MedTrace Logo

Effectiveness of KeraStat Gel for Improved Cosmesis of Partial Thickness Burns

NCT03564795 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2024-08-01

Study results available
· View outcomes & findings →

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.

Conditions

  • Partial-thickness Burn

Interventions

DEVICE

KeraStat Gel

Wound dressing for partial thickness burns

DEVICE

Silver Sulfadiazine

Wound dressing for partial thickness burns

Sponsors & Collaborators

  • Wake Forest University

    collaborator OTHER

  • United States Department of Defense

    collaborator FED

  • KeraNetics, LLC

    lead INDUSTRY

Principal Investigators

  • James H Holmes IV, MD · Wake Forest Burn Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-31
Primary Completion
2023-03-31
Completion
2023-03-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03564795 on ClinicalTrials.gov