Superficial Partial-Thickness Burn Study

Study Overview
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Brief Summary
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This study is an investigator initiated, single site, University of Pittsburgh, prospective, parallel group, randomized controlled trial comparing SynePure Wound Cleanser and Catasyn Advanced Technology Hydrogel (intervention group) to the current gold standard treatment Silvadene (control group). Both groups will receive the same care other than the treating agent. Subjects will be recruited form the UPMC Mercy Burn Center adult patient pool who have sustained superficial partial-thickness burn wounds that comprise less than or equal to 10% of total body surface area (TBSA)

Detailed Description
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Current effective dressings 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.

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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Superficial Partial Thickness Burn

Intervention / Treatment
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* Device: Catasyn™ Advanced Technology Hydrogel and SynePure™ Wound Cleanser
* Drug: Silver Sulfadiazine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ability to provide informed consent 18 years of age or older, male and female Patients who have sustained superficial, partial-thickness burn wounds ≤ to 10% of total body surface area (TBSA) 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 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 ≥ to 48 hours prior to entry into the UPMC Mercy Burn Center Clinic. Patients with uncontrolled cerebrovascular disease, cardiovascular disease, endocrine disease, hepatic disease, or renal disease; or other severe conditions for whom, in the physician 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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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
Interventional Model Description: This study is an investigator initiated, single site, University of Pittsburgh, prospective, parallel group, randomized controlled trial comparing SynePure Wound Cleanser and Catasyn Advanced Technology Hydrogel (intervention group) to the current gold standard treatment Silvadene (control group).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Silver sulfadiazine<br>Topical management via dressings provide a barrier against microbial infection. The current gold standard for burn wound dressings is silver (nanoparticulate or ionic), and it has shown some efficacy in treating infections, but it does not demonstrate an ability to prevent infections and some treatment guidelines even recommend against its use. Although silver dressing is preferred for military use, a retrospective review spanning 10 years of use in military environments showed that silver was not more effective than other antimicrobial topical treatments, and a meta-analysis with over 2500 surgical patients found silver sulfadiazine was associated with increased infection rates and hospital length-of-stays were two days longer on average. | Drug: Silver Sulfadiazine<br>* Silver sulfadiazine, a sulfa drug, is used to prevent and treat infections in burn wounds.<br>* Other names: Silvadene Topical Product;|
| Experimental: Catasyn™ Advanced Technology Hydrogel and SynePure™ Wound Cleanser<br>Synedgen has developed Catasyn™ Advanced Technology Hydrogel and SynePure™ Wound Cleanser. These products are Food and Drug Administration (FDA) 510(k) cleared wound care medical devices, formulated with a novel biocompatible chitosan derivative, poly (acetyl, arginyl) glucosamine. SynePure™ Wound Cleanser is optimized for the cleansing and debridement of wounds and thermal injuries, and Catasyn™ Advanced Technology Hydrogel serves as a protective gel dressing. Together, these products reduce inflammation in wounds, aggregate bacteria and disrupt bacterial biofilms, and accelerate healing. | Device: Catasyn™ Advanced Technology Hydrogel and SynePure™ Wound Cleanser<br>* Catasyn™ Advanced Technology Hydrogel is a wound hydrogel that provides a moist wound environment. A moist wound environment is supportive to wound healing. SynePure™ Wound Cleanser is a non-cytotoxic wound cleanser for the removal of foreign material from epidermal and dermal wounds, burns, cuts, abrasions and minor irritations of the skin.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from screening visit to visit 8, in healing of the superficial partial thickness burn wound | Number of days to healed burn wound (re-epithelialization as defined by greater than or equal to 90% epithelialized wound, determined by investigator exam and review of wound photographs, as needed) | up to 21 days | 
| Change from screening visit to visit 8 in total Patient and Observer Scar Assessment Scale (POSAS) score | The patient and observer scar assessment scale (POSAS) is used to measure scar quality. It is composed of a patient reported section and an observer reported section (6 scored items each). Each section consists of items on a ten-step scale (1= as normal skin to 10=very different from normal skin/worst scar imaginable). A higher score indicates more symptoms/issues present; the lower the score the closer to normal skin. These are then summed together to make up the total score (maximum of 60 and minimum of 6 for each section). | up to 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety- infection rate from screening visit to visit 8 | Safety as measured by total incidences of infection from screening visit to visit 8 | up to 21 days | 
| Safety- rate of noted wound progression from screening visit to visit 8 | Safety as measured by total incidence of progression of burn wounds to deep partial thickness/full thickness from screening visit to visit 8 | up to 21 days | 
| Safety- rate of complications from screening visit to visit 8 | Safety as measured by rate of adverse event/complication that resulted in a change to the participant's treatment course from initial standard of care from screening visit to visit 8 | up to 21 days | 
| Safety- as measured by change in total Vancouver Scar Scale Score from screening visit to visit 8 | Vancouver Scar Scale Score: The VSS is a scale to assess the extent of scarring for a given wound by scoring the pigmentation, vascularity, pliability and height of the scar. Each domain is individually scored then the domains are summed to give a total score that range from zero (0) to 13 with zero (0) representing a 'normal' presentation. Validity and reliability of the scale have been documented and is commonly used in wound healing research. | up to 21 days |