An investigation of the efficacy of a single dose of insulin in the prevention of excessive cutaneous scarring in breast surgery patients

ISRCTN ISRCTN51295799
DOI https://doi.org/10.1186/ISRCTN51295799
Secondary identifying numbers 10-0001
Submission date
03/08/2010
Registration date
26/08/2010
Last edited
17/01/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Charles Nduka
Scientific

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

Study information

Study designRandomised controlled phase II clinical trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleAn 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
Study acronymIBBS
Study objectivesTreatment 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedScarring in non-cancer bilateral breast surgery
InterventionAdministration 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 typeDrug
Pharmaceutical study type(s)
PhasePhase II
Drug / device / biological / vaccine name(s)Insulin
Primary outcome measureSeverity 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 measuresHypertrophic scars, measured at 1 - 2 weeks and 3, 6 and 12 months.
Overall study start date31/10/2010
Completion date31/10/2012

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexFemale
Target number of participants75
Key inclusion criteria1. 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.
Key exclusion criteria1. 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.
Date of first enrolment31/10/2010
Date of final enrolment31/10/2012

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

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

Sponsor information

Pharmecosse Ltd (UK)
Industry

14 City Quay
Dundee
DD1 3JA
United Kingdom

Website http://www.pharmecosse.com/
ROR logo "ROR" https://ror.org/011nmry48

Funders

Funder type

Industry

Pharmecosse Ltd (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/04/2018 17/01/2019 Yes No

Editorial Notes

17/01/2019: Publication reference added
04/10/2017: No publications found in PubMed, verifying study status with principal investigator.