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KeraStat Gel for Partial Thickness Burns

N/A
Waitlist Available
Led By James H Holmes IV, MD
Research Sponsored by KeraNetics, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up entire study (one year)
Awards & highlights

Study Summary

This trial looks at whether KeraStat Gel improves the appearance of healed wounds, compared to the standard silver sulfadiazine.

Eligible Conditions
  • Partial Thickness Burns

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year post burn
This trial's timeline: 3 weeks for screening, Varies for treatment, and one year post burn for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Improved Cosmesis
Secondary outcome measures
Need for Excision and Grafting
Medical dressing
Time to Reepithelialization

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: KeraStat GelExperimental Treatment1 Intervention
Each enrolled subject will have at least one eligible burn randomized to the KeraStat Gel arm. This burn will be dressed with KeraStat Gel and covered by a secondary dressing. Subjects will be instructed to change the dressing and re-apply the KeraStat Gel per the instructions for use (at least every 3 days).
Group II: Silver SulfadiazineActive Control1 Intervention
Each enrolled subject will have at least one eligible burn randomized to the Silver Sulfadiazine arm. This burn will be dressed with the Silver Sulfadiazine and covered by a secondary dressing. Subjects will be instructed to change the dressing and re-apply the Silver Sulfadiazine per the institution's Standard of Care instructions.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
KeraStat Gel
2019
N/A
~30

Find a Location

Who is running the clinical trial?

KeraNetics, LLCLead Sponsor
3 Previous Clinical Trials
75 Total Patients Enrolled
Wake Forest UniversityOTHER
189 Previous Clinical Trials
164,550 Total Patients Enrolled
United States Department of DefenseFED
861 Previous Clinical Trials
227,164 Total Patients Enrolled

Frequently Asked Questions

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Recent research and studies
~5 spots leftby Apr 2025