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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03564795
Study type Interventional
Source KeraNetics, LLC
Contact Alexis Rejeski Gabard, MS
Phone 336-575-2278
Email alexis.gabard@keranetics.com
Status Recruiting
Phase N/A
Start date August 31, 2018
Completion date October 31, 2022

See also
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Terminated NCT03190655 - Efficacy and Safety of Aluminaid Versus Hydrogel Wound Dressings N/A
Withdrawn NCT03613870 - PermeaDerm® vs. Mepilex-Ag® in Promoting Healing of Partial-thickness Burn Wounds N/A
Completed NCT04880655 - A Randomized Trial Evaluating EARLY Application of a Surfactant Dressing in Thermal Injury (EARLY) N/A
Completed NCT02519621 - NPWT PRO vs KCI Ulta® NPWT and to Compare NPWT PRO vs NPWT PRO With Simultaneous Irrigation on Wound Healing N/A