Scarring in non-cancer bilateral breast surgery Surgery Non-cancer bilateral breast surgery
Conditions
Interventions
Administration by local injection of placebo (vehicle only) along the edge of a 3 cm length of one wound and 0.4 IU insulin to the other wound (randomised and double blinded) during surgery. Total dur
Sponsors
Pharmecosse Ltd (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Severity of scar formation, as measured by standardised and accepted methods of scar tissue grading such as the Manchester Scar Scale, image analysis of digital photographs, and volumetric measurement of scar prominence using silicone moulds taken of the scars. Measured at 1 - 2 weeks and 3, 6 and 12 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Hypertrophic scars, measured at 1 - 2 weeks and 3, 6 and 12 months. | — |
Countries
United Kingdom
Outcome results
None listed