, 2021 (Actual)
Primary Completion Date
November 19, 2021 (Actual)
Study Completion Date
May 25, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Metis Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will evaluate the safety and efficacy of a novel Platform Wound Device (PWD) in its delivery of a local antibiotic, 0.1% 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 wound(s) 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 1,2,3 and 4. All data collected of the study participants will be used to evaluate the PWD delivery of antibiotic.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wounds and Injury, Burn Wound, Infection Wound
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Platform wound device with antibiotic
Arm Type
Experimental
Arm Description
Antibiotic cream will be applied to study wounds and then dressed with the platform wound device.
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
Study wounds will be treated per the standard of care.
Intervention Type
Combination Product
Intervention Name(s)
Gentamycin with Platform Wound Device
Intervention Description
Treatment of wounds with gentamycin and covered with platform wound device.
Primary Outcome Measure Information:
Title
Feasibility of treatment
Description
Demonstration of the ability to enroll patients at a single institution to either the control group, receiving standard of care, or the treatment group, receiving PWD delivery and 1 dose of antibiotic (0.1% gentamicin cream) over 48 to 96 hours.
Time Frame
48 to 96 hours
Title
Tolerability of treatment
Description
To demonstrate that patients are able to tolerate application of the PWD with 0.1% gentamicin cream application. Tolerability will be assessed by documentation of adverse events.
Time Frame
48 to 96 hours
Secondary Outcome Measure Information:
Title
Effectiveness of wound swabs
Description
To demonstrate that wound swabs are an accurate and reliable measurement of infection based on semi-quantitative wound culture results.
Time Frame
48 to 96 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age greater or equal to 18 and age less than or equal to 85
Open wound up to 500cm2 in area with evidence of infection
Exposure of deep dermis, subcutaneous tissue, muscle, fascia, tendon, or bone
Exclusion Criteria:
Pregnancy
Prisoner
Active malignancy, steroid use, or immunosuppressive therapy
Open fracture intimately involved with wound
Underlying osteomyelitis
Hardware or prosthetic exposure within wound
Exposure of major named vessels or nerves
Known allergy to gentamicin or other aminoglycosides
Facility Information:
Facility Name
Baptist Medical Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78205
Country
United States
Facility Name
North East Baptist Hospital
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78217
Country
United States
Facility Name
Mission Trail Baptist Hospital
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78235
Country
United States
Facility Name
North Central Baptist Hospital
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78258
Country
United States
12. IPD Sharing Statement
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The Use of a Platform Wound Device for Reducing Infection
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