SWC for Treatment of Superficial Partial-Thickness Burns

Burn Wounds Clinical Trial

Official title:

Randomized Controlled Trial Assessing a Novel Glycopolymer Compound in the Treatment of Superficial Partial-Thickness Burns

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05877638
• Other study ID #: SWC
• Status: Recruiting
• Phase: N/A
• Start date: March 27, 2023
• Est. completion date: August 2024

Study information

• Verified date: May 2024
• Source: Synedgen, Inc.
• Contact: Shenda Baker, PhD
• Phone: (909) 447-6858
• Email: sb[@]synedgen.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to test the safety and effectiveness of SynePure™ Wound Cleanser when used in combination with Catasyn™ Advanced Technology Hydrogel for the treatment of superficial partial-thickness burn wounds.

Description:

Current management options for burn wounds contain silver (nanoparticulate or ionic), hypochlorite, hydrogen peroxide, sulfa agents, chlorhexidine, iodine or other dilute antiseptics meant to provide some measure of antimicrobial protection. However, all of these materials have some proven limitations in facilitating wound healing and also have notable local and systemic adverse effects. None of the current clinical treatments enhance healing and/or reduce scar formation. The purpose of this study is to test the safety and effectiveness of SynePure™ Wound Cleanser when used in combination with Catasyn™ Advanced Technology Hydrogel for the treatment of superficial partial-thickness burn wounds.

This study is a prospective, parallel group, randomized controlled trial comparing SynePure Wound Cleanser and Catasyn Advanced Technology Hydrogel (intervention group) to routine care, Silvadene (control group). Both groups will receive the same care other than the treating agent. Subjects will be recruited from the Burn Center/Clinic adult patient pool who have sustained superficial partial-thickness burn wounds that comprise ≤15% of total body surface area (TBSA).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 115
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients who have sustained superficial, partial thickness burn wounds no less than 5% and up to 15% of total body surface area (TBSA; 5-15%). Contiguous superficial and deep partial-thickness burns are eligible for inclusion.

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

Exclusion Criteria:

• Inability to provide informed consent

• Deep partial-thickness burns except as noted in the inclusion criteria and full-thickness burns

• Radiation, chemical or electrical burn injury

• Patients with burns primarily located to the face, genitals, or span across joints

• Patients whose burn injury was = 8 days prior to entry into the Burn Center/ Clinic.

• Patients with uncontrolled cerebrovascular disease, cardiovascular disease, concurrent endocrine, hepatic or renal disease, or other severe conditions for whom, in the investigators' discretion would render study participation unsafe

• Patients with documented or self-reported shellfish allergies

• Current pregnancy

• Patients with concurrent burn related injuries or inhalation injury that would put the patient at increased risk, per physician discretion

• Any condition to which in the investigator's discretion would render study enrollment a safety concern for the patient.

Related Conditions & MeSH terms

• Burn Wounds
• Burns

Intervention

Device:
• SynePure Wound Cleanser and Catasyn Advanced Technology Hydrogel
(FDA) 510(k) cleared wound care medical devices formulated with a novel biocompatible chitosan derivative, poly (acetyl, arginyl) glucosamine. SynePure is optimized for the cleansing and debridement of wounds and thermal injuries, and Catasyn serves as a protective gel dressing.

Drug:
• SILVADENE Cream 1% (silver sulfadiazine)
SILVADENE Cream 1% (silver sulfadiazine) is a topical antimicrobial drug indicated as an adjunct for the prevention and treatment of wound sepsis in patients with second- and third-degree burns.

Locations

Country	Name	City	State
United States	Louisiana State University Health Science Center at New Orleans	New Orleans	Louisiana

Sponsors (2)

Lead Sponsor	Collaborator
Synedgen, Inc.	Louisiana State University Health Sciences Center in New Orleans

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of complications other than infection	Complications such as gangrene, necrosis, periwound dermatitis and/or edema, hematoma, or any other complication determined to be related to the wound and/or treatment	Up to 21days
Primary	Percentage of healing wound progress across study window	Healing is defined as 90% re-epithelialization (skin and mucous membrane replacement) of the wounded area	Up to 21days
Secondary	Number of new infection rates	Characterized by local new inflammation, heat, purulence as well as new or increased pain, redness and swelling	Up to 21days