The goal of this randomized controlled clinical trial is to determine whether use of Kericis Intact Fish Skin Graft (IFSG) can decrease the amount of autograft tissue needed for treatment of deep partial-thickness burns in patients at least 18 years of age with a deep partial-thickness burn for whom autograft treatment is clinically indicated. This clinical trial seeks to collect the following: 1. Difference in the percentage area of the IFSG treatment site and control autograft treatment site that required autografting within 1 month of treatment 2. Proportion of subjects achieving durable wound closure of the IFSG treatment site without autograft placement within 2 months of treatment 3. Difference in cosmesis between the IFSG treatment site and autograft treatment site a year after treatment 4. Difference in the pain intensity between the IFSG treatment site and autograft treatment site Each participant will receive autograft and intact fish skin graft (IFSG) on different areas of their deep partial-thickness burn. Participants will be assessed for the need for further autograft treatment. Participants will also be assessed for wound closure, pain, and cosmesis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
65
Treatment with IFSG
Treatment with autograft
Loyola University Medical Center
Maywood, Illinois, United States
Difference in percentage area of the IFSG treatment site and control autograft treatment site that required autografting by 1 month.
Time frame: From initial surgical IFSG/autograft treatment post-enrollment to 28 +/- 3 days later
Proportion of subjects achieving durable wound closure of the intact fish skin treatment site at Month 2 without autograft placement
Time frame: From initial treatment with IFSG/autograft post-enrollment to 60 +/- 7 days later
Difference in cosmesis between the IFSG treatment site and autograft treatment site at Month 12 based on observer POSAS total score
Scar quality will be assessed using the Patient and Observer Scar Assessment Scale (POSAS) that describes scar quality on a scale from 1-10 with 1 being a scar very similar to normal skin and 10 being a severe scar very unlike normal skin.
Time frame: From initial treatment with IFSG/autograft post-enrollment to 365 +/- 30 days later
Difference in the pain intensity between the IFSG treatment site and autograft treatment site one week after treatment based on the Wong-Baker FACES pain rating scale (FPRS)
The Wong-Baker FACES pain rating scale presents a range of faces with a happy face associated with a score of 0, meaning "no hurt", to a very sad face associated with a score of 10, meaning "hurts worst."
Time frame: From initial treatment with IFSG/autograft post-enrollment to 7 +/- 1 days later
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