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

26 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Catasyn™ Hydrogel + SynePure™ Cleanser and Silver Sulfadiazine for superficial burns?

Research shows that hydrogels and silver sulfadiazine are effective in reducing pain and preventing bacterial contamination in burn wounds. A study found that hydrogels can provide better pain relief compared to silver sulfadiazine alone, and another study highlighted the antibacterial benefits of silver sulfadiazine when used in a hydrogel form. ^{1 2 3 4 5}

Is the combination of Catasyn™ Hydrogel, SynePure™ Cleanser, and Silver Sulfadiazine safe for treating superficial burns?

Silver sulfadiazine is commonly used for burn wounds due to its antibacterial properties, but it can cause inflammation and cell toxicity. Studies have explored combining it with hydrogels to improve safety and effectiveness, suggesting that these combinations may be safer than using silver sulfadiazine alone. ^{1 2 3 5 6}

How does the Catasyn™ Hydrogel + SynePure™ Cleanser and Silver Sulfadiazine treatment differ from other burn treatments?

This treatment is unique because it combines Catasyn™ Advanced Technology Hydrogel and SynePure™ Wound Cleanser with silver sulfadiazine, which is known for its antibacterial properties. The hydrogel component may help in reducing pain and improving healing by keeping the wound moist, while the silver sulfadiazine provides broad-spectrum antibacterial protection, potentially enhancing the overall effectiveness compared to using silver sulfadiazine alone. ^{1 2 3 4 7}

Research Team

J. Peter Rubin, MD

Principal Investigator

University of Pittsburgh

Eligibility Criteria

Inclusion Criteria

Ability to provide informed consent

18 years of age or older, male and female

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

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

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)

Treatment Details

Interventions

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

Participant Groups

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+

Findings from Research

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Hydrogel burn dressing effectiveness in burn pain. [2023]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Combined Silver Sulfadiazine Nanosuspension with Thermosensitive Hydrogel: An Effective Antibacterial Treatment for Wound Healing in an Animal Model. [2023]

3. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Honey-based Silver Sulfadiazine Microsponge-Loaded Hydrogel: In vitro and In vivo Evaluation for Burn Wound Healing. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Prospective clinical study of Hydron, a synthetic dressing, in delivery of an antimicrobial drug to second-degree burns. [2019]

5. India pubmed.ncbi.nlm.nih.gov

Healing of burn wounds by topical treatment: A randomized controlled comparison between silver sulfadiazine and nano-crystalline silver. [2020]

6. Germany pubmed.ncbi.nlm.nih.gov

Silver sulfadiazine loaded breathable hydrogel sponge for wound healing. [2021]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Evaluation of genipin-crosslinked chitosan hydrogels as a potential carrier for silver sulfadiazine nanocrystals. [2022]