A Study to Investigate Two Atteris Antimicrobial Products on Chronic Wound Healing.

Study Overview
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Brief Summary
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This is a 2-part pilot study to determine the clinical effectiveness of two new antimicrobial products on the complete healing of chronic wounds.

Detailed Description
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Part 1 of this study will involve 5 patients with qualified chronic wounds which will receive active treatment with both the Atteris Antimicrobial Skin and Wound Cleanser (AWC) and the Atteris Antimicrobial Barrier Film Dressing (ABFD) for a 6-week period with a 12 week follow-up in order to optimize the final study application protocols. Part 2 of this study is a randomized, double blind, 2 by 2 factorial, controlled study comparing the AWC and/or the ABFD with 100 research subjects and n=25 subjects per cell. Patients will be randomized to receive either active AWC and active ABFD, or active AWD and placebo ABFD, or placebo AWC and active ABFC, or AWC placebo and ABFD placebo in addition to standard of care (SOC). The active AWC active ABFD versus AWC placebo ABFD placebo statistical contrast will be of most importance and the clinical expectation is wounds treated with the active forms of these products will heal faster than wounds treated with double placebo and this will additionally provide data to power a future definitive study to compare the healing potential of the two therapeutic modalities (AWC, ABFD).

Official Title
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2-part, Randomized, Double Blind, Prospective, Single Center, Controlled Trial to Investigate an Antimicrobial Skin and Wound Cleanser and an Antimicrobial Barrier Film Dressing on the Rates of Healing for Chronic Wounds

Conditions
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Chronic Wounds

Intervention / Treatment
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* Device: Atteris Antimicrobial Skin and Wound Cleanser
* Device: Atteris Antimicrobial Barrier Film Dressing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female between the ages of 18 and 89 If IDDM or NIDDM, glycosylated hemoglobin, HgbA1c, ≤10% Presence of chronic Wound of any etiology between 0.5 cm2 and 15 cm2, inclusive, post debridement Wound has been present for at least 4 weeks, but not greater than 52 weeks at time of screening Non-surgical wounds which meet the clinical definition of chronic between 0.5 cm2 and 15 cm2 Adequate arterial perfusion of the affected limb, defined as at least one of the following: Ankle-brachial index (ABI) ≥0.7 and ≤1.2 Dorsum transcutaneous oxygen test ≥ 30 mm Hg Biphasic or triphasic Doppler waveforms at screening Patient and/or caregiver have the ability and willingness to understand and comply with study procedures and give written, informed consent prior to enrollment in the study or initiation of study procedures. Exclusion Criteria: Suspected or confirmed signs/symptoms of active wound infection or gangrene Hyperbaric Oxygen Therapy, any duration, within the past 12 months Osteomyelitis Use of oral or IV antibiotic/antimicrobial agents within 2 days (48 hours) of baseline Subjects who have received growth factor therapy (e.g., autologous platelet-rich plasma gel, becaplermin,) within 28 days of screening Subjects who have received dermal substitutes (e.g. Integra, collagen, micronized cadaver skin, bilayered cell therapy, dermal substitute, extracellular matrix etc.) within 28 days of screening. Pyoderma gangrenosum, or Reynaud's disease Wound with necrotic tissue covered with slough or eschar that cannot be debrided Chronic wounds with exposed bone Wounds with fistulas or deep sinus tracks of unknown depth Active Charcot foot on the study limb Receiving hemodialysis or peritoneal dialysis History of malignancy excluding non-melanoma skin cancer Treatment with radiation or chemotherapy within 3 months of screening Known immunosuppression, excluding diabetes mellitus Receiving (within 30 days of enrollment) or scheduled to receive a medication or treatment which is known to affect wound healing, such as systemic steroids (such as daily prednisone), immunosuppressive therapy, radiation or chemotherapy of any kind, autoimmune disease therapy or cytostatic therapy Subjects with known alcohol or substance abuse within 6 months of screening Subjects with known allergy to PHMB, acrylate polymer and silicone Pregnancy or breastfeeding at time of screening Participation in another investigational device, drug, or biological trial that may interfere with results within 6 months of screening

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 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: Factorial Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active AWC + Active ABFD<br>Active Antimicrobial Wound Cleanser + Active Antimicrobial Barrier Film Dressing + SOC | Device: Atteris Antimicrobial Skin and Wound Cleanser<br>* Wounds will be cleansed with either the experimental wound cleanser or a placebo and will then be covered with standard of care wound dressings.<br>Device: Atteris Antimicrobial Barrier Film Dressing<br>* Wounds will be covered with either the experimental barrier film dressing or a placebo and will then be covered with standard of care wound dressings.<br>|
| Experimental: Active AWC + Placebo ABFD<br>Active Antimicrobial Wound Cleanser + Placebo Antimicrobial Barrier Film Dressing + SOC | Device: Atteris Antimicrobial Skin and Wound Cleanser<br>* Wounds will be cleansed with either the experimental wound cleanser or a placebo and will then be covered with standard of care wound dressings.<br>Device: Atteris Antimicrobial Barrier Film Dressing<br>* Wounds will be covered with either the experimental barrier film dressing or a placebo and will then be covered with standard of care wound dressings.<br>|
| Experimental: Placebo AWC + Active ABFD<br>Placebo Antimicrobial Wound Cleanser + Active Antimicrobial Barrier Film Dressing + SOC | Device: Atteris Antimicrobial Skin and Wound Cleanser<br>* Wounds will be cleansed with either the experimental wound cleanser or a placebo and will then be covered with standard of care wound dressings.<br>Device: Atteris Antimicrobial Barrier Film Dressing<br>* Wounds will be covered with either the experimental barrier film dressing or a placebo and will then be covered with standard of care wound dressings.<br>|
| Experimental: Placebo AWC + Placebo ABFD<br>Placebo Antimicrobial Wound Cleanser + Placebo Antimicrobial Barrier Film Dressing + SOC | Device: Atteris Antimicrobial Skin and Wound Cleanser<br>* Wounds will be cleansed with either the experimental wound cleanser or a placebo and will then be covered with standard of care wound dressings.<br>Device: Atteris Antimicrobial Barrier Film Dressing<br>* Wounds will be covered with either the experimental barrier film dressing or a placebo and will then be covered with standard of care wound dressings.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete Closure | Did the chronic wounds achieve complete closure as defined by 100% epithelialization requiring no additional treatment? (YES or NO) | 6 weeks of active treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infective episodes | The number of infective episodes for which oral or IV antibiotics are prescribed | 6 weeks | 
| Pain | Pain as reported using a Wong Baker Scale | 6 weeks | 
| Wound Dimension Decreases | The percentage change in wound size relative to the baseline measurement | 6 and 12 weeks |