Superficial Partial-Thickness Burn Study

Last updated: January 4, 2024
Sponsor: J. Peter Rubin, MD
Overall Status: Terminated

Phase

4

Condition

Skin Wounds

Hyponatremia

Treatment

Silver Sulfadiazine

Catasyn™ Advanced Technology Hydrogel and SynePure™ Wound Cleanser

Clinical Study ID

NCT04601532
STUDY20050205
  • Ages > 18
  • All Genders

Study 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)

Eligibility Criteria

Inclusion

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% oftotal body surface area (TBSA)
  • Patients otherwise in good general physical and mental health, as per theinvestigator's clinical judgment

Exclusion

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 BurnCenter Clinic.
  • Patients with uncontrolled cerebrovascular disease, cardiovascular disease, endocrinedisease, hepatic disease, or renal disease; or other severe conditions for whom, inthe 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 thepatient at increased risk, per physician discretion
  • Any condition to which in the investigator's discretion would render study enrollmenta safety concern for the patient

Study Design

Total Participants: 26
Treatment Group(s): 2
Primary Treatment: Silver Sulfadiazine
Phase: 4
Study Start date:
June 11, 2021
Estimated Completion Date:
December 08, 2022

Study 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.

Connect with a study center

  • UPMC Mercy Hospital

    Pittsburgh, Pennsylvania 15219
    United States

    Site Not Available

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