Phase 2 Pilot Study of the Safety and Efficacy of Topical MW-III in Thermal Burns

Description

To compare MW-III to Silvadene® Cream 1% (Silver Sulfadiazine) with respect to "time to healing" (≥95% re-epithelialization) of a partial thickness target thermal burn.

Conditions

Burns

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Study Overview

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Study Details

Study overview

To compare MW-III to Silvadene® Cream 1% (Silver Sulfadiazine) with respect to "time to healing" (≥95% re-epithelialization) of a partial thickness target thermal burn.

Phase 2 Pilot Study of the Safety and Efficacy of Topical MW-III in Thermal Burns

Phase 2 Pilot Study of the Safety and Efficacy of Topical MW-III in Thermal Burns

Condition
Burns
Intervention / Treatment

-

Contacts and Locations

Phoenix

Valleywise Health Medical Center, Phoenix, Arizona, United States, 85008

Sacramento

University of CA Davis Medical Center, Sacramento, California, United States, 95817

Washington

MedStar Washington Hospital Center, Washington, District of Columbia, United States, 20010

Augusta

Joseph M. Still Burn Center, Doctor's Hospital, Augusta, Georgia, United States, 30909

New Orleans

University Medical Center New Orleans, New Orleans, Louisiana, United States, 70112

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Adults, 18 years of age or older on the day of signing the informed consent.
  • 2. Thermal Burns not exceeding a total body surface area (TBSA) OF 25%, with at least one partial thickness burn of 0.5% TBSA or greater. If full thickness burn(s) are present at screening, the total full thickness burn area shall not exceed 10% TBSA. Note: TBSA excludes areas of superficial (first degree) burns.
  • 3. Able and willing to give informed consent and comply with study procedures.
  • 1. Any burn that at screening is:
  • 1. infected.
  • 2. circumferential or deemed, in the judgment of the investigator, at high risk for developing compartment syndrome.
  • 3. partial thickness that is likely, in the judgment of the Investigator, to require grafting within 72 hours, or other non-protocol intervention.
  • 2. Severe inhalation injury or other significant non-burn trauma.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Skingenix, Inc.,

Kevin Foster, PRINCIPAL_INVESTIGATOR, Valleywise Health Medical Center

Study Record Dates

2024-12-22