SWC for Treatment of Superficial Partial-Thickness Burns

Study Overview
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Brief Summary
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The purpose of this study is to test the safety and effectiveness of SynePure™ Wound Cleanser when used in combination with Catasyn™ Advanced Technology Hydrogel for the treatment of superficial partial-thickness burn wounds.

Detailed Description
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Current management options for burn wounds contain silver (nanoparticulate or ionic), hypochlorite, hydrogen peroxide, sulfa agents, chlorhexidine, iodine or other dilute antiseptics meant to provide some measure of antimicrobial protection. However, all of these materials have some proven limitations in facilitating wound healing and also have notable local and systemic adverse effects. None of the current clinical treatments enhance healing and/or reduce scar formation. The purpose of this study is to test the safety and effectiveness of SynePure™ Wound Cleanser when used in combination with Catasyn™ Advanced Technology Hydrogel for the treatment of superficial partial-thickness burn wounds. This study is a prospective, parallel group, randomized controlled trial comparing SynePure Wound Cleanser and Catasyn Advanced Technology Hydrogel (intervention group) to routine care, Silvadene (control group). Both groups will receive the same care other than the treating agent. Subjects will be recruited from the Burn Center/Clinic adult patient pool who have sustained superficial partial-thickness burn wounds that comprise ≤15% of total body surface area (TBSA).

Official Title
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Randomized Controlled Trial Assessing a Novel Glycopolymer Compound in the Treatment of Superficial Partial-Thickness Burns

Conditions
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Burn Wounds

Intervention / Treatment
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* Device: SynePure Wound Cleanser and Catasyn Advanced Technology Hydrogel
* Drug: SILVADENE Cream 1% (silver sulfadiazine)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who have sustained superficial, partial thickness burn wounds no less than 5% and up to 15% of total body surface area (TBSA; 5-15%). Contiguous superficial and deep partial-thickness burns are eligible for inclusion. Patients otherwise in good general physical and mental health, as per the investigator's clinical judgment. Exclusion Criteria: Inability to provide informed consent Deep partial-thickness burns except as noted in the inclusion criteria and full-thickness burns Radiation, chemical or electrical burn injury Patients with burns primarily located to the face, genitals, or span across joints Patients whose burn injury was ≥ 8 days prior to entry into the Burn Center/ Clinic. Patients with uncontrolled cerebrovascular disease, cardiovascular disease, concurrent endocrine, hepatic or renal disease, or other severe conditions for whom, in the investigators' discretion would render study participation unsafe Patients with documented or self-reported shellfish allergies Current pregnancy Patients with concurrent burn related injuries or inhalation injury that would put the patient at increased risk, per physician discretion Any condition to which in the investigator's discretion would render study enrollment a safety concern for the patient.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SynePure with Catasyn<br>SynePure Wound Cleanser and Catasyn Advanced Technology Hydrogel | Device: SynePure Wound Cleanser and Catasyn Advanced Technology Hydrogel<br>* (FDA) 510(k) cleared wound care medical devices formulated with a novel biocompatible chitosan derivative, poly (acetyl, arginyl) glucosamine. SynePure is optimized for the cleansing and debridement of wounds and thermal injuries, and Catasyn serves as a protective gel dressing.<br>|
| Active Comparator: Silvadene<br>Routine care wound rinse and Silvadene cream | Drug: SILVADENE Cream 1% (silver sulfadiazine)<br>* SILVADENE Cream 1% (silver sulfadiazine) is a topical antimicrobial drug indicated as an adjunct for the prevention and treatment of wound sepsis in patients with second- and third-degree burns.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Healing wound progress | Healing is defined as 90% re-epithelialization (skin and mucous membrane replacement) of the wounded area | Up to 21days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| New infection rates | Characterized by local new inflammation, heat, purulence as well as new or increased pain, redness and swelling | Up to 21days |