SWC for Treatment of Superficial Partial-Thickness Burns

Last updated: November 27, 2024
Sponsor: Synedgen, Inc.
Overall Status: Terminated

Phase

N/A

Condition

Hyponatremia

Skin Wounds

Treatment

SILVADENE Cream 1% (silver sulfadiazine)

SynePure Wound Cleanser and Catasyn Advanced Technology Hydrogel

Clinical Study ID

NCT05877638
SWC
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients who have sustained superficial, partial thickness burn wounds no less than 5% and up to 15% of total body surface area (TBSA; 5-15%). Contiguous superficialand deep partial-thickness burns are eligible for inclusion.

  • 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 except as noted in the inclusion criteria andfull-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 ≥ 8 days prior to entry into the Burn Center/ Clinic.

  • Patients with uncontrolled cerebrovascular disease, cardiovascular disease,concurrent endocrine, hepatic or renal disease, or other severe conditions for whom,in the 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 putthe patient at increased risk, per physician discretion

  • Any condition to which in the investigator's discretion would render studyenrollment a safety concern for the patient.

Study Design

Total Participants: 2
Treatment Group(s): 2
Primary Treatment: SILVADENE Cream 1% (silver sulfadiazine)
Phase:
Study Start date:
March 27, 2023
Estimated Completion Date:
June 20, 2024

Study Description

Current management options 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.

This study is a prospective, parallel group, randomized controlled trial comparing SynePure Wound Cleanser and Catasyn Advanced Technology Hydrogel (intervention group) to routine care, Silvadene (control group). Both groups will receive the same care other than the treating agent. Subjects will be recruited from the Burn Center/Clinic adult patient pool who have sustained superficial partial-thickness burn wounds that comprise ≤15% of total body surface area (TBSA).

Connect with a study center

  • Louisiana State University Health Science Center at New Orleans

    New Orleans, Louisiana 70112
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.