Phase
Condition
Scar Tissue
Hyponatremia
Skin Wounds
Treatment
IP2 - 0.5% w/w FS2
IP1 control cream (Vehicle base)
Clinical Study ID
Ages 18-60 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Medically able and willing to consent to study requirements
Adult, male and female burn patients
Ages 18 to 60 years of age
Able to understand the study requirements and consent without a translator
Have a BMI between 15 and 35 kg/m2 (inclusive)
Have clinically acceptable results in the safety laboratory tests as deemed by theinvestigator
Have full thickness burn injury that requires partial thickness skin graft (meshed)for any location other than the face and genitalia
Meshed skin graft size is between 50 cm2 and 800 cm2
Maximum skin graft expansion ratio is 1:1.5
Able to apply the IPs as instructed, whether by the participants themselves or theiraccompanying caregivers
Exclusion
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) take more than 14 days after the skin graftsurgery to reach complete re-epithelization, based on the investigator's assessment
Expected to be medically unstable for the duration of the study period and anadditional 1-month thereafter
Pregnant, or attempting to become pregnant
Subjects who had taken part in an interventional clinical trial within 3 monthsprior to admission to this trial or who are currently participating in a clinicaltrial, whether an investigational drug was used or not
Subjects who had any clinical evidence of severe ongoing or prolonged depression ormental 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 morethan 14 drinks per week for men or more than 7 drinks per week for women
Subjects who have a history of substance abuse in the 12 months prior to screening (including having been hospitalized for such in an in-patient or out-patientintervention)
Subjects with severe inhalation injury requiring FiO2 >50%, renal failure requiringdialysis or hemodynamic instability requiring vasopressor therapy at the time ofinitiation 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 thetreatment sites
Subjects with a history of abnormal keloid scarring
Subjects with additional concurrent illnesses or conditions that may have interferedwith 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 heartfailure or diabetes mellitus) or any clinically significant medical condition orhistory of any condition which may impair wound healing
Subjects with a skin disorder that is chronic or currently active and which theinvestigator considers will adversely affect the healing of acute wounds or willinvolve 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 sensitivities to any components of the IPs
Any other diagnosis, condition, physical or geographical limitation with theparticipant
Study Design
Study Description
Connect with a study center
University of Alberta, Division of Plastic Surgery
Edmonton, Alberta T6G 2B7
CanadaSite Not Available
University of Alberta, Division of Plastic Surgery
Edmonton 5946768, Alberta 5883102 T6G 2B7
CanadaActive - Recruiting
Centre for Burn Research - Hamilton Health Sciences
Hamilton, Ontario L8L 2X2
CanadaSite Not Available
Centre for Burn Research - Hamilton Health Sciences
Hamilton 5969782, Ontario 6093943 L8L 2X2
CanadaActive - Recruiting

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