Superficial Partial-Thickness Burn Study

Phase 4TerminatedNCT04601532

J. Peter Rubin, MD26 enrolled

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)

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Superficial Partial Thickness Burn

Interventions

Catasyn™ Advanced Technology Hydrogel and SynePure™ Wound CleanserDEVICE

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.

Silver SulfadiazineDRUG

Silver sulfadiazine, a sulfa drug, is used to prevent and treat infections in burn wounds.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

UPMC Mercy Hospital

Pittsburgh, Pennsylvania, United States

Outcomes

Primary Outcomes

Number of Days to 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)

Time frame: 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 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).

Time frame: up to 21 days

Secondary Outcomes

Safety- Infection Rate From Screening Visit to Visit 8

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.

Time frame: 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, 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

Safety- Rate of Complications From Screening Visit to Visit 8

Data from ClinicalTrials.gov

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