Hypertrophic Scar Clinical Trial
Official title:
Role of Topical Putrescine (Fibrostat) in 10%Urea (TFU) for Prevention of Hypertrophic Scars in Mammoplasty Patients
Verified date | November 2017 |
Source | University of Manitoba |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Linked to previous Clinical Trial E92:069 in which biochemical effect of 1,4 diaminobutane was studied in human scar harvested at revision surgery after a 12 week application. Analytical data was collected in this phase of the work completed in 1999. This was then followed by clinical correlation in a scar prevention model with topical application of 1,4 diaminobutane for 12 weeks and measuring duredness , as well photographic and POSAS score data for quality of scar formation.
Status | Completed |
Enrollment | 56 |
Est. completion date | July 15, 2016 |
Est. primary completion date | August 13, 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: Undergoing breast reduction surgery - Exclusion Criteria: Not pregnant or lactating |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Manitoba |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Duredness of scar at post treatment time frame for active versus control breast | Surface deformational force in grams of scar tissue in each of the treated breasts | 12 weeks | |
Secondary | Patient Observer Objective Scar Assessment Scale ratings | Validated scale of scar outcome based on seven parameters graded on a scale of 1-10 ranked lowest to highest in severity. Patient was the "observer" in this study making subjective parameters listed such as pain and itch a direct patient correlate rather than one recorded by a second-person observation. | at least one year post operatively |
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