Burn, Hypertrophic Scar
Conditions
Keywords
burn, hypertrophic scar, fibroproliferative disorder
Brief summary
This study assesses the intervention with antifibrotic agents, specifically interferon (IFN) to reduce the magnitude and duration of hypertrophic scar. Burn patients with hypertrophic scar are randomly assigned to either an intervention IFN group or a placebo control group by subcutaneous injection three times a week. Patients are assessed using cutometer, mexameter, standardized photography, urinalysis, blood work, tissue biopsies and the Vancouver Burn Scar Assessment (VBSA) which rates selected HTS based on color, vascularity, height, pliability, itchiness and pain sensitivity. Once on treatment patients are assessed monthly for the six month treatment period.
Detailed description
Burn patients being followed and treated in the Outpatient Burn Clinic with large areas of HTS are approached to participate in the study. Patients who agree to participate and who have signed an informed consent are entered into the trial. Pre-treatment evaluation and monthly examinations include: * standardized photographs of scar * scar volume * Vancouver Burn Scar Assessment (VBSA) * blood work (TGF-beta, histamine) * urine collection (histamine) * 6mm punch biopsy of HTS and adjacent normal skin (every two months) Patients are randomized to received with placebo or Intron A 1x106 IU a day for 7 days, then 3x106 IU 3 SC, three times a week for 23 weeks.
Interventions
1 million IU of interferon alpha 2b (Intron A) subcutaneously once a day for 7 days, then 3 million IU of interferon alpha 2b (Intron A) subcutaneously three times a week for 23 weeks.
Sponsors
University of Alberta
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* burns \> 5% tbsa * informed consent * no prior exposure to interferon or other cytokines
Exclusion criteria
* history of cardiac or CNS disorder or disease * autoimmune disease * immunodeficiency * abnormal renal or hepatic function * pregnancy * serious intercurrent illness * active infection * malnutrition * active drug or alcohol abuse
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Systemic effect of Intron A on hypertrophic scar | once / month for 6 months | standardized photographs of scar, scar volume, Vancouver Burn Scar Assessment (VBSA), blood work (TGF-beta, histamine), urine collection (histamine), biopsy of HTS and adjacent normal skin. |
Countries
Canada
Outcome results
None listed