An investigation of the efficacy of a single dose of insulin in the prevention of excessive cutaneous scarring in breast surgery patients - Insulin as anti-scarring agent - breast surgery group

Pharmecosse0 个研究点目标入组 75 人开始时间: 2010年10月4日最近更新: 2019年6月30日

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•Patients undergoing 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 tendancy towards formation of excessive 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

•-Patients who have a history (either individual or familial)of keloid scarring. 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.
•-Younger than 18 or older than 60 (The rate of wound healing changes in these two age groups).
•-Smokers - impairs wound healing.
•-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.
•The first three exclusion criteria 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 breast reduction surgery.

发起方

Pharmecosse