Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Davis
Dates
study started
completion around

Description

Summary

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.

Details

This phase 2 pilot study will assess the safety and efficacy of topical MW-III on thermal burns.

Keywords

Burns, Burns, Partial Thickness Burns, Sulfadiazine, Silver Sulfadiazine, Investigational Drug, MW-III, Silvadene® Cream 1% [Silver Sulfadiazine]

Eligibility

You can join if…

Open to people ages 18 years and up

  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.

You CAN'T join if...

  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.

Locations

  • University of CA Davis Medical Center accepting new patients
    Sacramento California 95817 United States
  • Valleywise Health Medical Center accepting new patients
    Phoenix Arizona 85008 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Skingenix, Inc.
ID
NCT01297400
Phase
Phase 2 Burns Research Study
Study Type
Interventional
Participants
Expecting 60 study participants
Last Updated