Intron A for the Treatment of Hypertrophic Scar
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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||A Double-blind Placebo Controlled Trial Using Subcutaneous Injections of Intron A for the Treatment of Hypertrophic Scar|
- Time [ Time Frame: 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||June 2012|
|Estimated Study Completion Date:||June 2015|
|Estimated Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
Drug: interferon alpha 2b
subcutaneous injection of 1 million units of interferon alpha 2b, 3 times per week for 6 months
Other Name: intron a
Placebo Comparator: 2
The objective of this trial is to analyze the systemic effects in the blood, urine and scar tissue in post-burn patients being treated with Intron A to determine the potential systemic and local factors that might contribute to the development and subsequent resolution of HTS following burn injury.
Primary Objective This is an observational trial to monitor the systemic (blood and urine) and local (tissue) effects of systemically administered Intron A in patients with post-burn HTS.
Patients and Methods
Study Design This is an ongoing observational trial in all patients being treated with Intron A for the treatment of severe HTS post burn injury. Following discussion, patients who agree to participate in the trial will have blood, urine and tissue (excised scars) collected.
Data Collection Demographic data age gender ethnicity
Injury data date etiology TBSA
Intron A standard assessments scar assessments psychological assessment and monitoring standardized non-identifying photographs blood and urine results
Subject Selection Inclusion Criteria Patients who are 18 - 65 years of age, male or female who are able to provide written or verbal informed consent who are being treated for severe HTS with Intron A will be asked to participate in the trial.
Exclusion Criteria Patients who following discussion do not wish to participate in the trial will be excluded from the trial.
Study Procedures Patients enrolled in the trial will have in-depth data collection of scar monitoring assessments and photographs as well as 60 cc of urine and 30 cc of blood collected at the same time as standard of care blood work (every 4 weeks) while being treated with Intron A.
Data collection be done while the patient is being treated with Intron A. As well, in the event the patient requires surgical intervention (ie scar excision) all tissue normally discarded will be collected and sent to the Plastic Surgery Research Laboratory for histological examination (ie HTS, mature scar, excess split or full thickness skin grafts, heterotopic bone).
Informed Consent Each prospective subject must be informed of the purpose and the nature of the study, its possible hazards, and his/her right to withdraw from the study at any time without prejudice to future treatment. Informed consent must be obtained from a subject before any assessments or study-related procedures are performed. The subject's medical record will clearly indicate the subject is participating in the trial. The informed consent will be supplied in three copies, with the original copy kept within the subject case report form, a copy provided to the subject, and a copy in the subject's source documents.
|Contact: Heather Shankowsky, RN CCRP||780-407-3408|
|University of Alberta|
|Edmonton, Alberta, Canada, T6G 2B7|
|Principal Investigator:||Edward E Tredget, MD MSc FRCSC||University of Alberta|