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Catasyn™ Hydrogel + SynePure™ Cleanser and Silver Sulfadiazine for Superficial Burns
Phase 4
Waitlist Available
Research Sponsored by J. Peter Rubin, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 21 days
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
Summary
This trial tests a special wound cleaning solution and healing gel on adults with minor burns. The cleanser helps clean the burn, and the gel keeps it moist to improve healing.
Eligible Conditions
- Superficial Burns
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 21 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 21 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change From Screening Visit to Visit 8 in Total Patient and Observer Scar Assessment Scale (POSAS) Score
Number of Days to Healing of the Superficial Partial Thickness Burn Wound.
Secondary study objectives
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
+1 moreAwards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Catasyn™ Advanced Technology Hydrogel and SynePure™ Wound CleanserExperimental Treatment1 Intervention
Synedgen has developed Catasyn™ Advanced Technology Hydrogel and SynePure™ Wound Cleanser. These products are Food and Drug Administration (FDA) 510(k) cleared wound care medical devices, formulated with a novel biocompatible chitosan derivative, poly (acetyl, arginyl) glucosamine. SynePure™ Wound Cleanser is optimized for the cleansing and debridement of wounds and thermal injuries, and Catasyn™ Advanced Technology Hydrogel serves as a protective gel dressing. Together, these products reduce inflammation in wounds, aggregate bacteria and disrupt bacterial biofilms, and accelerate healing.
Group II: Silver sulfadiazineActive Control1 Intervention
Topical management via dressings provide a barrier against microbial infection. The current gold standard for burn wound dressings is silver (nanoparticulate or ionic), and it has shown some efficacy in treating infections, but it does not demonstrate an ability to prevent infections and some treatment guidelines even recommend against its use. Although silver dressing is preferred for military use, a retrospective review spanning 10 years of use in military environments showed that silver was not more effective than other antimicrobial topical treatments, and a meta-analysis with over 2500 surgical patients found silver sulfadiazine was associated with increased infection rates and hospital length-of-stays were two days longer on average.
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Who is running the clinical trial?
United States Department of DefenseFED
906 Previous Clinical Trials
333,344 Total Patients Enrolled
J. Peter Rubin, MDLead Sponsor
3 Previous Clinical Trials
27 Total Patients Enrolled
Synedgen, Inc.Industry Sponsor
2 Previous Clinical Trials
215 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have burns on your face, genitals, or joints.You have had a serious burn injury from radiation, chemicals, or electricity.You have severe burns that extend through multiple layers of your skin.You have uncontrolled problems with your brain, heart, hormones, liver, or kidneys. The study might not be safe for you if you have any other serious health conditions, as decided by the doctors.You have burns or injuries that affect your breathing, which may make participating in the study too risky according to the doctor.You have a known allergy to shellfish, either through medical documentation or personal experience.
Research Study Groups:
This trial has the following groups:- Group 1: Silver sulfadiazine
- Group 2: Catasyn™ Advanced Technology Hydrogel and SynePure™ Wound Cleanser
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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