Recruiting NCT01297400
Phase 2 Pilot Study of the Safety and Efficacy of Topical MW-III in Thermal Burns
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Investigational Drug, MW-III, Silvadene® Cream 1% [Silver Sulfadiazine].
- Who it may be relevant to
- Registry conditions: Burns. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Mexico
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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.
Detailed description
This phase 2 pilot study will assess the safety and efficacy of topical MW-III on thermal burns.
Interventions
- Drug Investigational Drug, MW-III
Topical application, twice a day - Drug Silvadene® Cream 1% [Silver Sulfadiazine]
Topical application, twice a day
Primary outcome measures
- Time to healing (≥95% re-epithelialization) of the partial thickness target burn. [Time frame: 28 days Treatment Period]
Secondary outcome measures (3)
- Proportion of subjects with partial thickness burns that are healed at each scheduled study assessment. [Time frame: 28 days Treatment Period]
- Proportion of subjects with partial thickness burns determined by PI to require skin grafting of burn wound by Day 28. [Time frame: 28 days Treatment Period]
- Scar scores (POSAS) of the partial thickness target burn and all other partial thickness burns at Day 28. [Time frame: 28 days Treatment Period]
Eligibility criteria
Inclusion criteria
- Adults, 18 years of age or older on the day of signing the informed consent.
- 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.
- Able and willing to give informed consent and comply with study procedures.
Exclusion criteria
- Any burn that at screening is:
- infected.
- circumferential or deemed, in the judgment of the investigator, at high risk for developing compartment syndrome.
- partial thickness that is likely, in the judgment of the Investigator, to require grafting within 72 hours, or other non-protocol intervention.
- Severe inhalation injury or other significant non-burn trauma.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 4 centers
- Valleywise Health Medical Center — Phoenix
- University of CA Davis Medical Center — Sacramento
- MedStar Washington Hospital Center — Washington D.C.
- University of Iowa Health Care — Iowa City
Mexico · 2 centers
- Proactive CR Mexico SA de CV — Irapuato
- SMIQ S de R. L de CV — Querétaro City
Identifiers
NCT: NCT01297400 · MW-III-BURN-2-001