Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
10-0001
Study information
Scientific title
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
Acronym
IBBS
Study hypothesis
Treatment of non-cancer bilateral breast surgery wounds with a single low-dose application of insulin will improve the appearance of scarring as compared to that seen under standard care.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled phase II clinical trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Scarring in non-cancer bilateral breast surgery
Intervention
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 duration of follow-up per patient is 12 months.
Intervention type
Drug
Phase
Phase II
Drug names
Insulin
Primary outcome measures
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 outcome measures
Hypertrophic scars, measured at 1 - 2 weeks and 3, 6 and 12 months.
Overall trial start date
31/10/2010
Overall trial end date
31/10/2012
Reason abandoned
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
75
Participant 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.
Recruitment start date
31/10/2010
Recruitment end date
31/10/2012
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Queen Victoria Hospital NHS Foundation Trust
E Grinstead
RH19 3DZ
United Kingdom
Sponsor information
Organisation
Pharmecosse Ltd (UK)
Sponsor details
14 City Quay
Dundee
DD1 3JA
United Kingdom
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Pharmecosse Ltd (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary