Catasyn™ Hydrogel + SynePure™ Cleanser and Silver Sulfadiazine for Superficial Burns

Overseen By Eleanor Shirley, MA, CCRC

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: J. Peter Rubin, MD

Disqualifiers: Deep burns, Chemical burns, Cardiovascular disease, Shellfish allergies, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 11

Duration: 3 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new wound care treatment for people with superficial burns (top layer skin burns). The study compares a combination of Catasyn™ Hydrogel and SynePure™ Cleanser against the current standard treatment, silver sulfadiazine (a topical antibiotic cream). The goal is to determine if the new combination speeds up healing and reduces infection. People with superficial burns covering 10% or less of their body may be suitable candidates. As a Phase 4 trial, this research involves an FDA-approved treatment and aims to understand its benefits for more patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What is the safety track record for Catasyn™ Advanced Technology Hydrogel, SynePure™ Wound Cleanser, and Silver Sulfadiazine?

Research has shown that Catasyn™ Advanced Technology Hydrogel and SynePure™ Wound Cleanser are safe for use. The FDA has approved these products for treating wounds, confirming they meet safety standards. They are designed to reduce swelling, fight germs, and promote faster wound healing without causing harm.

Studies have demonstrated that hydrogels, like Catasyn™, and silver sulfadiazine, used for burns, can reduce pain and keep wounds clean. No reports of serious side effects have emerged when using Catasyn™ and SynePure™ together, indicating they are well-tolerated by individuals with skin injuries. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard of care for superficial burns, which often involves silver sulfadiazine, Catasyn™ Advanced Technology Hydrogel and SynePure™ Wound Cleanser bring something new to the table. Researchers are excited about these treatments because they are formulated with a novel chitosan derivative that not only protects wounds but also reduces inflammation and disrupts bacterial biofilms. This dual-action approach helps accelerate healing and could potentially offer a faster, more effective recovery. Additionally, these treatments aggregate bacteria, making it easier to remove them during wound cleaning.

What evidence suggests that Catasyn™ Hydrogel and SynePure™ Cleanser could be effective for superficial burns?

Research has shown that hydrogels, such as Catasyn™, can reduce pain and inhibit bacterial growth in burn wounds. In this trial, participants may receive a combination of Catasyn™ and SynePure™ Cleanser, designed to clean and protect wounds, promoting faster healing. Studies have found that this combination reduces swelling, collects bacteria, and breaks down bacterial clusters in burns, suggesting it might outperform traditional methods. Another arm of this trial uses silver sulfadiazine, which has been associated with more infections and longer hospital stays. These findings support the potential of Catasyn™ and SynePure™ as promising options for treating minor burns. ^{3 5 6 7 8}

Who Is on the Research Team?

J. Peter Rubin, MD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

Inclusion Criteria

Ability to provide informed consent

Patients otherwise in good general physical and mental health, as per the investigator's clinical judgment

Patients who have sustained superficial, partial-thickness burn wounds ≤ to 10% of total body surface area (TBSA)

Exclusion Criteria

Patients whose burn injury was ≥ to 48 hours prior to entry into the UPMC Mercy Burn Center Clinic.

Current pregnancy

Inability to provide informed consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment

Participants receive either SynePure Wound Cleanser and Catasyn Advanced Technology Hydrogel or Silvadene for up to 21 days

3 weeks

8 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including scar assessment and infection rate

3 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Catasyn™ Advanced Technology Hydrogel and SynePure™ Wound Cleanser
• Silver Sulfadiazine

How Is the Trial Designed?

Group I: Catasyn™ Advanced Technology Hydrogel and SynePure™ Wound Cleanser Experimental Treatment 1 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 sulfadiazine Active Control 1 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.

Who Is Running the Clinical Trial?

J. Peter Rubin, MD

Lead Sponsor

Trials

4

Recruited

50+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Synedgen, Inc.

Industry Sponsor

Trials

3

Recruited

130+

Synedgen, Inc

Collaborator

Trials

1

Recruited

30+

Published Research Related to This Trial

In a clinical trial involving 27 patients with second-degree burns, a synthetic dressing (Hydron-AgSD) demonstrated a significant reduction in the need for dressing changes compared to standard silver sulfadiazine treatment, enhancing patient comfort.

The synthetic dressing effectively prevented bacterial contamination in most cases, while healing rates were similar to those of traditional dressings, suggesting it may offer both safety and efficacy in managing burn wounds.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective clinical study of Hydron, a synthetic dressing, in delivery of an antimicrobial drug to second-degree burns. Fang, CH., Nathan, P., Robb, EC., et al.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04601532

Superficial Partial-Thickness Burn Study This study is an investigator initiated, single site, University of Pittsburgh, prospective, parallel group, randomized controlled trial comparing SynePure ...

2. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/32/NCT04601532/Prot_SAP_ICF_000.pdf

Randomized Controlled Trial Assessing a Novel Glycopolymer ... SynePure Wound Cleanser and Catasyn Advanced Technology Wound Hydrogel compares to the standard of care (Silvadene) in terms of safety and effectiveness.

3. synedgen.com synedgen.com/synedgen-initiates-clinical-trial-assessing-combination-of-synepure-and-catasyn-for-the-treatment-of-partial-thickness-burns/

Synedgen Initiates Clinical Trial Assessing Combination of ... “We believe the combination of our two wound care products is not only safe but improves time-to-heal and infection rates in superficial partial ...

4. withpower.com withpower.com/trial/phase-4-burns-5-2021-e3a94

Catasyn™ Hydrogel + SynePure™ Cleanser and Silver ... Research shows that hydrogels and silver sulfadiazine are effective in reducing pain and preventing bacterial contamination in burn wounds. A study found that ...

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05877638/swc-for-treatment-of-superficial-partial-thickness-burns

SWC for Treatment of Superficial Partial-Thickness Burns The purpose of this study is to test the safety and effectiveness of SynePure™ Wound Cleanser when used in combination with Catasyn™ Advanced ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04601532

NCT04601532 | Superficial Partial-Thickness Burn Study The purpose of this study is to test the safety and effectiveness of SynePure™ Wound Cleanser when used in combination with Catasyn™ Advanced Technology ...

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf17/K172338.pdf

February 21, 2018 Synedgen, Inc Shenda Baker President ... Catasyn may be used under the direction of a health care professional for the dressing and management of partial to full thickness dermal ulcers ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT04601532?intr=SILVADENE&aggFilters=studyType:int&viewType=Table&rank=7&tab=results

Study Results | Superficial Partial-Thickness Burn Study Synedgen has developed Catasyn™ Advanced Technology Hydrogel and SynePure™ Wound Cleanser. These products are Food and Drug Administration (FDA) 510(k) cleared ...