Superficial Partial-Thickness Burn Study

Overview

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 Title of Study: “Randomized Controlled Trial Assessing a Novel Glycopolymer Compound in the Treatment of Superficial Partial-thickness Burns”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 8, 2022

Detailed 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.

Interventions

  • Device: Catasyn™ Advanced Technology Hydrogel and SynePure™ Wound Cleanser
    • 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.
  • Drug: Silver Sulfadiazine
    • Silver sulfadiazine, a sulfa drug, is used to prevent and treat infections in burn wounds.

Arms, Groups and Cohorts

  • Active Comparator: Silver sulfadiazine
    • 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.
  • Experimental: Catasyn™ Advanced Technology Hydrogel and SynePure™ Wound Cleanser
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Number of Days to Healing of the Superficial Partial Thickness Burn Wound.
    • Time Frame: up to 21 days
    • 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)
  • Change From Screening Visit to Visit 8 in Total Patient and Observer Scar Assessment Scale (POSAS) Score
    • Time Frame: up to 21 days
    • 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 sections are then summed together to make up the total score (maximum of 120 and minimum of 12). Please note the means listed denote the difference in POSAS score between the baseline and last assessment completed (21 days if last visit completed, or earlier visit if withdrawn or lost to follow up).

Secondary Measures

  • Safety- Infection Rate From Screening Visit to Visit 8
    • Time Frame: up to 21 days
    • Safety as measured by total incidences of infection from screening visit to visit 8, or to last visit completed, for the three lost to follow up participants, and 1 participant who was withdrawn.
  • Safety- Rate of Noted Wound Progression From Screening Visit to Visit 8
    • Time Frame: up to 21 days
    • Safety as measured by total incidence of progression of burn wounds to deep partial thickness/full thickness from screening visit to visit 8, or to last visit completed, for the three lost to follow up participants, and 1 participant who was withdrawn.
  • Safety- Rate of Complications From Screening Visit to Visit 8
    • Time Frame: up to 21 days
    • 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, or to last visit completed, for the three lost to follow up participants, and 1 participant who was withdrawn.
  • Safety- as Measured by Change in Total Vancouver Scar Scale Score From Screening Visit to Visit 8, or to Last Visit Completed, for the Three Lost to Follow up Participants, and 1 Participant Who Was Withdrawn.
    • Time Frame: up to 21 days
    • 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. The means listed represent the difference in total score from baseline to 21 days, or from baseline to last assessment, if participant did not complete the 21 day visit.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • J. Peter Rubin, MD
  • Collaborator
    • Synedgen, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: J. Peter Rubin, MD, Endowed Chair of Plastic Surgery – University of Pittsburgh
  • Overall Official(s)
    • J. Peter Rubin, MD, Principal Investigator, University of Pittsburgh

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