Effectiveness of KeraStat Gel for Improved Cosmesis of Partial Thickness Burns
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Partial Thickness Burn
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Randomized, controlled within-subject trial of 30 patients, each of whom will have a minimum of one burn treated with the KeraStat Gel device and one burn treated with the standard of care dressingMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 6 years and 100 years
- Gender
- Both males and females
Description
The study seeks to determine whether the use of KeraStat Gel as the primary dressing for partial thickness burns results in improved cosmesis of the healed wound, and results in less painful dressing changes, faster reepithelialization, and reduction in need for excision and grafting. The study will...
The study seeks to determine whether the use of KeraStat Gel as the primary dressing for partial thickness burns results in improved cosmesis of the healed wound, and results in less painful dressing changes, faster reepithelialization, and reduction in need for excision and grafting. The study will enroll 30 subjects. The study design is a randomized, controlled, within-subject trial to compare the effectiveness of KeraStat Gel vs. standard of care (SOC), silver sulfadiazine (SSD). Each of two distinct burns will be randomized to the use of KeraStat Gel or SOC. Patients will be seen weekly for the first month and then at months 3, 6, and 12 post burn.
Tracking Information
- NCT #
- NCT03564795
- Collaborators
- Wake Forest University
- United States Department of Defense
- Investigators
- Principal Investigator: James H Holmes IV, MD Wake Forest Burn Center
Get Well Soon