An investigation into a novel clinical use of a single low dose of insulin in the prevention of excessive cutaneous scarring
Phase 1
- Conditions
- Normal scarring Hypertrophic scarring Hypertrophic scarring
- Registration Number
- EUCTR2005-001259-39-GB
- Lead Sponsor
- West Herts NHS Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 15
Inclusion Criteria
Heathly subjects having elective bilateral breast reduction surgery.
Ages 18 - 65.
Caucasian (to exclude racial differences in scarring).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Diabetes mellitus
Patients with a history of hypertrophic or keloid scarring
Smokers - impairs wound healing
Any systemic illness that could have a theoretical interaction with the insulin administered such as patients with renal or liver disease or endocrine tumours
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To determine whether local infiltration of insulin to a wound at the time of closure can reduce scarring severity.;Secondary Objective: ;Primary end point(s): A statistically proven reduction in postoperative cutaneous scarring.
- Secondary Outcome Measures
Name Time Method