Post-Operative Use of FS2 to Mitigate Scarring in Burn Pa... | NCT06807021

NCT06807021

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Name	Class
Nutrasource Pharmaceutical and Nutraceutical Services, Inc.	NETWORK

Description Module

Label	Type	Description	Intervention Names
Skin Grafted wound	Experimental	The wound site (injury)	Drug: IP1 control cream (Vehicle base) Drug: IP2 - 0.5% w/w FS2
Donor Skin Graft Harvest wound	Experimental	A Surgical wound	Drug: IP1 control cream (Vehicle base) Drug: IP2 - 0.5% w/w FS2

Name	Type	Description	Arm Group Labels	Other Names
IP1 control cream (Vehicle base)	Drug	Without FS2	Donor Skin Graft Harvest wound Skin Grafted wound

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Scar condition of the skin grafted wound on Day 90 as assessed by VSS	To evaluate the effect of 90-day FS2 cream use, compared to control, on clinician-assessed scar condition assessed by Vancouver Scar Scale (VSS) at the skin grafted wound (Study Arm 1)	90 days

Secondary Outcomes

Measure	Description	Time Frame
Scar condition of the donor skin graft harvest site on Day 90 as assessed by VSS	To evaluate the effect of 90-day FS2 cream use, compared to control, on clinician-assessed scar condition assessed by VSS at the donor skin graft harvest site (Study Arm 2)	90 days
Scar condition of the skin graft wound on Day 28 and Day 60 as assessed by VSS

Other Outcomes

Measure	Description	Time Frame
Scar size(cm2) at the skin grafted wound on Day 28, Day 60 and Day 90 as assessed by photographs	To evaluate the effect of 28-, 60-, and 90-day FS2 cream use, compared to control, on wound scarring from: skin grafted wound (Study Arm 1)	Day 28, Day 60 and Day 90
Scar height(cm) at the skin grafted wound on Day 28, Day 60 and Day 90 as assessed by photographs

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Medically able and willing to consent/assent to study requirements
Male and female burn patients
12 to 65 years of age (inclusive)
Able to understand the study requirements and consent without a translator. Where applicable, participant's legally authorized representative (LAR) is willing and able to agree to the requirements and restrictions of the study, be willing to give voluntary informed consent (or assent, if capable), be able to understand and read the questionnaires, carry out all study-related procedures, and communicate effectively with the study staff.
Have a BMI between 15 and 35 kg/m2 (inclusive)
Have clinically acceptable results in the safety laboratory tests as deemed by the investigator
Have full thickness burn injury that required partial thickness skin graft (meshed or sheet) for any location other than the face and genitalia
Skin graft size is between 50 cm2 and 800 cm2 (post-meshing, if a meshed graft)
If skin graft is meshed, maximum skin graft expansion ratio is 1:1.5
Able to apply the IPs as instructed, whether by the participants themselves or their accompanying caregivers

Exclusion Criteria:

Medically unable to consent to study requirements
Treatment site(s) (skin graft site) located on the face and genitalia
Treatment site(s) (skin graft site and skin donor site) that has not reached complete re-epithelization at baseline, based on the investigator's assessment
Expected to be medically unstable for the duration of the study period and an additional 1-month thereafter
Pregnant, or attempting to become pregnant
Subjects who had taken part in an interventional 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 within the last year
Subjects who smoke more than 20 cigarettes a day
Subjects who have a history of heavy drinking in the past month, defined as more than 14 drinks per week for men or more than 7 drinks per week for women
Subjects who have a history of substance abuse within the 12 months prior to screening (including having been hospitalized for such in an in-patient or out-patient intervention)
Subjects with severe inhalation injury requiring FiO2 >50%, renal failure requiring dialysis or hemodynamic instability requiring vasopressor therapy at the time of initiation of study treatment
Subjects who have scarring from previous interventions or evidence of thermal, electrical or radiation burn scars, tattoos, birthmarks or moles within 5 cm of the treatment sites
Subjects with a history of abnormal keloid scarring
Subjects with additional concurrent illnesses or conditions that may have interfered with wound healing like neoplastic, immune-mediated, or primary infectious disease (e.g. carcinoma, vasculitis, connective tissue disease, immune system disorders, uncontrolled HIV infection, rheumatoid arthritis, chronic renal impairment, significant hepatic impairment, inadequately or uncontrolled congestive heart failure or diabetes mellitus) or any clinically significant medical condition or history of any condition which may impair wound healing
Subjects with a skin disorder that is chronic or currently active and which the investigator considers will adversely affect the healing of acute wounds or will involve the areas to be examined in this trial (including psoriasis, dermatitis, eczema)
A history of radiotherapy to the study scar area
Subjects who have known sensitivity to any components of the IPs
Any other diagnosis, condition, physical or geographical limitation with the participant

Name	Role	Phone	Extension	Email
Adam Kuttenkeuler	Contact	+1519-341-3367	113	akuttenkeuler@nutrasource.ca
Stephanie Recker	Contact	1-887-557-7722		srecker@nutrasource.ca

ID	Term
D002056	Burns
D002921	Cicatrix

ID	Term
D014947	Wounds and Injuries
D005355	Fibrosis
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D017346	Protein Serine-Threonine Kinases
D011494	Protein Kinases
D017853	Phosphotransferases (Alcohol Group Acceptor)
D010770	Phosphotransferases