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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
39
Fitzwilliam Clinic
Belfast, United Kingdom
Selly Oak Hospital
Birmingham, United Kingdom
Queen Victoria Hospital
East Grinstead, United Kingdom
Royal Victoria Infirmary
Newcastle upon Tyne, United Kingdom
Royal Preston Hospital
Preston, United Kingdom
Odstock Centre for Burns & Plastic Surgery, Salisbury District Hospital
Salisbury, United Kingdom
Investigator scar assessment
Patient scar assessment
Independent scar assessment
Local tolerance
Adverse events
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