Superficial Partial-Thickness Burn Study

Phase 4

Terminated

Conditions: Superficial Partial Thickness Burn

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

Registration Number: NCT04601532

Lead Sponsor: J. Peter Rubin, MD

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 26

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Catasyn™ Advanced Technology Hydrogel and SynePure™ Wound Cleanser	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.
Silver sulfadiazine	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.

Primary Outcome Measures

Name	Time	Method
Number of Days to Healing of the Superficial Partial Thickness Burn Wound.	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	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 Outcome Measures

Name	Time	Method
Safety- Rate of Complications From Screening Visit to Visit 8	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- Rate of Noted Wound Progression From Screening Visit to Visit 8	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- Infection Rate From Screening Visit to Visit 8	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- 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.	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.