SWC for Treatment of Superficial Partial-Thickness Burns

Randomized Controlled Trial Assessing a Novel Glycopolymer Compound in the 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 Technology Hydrogel for the treatment of superficial partial-thickness burn wounds.

Study Overview

• Status: Recruiting
• Conditions: Burn Wounds
• Intervention / Treatment: Device: SynePure Wound Cleanser and Catasyn Advanced Technology Hydrogel; Drug: SILVADENE Cream 1% (silver sulfadiazine)

Detailed 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).

• Study Type: Interventional
• Enrollment (Estimated): 115
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shenda Baker, PhD; Phone Number: (909) 447-6858; Email: sb@synedgen.com
• Study Contact Backup: Name: Kaveri Parker, PhD; Phone Number: (909) 447-6858; Email: kp@synedgen.com

Study Locations

• United States
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Recruiting
      • Louisiana State University Health Science Center at New Orleans
      • Contact: Shana Lennard, RN, CCRP; Phone Number: 504-702-5171; Email: slenna@lsuhsc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SynePure with Catasyn; SynePure Wound Cleanser and Catasyn Advanced Technology Hydrogel	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.
Active Comparator: Silvadene; Routine care wound rinse and Silvadene cream	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Healing wound progress	Healing is defined as 90% re-epithelialization (skin and mucous membrane replacement) of the wounded area	Up to 21days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
New infection rates	Characterized by local new inflammation, heat, purulence as well as new or increased pain, redness and swelling	Up to 21days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Synedgen, Inc.
• Collaborators: Louisiana State University Health Sciences Center in New Orleans
• Investigators: Principal Investigator: Shenda Baker, PhD, Synedgen, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2023
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): April 1, 2024

Study Registration Dates

• First Submitted: March 27, 2023
• First Submitted That Met QC Criteria: May 17, 2023
• First Posted (Actual): May 26, 2023

Study Record Updates

• Last Update Posted (Actual): May 26, 2023
• Last Update Submitted That Met QC Criteria: May 17, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Burns; Anti-Infective Agents, Local; Anti-Infective Agents; Anti-Bacterial Agents; Antiprotozoal Agents; Antiparasitic Agents; Coccidiostats; Sulfadiazine; Silver Sulfadiazine
• Other Study ID Numbers: SWC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes