Last updated: January 4, 2024
Sponsor: J. Peter Rubin, MD
Overall Status: Terminated
Phase
4
Condition
Skin Wounds
Hyponatremia
Treatment
Silver Sulfadiazine
Catasyn™ Advanced Technology Hydrogel and SynePure™ Wound Cleanser
Clinical Study ID
NCT04601532
STUDY20050205
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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% oftotal body surface area (TBSA)
- Patients otherwise in good general physical and mental health, as per theinvestigator's clinical judgment
Exclusion
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 BurnCenter Clinic.
- Patients with uncontrolled cerebrovascular disease, cardiovascular disease, endocrinedisease, hepatic disease, or renal disease; or other severe conditions for whom, inthe 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 thepatient at increased risk, per physician discretion
- Any condition to which in the investigator's discretion would render study enrollmenta safety concern for the patient
Study Design
Total Participants: 26
Treatment Group(s): 2
Primary Treatment: Silver Sulfadiazine
Phase: 4
Study Start date:
June 11, 2021
Estimated Completion Date:
December 08, 2022
Study Description
Connect with a study center
UPMC Mercy Hospital
Pittsburgh, Pennsylvania 15219
United StatesSite Not Available

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