NCT03564795

Effectiveness of KeraStat Gel for Improved Cosmesis of Partial Thickness Burns

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: KeraNetics, LLC · Industry
• Sex: All
• Age: 6 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

A randomized, controlled, 30-subject, within-subject trial for examining the effectiveness of KeraStat Gel, as opposed to the institutional standard of care, silver sulfadiazine, in improving cosmesis of the healed wound.

Detailed 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 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.

Conditions

• Partial-thickness Burn

Interventions

Type	Name	Description
DEVICE	KeraStat Gel	Wound dressing for partial thickness burns
DEVICE	Silver Sulfadiazine	Wound dressing for partial thickness burns

Timeline

• Start date: 2018-08-31
• Primary completion: 2023-03-31
• Completion: 2023-03-31
• First posted: 2018-06-21
• Last updated: 2024-08-01
• Results posted: 2024-08-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study