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Hydrogel
SWC + Hydrogel for Burns
N/A
Recruiting
Led By Shenda Baker, PhD
Research Sponsored by Synedgen, Inc.
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 21days
Awards & highlights
Study Summary
This trial tests a wound care product to see how safe and effective it is for burn wounds.
Who is the study for?
This trial is for individuals with good health who have superficial partial-thickness burns covering 5-15% of their body. It's not for those with radiation, chemical or electrical burns, shellfish allergies, pregnant women, or people with severe concurrent diseases. Burns shouldn't be on the face, genitals, across joints or older than 8 days.Check my eligibility
What is being tested?
The study tests SynePure Wound Cleanser combined with Catasyn Hydrogel against SILVADENE Cream to treat superficial partial-thickness burn wounds. The goal is to see which treatment is safer and more effective in healing these types of burns.See study design
What are the potential side effects?
Potential side effects may include allergic reactions to ingredients in the cleanser or hydrogel, skin irritation at the application site, and possible discomfort during use. Specific side effects will be monitored throughout the trial.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 21days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 21days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Healing wound progress
Secondary outcome measures
New infection rates
Other outcome measures
Complications other than infection
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: SynePure with CatasynExperimental Treatment1 Intervention
SynePure Wound Cleanser and Catasyn Advanced Technology Hydrogel
Group II: SilvadeneActive Control1 Intervention
Routine care wound rinse and Silvadene cream
Find a Location
Who is running the clinical trial?
Louisiana State University Health Sciences Center in New OrleansOTHER
114 Previous Clinical Trials
44,086 Total Patients Enrolled
Synedgen, Inc.Lead Sponsor
2 Previous Clinical Trials
126 Total Patients Enrolled
1 Trials studying Burns
26 Patients Enrolled for Burns
Shenda Baker, PhDPrincipal InvestigatorSynedgen, Inc.
1 Previous Clinical Trials
100 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am unable to understand and give consent for treatment.I have deep or full-thickness burns.I have had a burn injury from radiation, chemicals, or electricity.My burn injury happened more than 8 days before I went to the Burn Center.My burns are mainly on my face, genitals, or across my joints.I have burns covering 5-15% of my body, including both superficial and deep partial-thickness burns.
Research Study Groups:
This trial has the following groups:- Group 1: SynePure with Catasyn
- Group 2: Silvadene
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are allowed to take part in this research exploration?
"Affirmative. Clinicaltrials.gov attests to the fact that this trial is actively recruiting, having been initially posted on March 27th 2023 and last modified May 17th of the same year. 115 patients are sought from a single site for the study."
Answered by AI
Is this research venture open to new participants at present?
"Affirmative. Details published on clinicaltrials.gov disclose that this examination is currently searching for participants, having been announced March 27th 2023 and last updated May 17th 2023. The study requires 115 individuals to be recruited from 1 centre."
Answered by AI
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