SWC for Treatment of Superficial Partial-Thickness Burns

• Status: Recruiting
• Trial end date: 2024-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Synedgen, Inc.
• Collaborator: Louisiana State University Health Sciences Center in New Orleans
• Treatments: Silver Sulfadiazine; Sulfadiazine

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.