Catasyn™ Advanced Technology Hydrogel and SynePure™ Wound Cleanser for Superficial Burns

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Superficial BurnsCatasyn™ Advanced Technology Hydrogel and SynePure™ Wound Cleanser - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is comparing two burn wound treatments to see which is better. One group will use Silvadene and the other will use SynePure Wound Cleanser and Catasyn Advanced Technology Hydrogel.

Eligible Conditions
  • Superficial Burns

Treatment Effectiveness

Study Objectives

2 Primary · 4 Secondary · Reporting Duration: up to 21 days

up to 21 days
Change from screening visit to visit 8 in total Patient and Observer Scar Assessment Scale (POSAS) score
Change from screening visit to visit 8, in healing of the superficial partial thickness burn wound
Safety- as measured by change in total Vancouver Scar Scale Score from screening visit to visit 8
Safety- infection rate from screening visit to visit 8
Safety- rate of complications from screening visit to visit 8
Safety- rate of noted wound progression from screening visit to visit 8

Trial Safety

Trial Design

2 Treatment Groups

Silver sulfadiazine
1 of 2
Catasyn™ Advanced Technology Hydrogel and SynePure™ Wound Cleanser
1 of 2

Active Control

Experimental Treatment

115 Total Participants · 2 Treatment Groups

Primary Treatment: Catasyn™ Advanced Technology Hydrogel and SynePure™ Wound Cleanser · No Placebo Group · Phase 4

Catasyn™ Advanced Technology Hydrogel and SynePure™ Wound Cleanser
Device
Experimental Group · 1 Intervention: Catasyn™ Advanced Technology Hydrogel and SynePure™ Wound Cleanser · Intervention Types: Device
Silver sulfadiazine
Drug
ActiveComparator Group · 1 Intervention: Silver Sulfadiazine · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 21 days

Who is running the clinical trial?

Synedgen, Inc.Industry Sponsor
United States Department of DefenseFED
779 Previous Clinical Trials
202,304 Total Patients Enrolled
Synedgen, IncUNKNOWN
J. Peter Rubin, MDLead Sponsor
3 Previous Clinical Trials
27 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are able to provide informed consent.
You are otherwise in good general physical and mental health.
You are 18 years of age or older, male or female.
References