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Catasyn™ Hydrogel + SynePure™ Cleanser and Silver Sulfadiazine for Superficial Burns
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.
- Superficial Burns
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Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- 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.
- Group 1: Silver sulfadiazine
- Group 2: Catasyn™ Advanced Technology Hydrogel and SynePure™ Wound Cleanser
- 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.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- 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
Are the FDA's regulations satisfied for Catasyn™ Advanced Technology Hydrogel and SynePure™ Wound Cleanser?
"With this being a Phase 4 trial, the safety rating for Catasyn™ Advanced Technology Hydrogel and SynePure™ Wound Cleanser is rated as 3 due to it's approval status."
How many individuals are recruited for participation in this experiment?
"Affirmative, the information on clinicaltrials.gov reveals that this trial is currently accepting volunteers. It was initially posted on June 11th 2021 and last modified on October 6th 2022. They are attempting to enrol 115 participants at a single facility."
What are the aims of this study?
"The primary metric for this trial, which has a duration of up to 21 days, is the change in Patient and Observer Scar Assessment Scale (POSAS) score from screening visit to visit 8. Additionally, safety will be measured by changes in Vancouver Scar Scale Score, rate of noted wound progression between visits 8 and 1, as well as infection incidences during that timeframe."
What empirical evidence has been gathered regarding the efficacy of Catasyn™ Advanced Technology Hydrogel and SynePure™ Wound Cleanser?
"Currently, there are 3 trials in progress for the Catasyn™ Advanced Technology Hydrogel and SynePure™ Wound Cleanser. None of which has reached Phase 3 yet. These tests are largely being held at 7 medical sites located in Pittsburgh, Pennsylvania."
Is this experimental procedure open to new participants?
"According to clinicaltrials.gov, this trial is presently enrolling subjects. It was first publicised on June 11th 2021 and recently updated on October 6th 2022."
In what contexts is Catasyn™ Advanced Technology Hydrogel and SynePure™ Wound Cleanser prescribed?
"Catasyn™ Advanced Technology Hydrogel and SynePure™ Wound Cleanser can both be employed to address serious ailments such as wound infections, third degree burns, and septicemia."
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