The Use of a Platform Wound Device for Reducing Infection
1 other identifier
interventional
48
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Feb 2021
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 8, 2021
CompletedStudy Start
First participant enrolled
February 8, 2021
CompletedFirst Posted
Study publicly available on registry
February 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 19, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 25, 2022
CompletedOctober 14, 2022
October 1, 2022
9 months
February 8, 2021
October 12, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
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.
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.
48 to 96 hours
Secondary Outcomes (1)
Effectiveness of wound swabs
48 to 96 hours
Study Arms (2)
Platform wound device with antibiotic
EXPERIMENTALAntibiotic cream will be applied to study wounds and then dressed with the platform wound device.
Standard of Care
NO INTERVENTIONStudy wounds will be treated per the standard of care.
Interventions
Treatment of wounds with gentamycin and covered with platform wound device.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Baptist Medical Center
San Antonio, Texas, 78205, United States
North East Baptist Hospital
San Antonio, Texas, 78217, United States
Mission Trail Baptist Hospital
San Antonio, Texas, 78235, United States
North Central Baptist Hospital
San Antonio, Texas, 78258, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 8, 2021
First Posted
February 15, 2021
Study Start
February 8, 2021
Primary Completion
November 19, 2021
Study Completion
May 25, 2022
Last Updated
October 14, 2022
Record last verified: 2022-10