Cicatrix Clinical Trial
Official title:
A Double Blind, Placebo Controlled, Randomised Trial to Investigate the Efficacy of Juvista (Avotermin) in the Improvement of Scar Appearance in Patients Undergoing Bilateral Reduction Mammaplasty.
Severe scarring is a common problem following breast reduction surgery, studies have shown
that over 64% of patients develop a hypertrophic scar at three months after the operation.
Scar severity can be influenced by a large number of factors including age, sex, skin
thickness and tension, ethnicity and the position of the scar on the body. Therefore the
most sensitive and reliable method to assess the efficacy of an anti-scarring treatment is
to compare bilateral wounds on the same individual. Bilateral breast reduction surgery
provides an ideal model for a within patient evaluation of anti-scarring activity in wounds
which develop into bad scars.
This study is being undertaken to investigate the efficacy and safety of Juvista (given as
an intradermal injection of 200ng per 1cm wound margin) in the reduction of scar appearance
applied to approximated wound margins following bilateral reduction mammaplasty.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Prevention
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