Clinical trial NCT05877638: SWC for Treatment of Superficial Partial-Thickness Burns
Official title: Randomized Controlled Trial Assessing a Novel Glycopolymer Compound in the Treatment of Superficial Partial-Thickness Burns
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Burn Wounds
Lead sponsor: Synedgen, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Louisiana State University Health Sciences Center in New Orleans
First posted: 2023-05-26
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of healing wound progress across study window
timeFrame: Up to 21days
Secondary outcomes:
measure: Number of new infection rates
timeFrame: Up to 21days
Other outcomes:
measure: Number of complications other than infection
timeFrame: Up to 21days
Locations:
city: New Orleans
country: United States
facility: Louisiana State University Health Science Center at New Orleans
state: Louisiana
Study officials:
affiliation: Synedgen, Inc.
name: Shenda Baker, PhD
role: PRINCIPAL_INVESTIGATOR
References: