Superficial Partial-Thickness Burn Study

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is an investigator initiated, single site, University of Pittsburgh, prospective, parallel group, randomized controlled trial comparing SynePure Wound Cleanser and Catasyn Advanced Technology Hydrogel (intervention group) to the current gold standard treatment Silvadene (control group). Both groups will receive the same care other than the treating agent. Subjects will be recruited form the UPMC Mercy Burn Center adult patient pool who have sustained superficial partial-thickness burn wounds that comprise less than or equal to 10% of total body surface area (TBSA)

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: J. Peter Rubin, MD
• Collaborators: Synedgen, Inc; United States Department of Defense
• Treatments: Silver Sulfadiazine; Sulfadiazine

Criteria

Inclusion Criteria:

• Ability to provide informed consent

• 18 years of age or older, male and female

• Patients who have sustained superficial, partial-thickness burn wounds ≤ to 10% of total body surface area (TBSA)

• 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 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 ≥ to 48 hours prior to entry into the UPMC Mercy Burn Center Clinic.

• Patients with uncontrolled cerebrovascular disease, cardiovascular disease, endocrine disease, hepatic disease, or renal disease; or other severe conditions for whom, in the physician 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