Actively Recruiting
Post-operative Topical Administration of FS2 to Evaluate Safety and Scarring in Skin Grafts and Donor Sites of Burn Patients
Led by Birch BioMed Inc · Updated on 2026-05-04
70
Participants Needed
2
Research Sites
3 weeks
Total Duration
On this page
Sponsors
B
Birch BioMed Inc
Lead Sponsor
N
Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating how a cream containing kynurenic acid, called FS2, affects scar formation in people with burn injuries who need skin graft surgery. This study aims to understand whether FS2 is safe and helpful in reducing scarring at both the skin graft and donor sites after surgery. The trial is a double-blind, randomized study with some parts masked to both patients and investigators. Participants will use either a control cream without FS2 or a treatment cream containing 0.5% FS2 on the donor and graft sites for the first 90 days without knowing which they receive. After this period, all participants will apply the FS2 cream openly for an additional 90 days. The study includes detailed photography and scar assessments using tools like POSAS and VSS at multiple time points. During the study, participants will have their graft and donor sites regularly examined and scored for scar condition up to Day 180. Quality of life will also be assessed using the Burn Specific Health Scale-Brief (BSHS-B). The study includes various visits for assessments, and safety and scar improvement are carefully monitored. Total participation may last around six months, with interim analyses planned to guide study direction.
CONDITIONS
Brief Title
Post-Operative Use of FS2 to Mitigate Scarring in Burn Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Medically able and willing to consent/assent to study requirements
- Male and female burn patients
- Aged 12 to 65 years (inclusive)
- Able to understand study requirements and consent without a translator; legally authorized representative may consent if applicable
- Body mass index (BMI) between 15 and 35 kg/m2 (inclusive)
- Clinically acceptable safety laboratory results as judged by the investigator
- Full thickness burn injury requiring partial thickness skin graft (meshed or sheet) excluding face and genitalia
- Skin graft size between 50 cm2 and 800 cm2 (after meshing if applicable)
- If graft is meshed, maximum expansion ratio of 1:1.5
- Able to apply study creams as instructed, by self or caregiver
You will not qualify if you...
- Unable to consent to study requirements
- Skin graft site located on face or genitalia
- Graft or donor site not fully healed at baseline
- Medically unstable during study and for 1 month after
- Pregnant or trying to become pregnant
- Participated in another interventional clinical trial within 3 months or currently enrolled in a trial
- Severe ongoing or prolonged depression or mental illness within past year
- Smoking more than 20 cigarettes daily
- History of heavy alcohol use in past month
- History of substance abuse within past 12 months
- Severe inhalation injury needing high oxygen, renal failure needing dialysis, or unstable blood pressure at treatment start
- Scarring, tattoos, birthmarks, or moles within 5 cm of treatment sites
- History of abnormal keloid scarring
- Other illnesses that may impair wound healing such as cancer, immune disorders, uncontrolled HIV, rheumatoid arthritis, kidney or liver failure, heart failure, or diabetes
- Chronic or active skin disorders affecting healing like psoriasis, dermatitis, or eczema
- History of radiotherapy to the scar area
- Known sensitivity to study cream ingredients
- Any other condition or limitation interfering with participation
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - Up to 180 days
Participants apply a topical cream to their skin graft and donor sites. For the first 90 days, participants use either the control cream or the FS2 cream in a blinded manner. After 90 days, all participants use the FS2 cream openly for another 90 days.
Assessment visits at Day 0, Day 28, Day 60, Day 90, Day 120, and Day 180
Trial Site Locations
Total: 2 locations
1
University of Alberta, Division of Plastic Surgery
Edmonton, Alberta, Canada, T6G 2B7
Actively Recruiting
2
Centre for Burn Research - Hamilton Health Sciences
Hamilton, Ontario, Canada, L8L 2X2
Actively Recruiting
Research Team
A
Adam Kuttenkeuler
S
Stephanie Recker
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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