Superficial Partial-Thickness Burn Study

J. Peter Rubin, MD

Status and phase: Terminated; Phase 4

Conditions: Superficial Partial Thickness Burn

Treatments: Drug: Silver Sulfadiazine; Device: Catasyn™ Advanced Technology Hydrogel and SynePure™ Wound Cleanser

Study type: Interventional

Funder types: Other; Other U.S. Federal agency; Industry

Identifiers

NCT04601532

STUDY20050205

Details and patient eligibility

About

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)

Full description

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.

Enrollment: 26 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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26 participants in 2 patient groups

Silver sulfadiazine

Active Comparator group

Description:

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.

Treatment:

Drug: Silver Sulfadiazine

Catasyn™ Advanced Technology Hydrogel and SynePure™ Wound Cleanser

Experimental group

Description:

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.

Treatment:

Device: Catasyn™ Advanced Technology Hydrogel and SynePure™ Wound Cleanser