Clinical Safety and Scar Prevention Study of a Topical Antifibrotic Compound FS2. (FS2)
Scar, Cicatrix, Hypertrophic Scar
About this trial
This is an interventional prevention trial for Scar
Eligibility Criteria
Inclusion Criteria:
- Medically able to consent to study requirements
- Adult, male and female trauma patients
- Ages 18 to 65 years of age
- Fluent in English (able to consent without a translator)
- Isolated skin wound of 3% Total Body Surface Area
- Participant requires partial thickness skin graft (meshed/non-meshed), face and genitalia excluded.
- Grafted skin is between 100 cm2 and 600 cm2
- Maximum skin graft expansion ratio is 1:1.5
Exclusion Criteria:
- Medically unable to consent to study requirements
- Require an English translator to lawfully consent to the study and its requirements
- Treatment sights (skin graft sights) located on the face and genitalia
- Expected to be medically unstable for the duration of the study period and an additional 1-month thereafter
- Pregnant, or attempting to become pregnant
- Known immunosuppression or immunosuppressive illness
- Subjects who had taken part in a clinical trial within 3 months prior to admission to this trial or who are currently participating in a clinical trial, whether an investigational drug was used or not.
- Subjects who had any clinical evidence of severe ongoing or prolonged depression or mental illness
- Subjects who smoke more than 20 cigarettes a day
- Subjects who demonstrated evidence of drug abuse
- Any other diagnosis, condition, physical or geographical limitation with the participant that may render, or increases the likelihood of rendering, him/her unable to complete the entire study.
Sites / Locations
- VGH Burn UnitRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Sham Comparator
Experimental
Experimental
Sham Comparator
Experimental
Experimental
Donor Site Wound, Vehicle
Donor Site Wound, FS2 0.25
Donor Site Wound, FS2 0.5
Skin Graft Wound, Vehicle
Skin Graft Wound, FS2 0.25
Skin Graft Wound, FS2 0.5
A vehicle moisturizing cream base applied to a bisected area of the donor site wound (from where the skin graft skin harvested).
A moisturizing cream base containing 0.25%w/w of FS2, applied to a bisected area of the donor site wound (from where the skin graft skin harvested).
A moisturizing cream base containing 0.50%w/w of FS2, applied to a bisected area of the donor site wound (from where the skin graft skin harvested)
A vehicle moisturizing cream base applied to a bisected area of the skin grafted wound site.
A moisturizing cream base containing 0.25%w/w of FS2, applied to a bisected area of the skin grafted wound site.
A moisturizing cream base containing 0.50%w/w of FS2, applied to a bisected area of the skin grafted wound site.