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The purpose of this study is to investigate the accelerated-healing potential of injection or injection plus topical application of Juvista to minor split skin grafts (SSG).
Subjects were allocated into three groups (Group 1, Group 2 and Group 3) with all subjects receiving two 3cm2 SSG donor sites, one to each side of the lower back. Before wounding on Day 0, each site was randomised to receive either an intradermal injection of Juvista (50ng/100μl/cm2), an intradermal injection of Placebo (100μl/cm2) or no injection (Standard Care). After wounding, subjects allocated to Group 2 and Group 3 also received topical Juvista (100ng/200μl/cm2), topical Placebo (200μl/cm2) or Standard Care (Tegaderm dressing only). Topical Juvista and Placebo were held within a Granuflex ring dressing and sealed with a sterile Tegaderm dressing.
On Day 1, subjects in Group 2 and Group 3 received a further topical application of Juvista, Placebo or Standard Care according to the same treatment randomisation as Day 0.
Punch biopsy samples of healing SSG donor sites were harvested from Group 3 subjects on Day 3, 5, 7 or 10, and preserved for histological analysis.
The final study visit for Group 3 subjects was the day of the biopsy visit. Subjects in Group 1 and Group 2 underwent scar assessments at the first follow-up at Month 1 and at Months 2, 3, 4, 5, 6, 9 and 12.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Avotermin, Placebo, Avotermin, Placebo
Published on BioPortfolio: 2014-08-27T03:19:04-0400
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