Actively Recruiting
Post-Operative Use of FS2 to Mitigate Scarring in Burn Patients
Led by Birch BioMed Inc · Updated on 2026-05-04
70
Participants Needed
2
Research Sites
25 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
The goal of this study is to see how an ingredient called kynurenic acid (which we named "FS2") affects scar formation in people with burn injuries that need skin graft surgery. A cream with FS2 will be used on both the area where the skin graft was placed and the area where the skin was taken (donor site). The cream will be applied after the skin has healed. This study will help us understand if FS2 is safe and effective for mitigating skin scar formation in burn patients.
CONDITIONS
Official 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 or assent to study requirements
- Male and female burn patients
- Aged between 12 and 65 years (inclusive)
- Able to understand study requirements and consent without a translator; legally authorized representative can consent if applicable
- Body mass index (BMI) between 15 and 35 kg/m2 (inclusive)
- Clinically acceptable safety laboratory test results as determined by the investigator
- Full thickness burn injury requiring partial thickness skin graft (meshed or sheet) at any location except face and genitalia
- Skin graft size between 50 cm2 and 800 cm2 after meshing if applicable
- Maximum skin graft expansion ratio of 1:1.5 if the graft is meshed
- Able to apply the investigational products as instructed, personally or with caregiver help
You will not qualify if you...
- Medically unable to consent to study requirements
- Skin graft or donor sites located on the face or genitalia
- Treatment sites that have not fully re-epithelialized at baseline
- Expected medical instability during the study and one month after
- Pregnant or attempting to become pregnant
- Participation in another interventional clinical trial within 3 months prior or ongoing
- Clinical evidence of severe or prolonged depression or mental illness within the past year
- Smoking more than 20 cigarettes daily
- History of heavy drinking in the past month (over 14 drinks/week for men or over 7 drinks/week for women)
- History of substance abuse within 12 months prior to screening
- Severe inhalation injury requiring high oxygen support, renal failure needing dialysis, or unstable blood pressure requiring vasopressors at treatment start
- Scarring near treatment sites from previous interventions or conditions like tattoos, birthmarks, or moles within 5 cm
- History of abnormal keloid scarring
- Concurrent illnesses affecting wound healing such as cancer, immune disorders, uncontrolled infections, heart failure, or diabetes
- Chronic or active skin disorders affecting wound healing such as psoriasis, dermatitis, or eczema
- Previous radiotherapy to the scar area
- Known sensitivity to any components of the investigational products
- Any other medical, physical, or geographical condition limiting participation
AI-Screening
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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
CONTACT
S
Stephanie Recker
CONTACT
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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