An investigation of the efficacy of a single dose of insulin in the prevention of excessive cutaneous scarring in breast surgery patients: a phase II randomised controlled clinical trial

Pharmecosse Ltd (UK)0 sites75 target enrollmentAugust 26, 2010

Overview

Registry

who.int

Start Date

August 26, 2010

End Date

October 31, 2012

Last Updated

7 years ago

Study Type

Interventional

Sex

Female

Sponsor

Pharmecosse Ltd (UK)

•1\. Female patients aged 18 \- 60 years
•2\. Undergoing non\-cancer related bilateral breast surgery \- this patient group has been chosen for two reasons: Firstly they have two identical wounds allowing an ideal intra\-patient placebo control since scarring severity varies markedly not only between individuals but also between body sites. Secondly these wounds have a high tendency towards formation of excessive scarring.

•1\. Patients with diagnosed breast cancer
•2\. Patients with a history (either individual or familial) of keloid scarring (suspected to have a genetic component). Keloid scars are the most severe and pernicious form of pathological scarring that unlike hypertrophic scarring appear to behave in an almost cancer\-like fashion invading the surrounding non\-wounded normal tissue. The causes of this form of scarring are likely to be more complex and potentially multi\-factorial. In addition this particular condition is thought to have a genetic link and might therefore introduce extra variables which might complicate correct analysis of results.
•3\. Younger than 18 or older than 60 (The rate of wound healing is known to be different within these two age groups)
•4\. Smokers \- impairs wound healing
•5\. Any systemic illness that could have a theoretical interaction with the insulin administered such as diabetics, patients with renal or liver disease or endocrine tumours
•Exclusion criteria 2 \- 4 are designed to eliminate extra variables which might complicate correct analysis of results. These criteria are largely theoretical as patients who do exhibit any of these features are unlikely to be put forward for non\-cancer related breast surgery.