Superficial Partial-Thickness Burn Study
Condition: Superficial Partial Thickness Burn
MeSH terms: Burns
Intervention: Catasyn™ Advanced Technology Hydrogel and SynePure™ Wound Cleanser; Silver Sulfadiazine
Intervention description: Catasyn™ Advanced Technology Hydrogel is a wound hydrogel that provides a moist wound environment. A moist wound environment is supportive to wound healing. SynePure™ Wound Cleanser is a non-cytotoxic wound cleanser for the removal of foreign material from epidermal and dermal wounds, burns, cuts, abrasions and minor irritations of the skin.; Silver sulfadiazine, a sulfa drug, is used to prevent and treat infections in burn wounds.
Intervention MeSH terms: Sulfadiazine; Silver Sulfadiazine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 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).
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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)
    

Eligibility 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