Condition category
Surgery
Date applied
03/08/2010
Date assigned
26/08/2010
Last edited
11/06/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Charles Nduka

ORCID ID

Contact details

Queen Victoria Hospital NHS Foundation Trust
Holtye Road
E Grinstead
RH19 3DZ
United Kingdom

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

http://www.pharmecosse.com/

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

Publication citations

Additional files

Editorial Notes