The Use of a Platform Wound Device for Reducing Infection

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Use of a Platform Wound Device for Reducing Infection in Torso and Extremity Wounds: An Interventional Clinical Trial

Conditions
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Wounds and Injury, Burn Wound, Infection Wound

Intervention / Treatment
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* Combination Product: Gentamycin with Platform Wound Device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Platform wound device with antibiotic<br>Antibiotic cream will be applied to study wounds and then dressed with the platform wound device. | Combination Product: Gentamycin with Platform Wound Device<br>* Treatment of wounds with gentamycin and covered with platform wound device.<br>|
| No Intervention: Standard of Care<br>Study wounds will be treated per the standard of care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of wound swabs | To demonstrate that wound swabs are an accurate and reliable measurement of infection based on semi-quantitative wound culture results. | 48 to 96 hours |