26 Participants Needed

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

PS
ES
Overseen ByEleanor Shirley, MA, CCRC
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: J. Peter Rubin, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

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.

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.12345

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.12367

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.12356

Who Is on the Research Team?

JP

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
See 7 more

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?
2Treatment groups
Experimental Treatment
Active Control
Group I: Catasyn™ Advanced Technology Hydrogel and SynePure™ Wound CleanserExperimental Treatment1 Intervention
Group II: Silver sulfadiazineActive Control1 Intervention

Find a Clinic Near You

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.
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

Hydrogel burn dressing effectiveness in burn pain. [2023]
Combined Silver Sulfadiazine Nanosuspension with Thermosensitive Hydrogel: An Effective Antibacterial Treatment for Wound Healing in an Animal Model. [2023]
3.United Arab Emiratespubmed.ncbi.nlm.nih.gov
Honey-based Silver Sulfadiazine Microsponge-Loaded Hydrogel: In vitro and In vivo Evaluation for Burn Wound Healing. [2023]
Prospective clinical study of Hydron, a synthetic dressing, in delivery of an antimicrobial drug to second-degree burns. [2019]
Healing of burn wounds by topical treatment: A randomized controlled comparison between silver sulfadiazine and nano-crystalline silver. [2020]
Silver sulfadiazine loaded breathable hydrogel sponge for wound healing. [2021]
Evaluation of genipin-crosslinked chitosan hydrogels as a potential carrier for silver sulfadiazine nanocrystals. [2022]
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