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 |
| Protocol serial number | 10-0001 |
| Sponsor | Pharmecosse Ltd (UK) |
| Funder | Pharmecosse Ltd (UK) |
- 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
Scientific
Queen Victoria Hospital NHS Foundation Trust
Holtye Road
E Grinstead
RH19 3DZ
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled phase II clinical trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| 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 |
| Study acronym | IBBS |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | Insulin |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
Hypertrophic scars, measured at 1 - 2 weeks and 3, 6 and 12 months. |
| Completion date | 31/10/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target sample size at registration | 75 |
| Key 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. |
| Key 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. |
| Date of first enrolment | 31/10/2010 |
| Date of final enrolment | 31/10/2012 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Queen Victoria Hospital NHS Foundation Trust
E Grinstead
RH19 3DZ
United Kingdom
RH19 3DZ
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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 |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
17/01/2019: Publication reference added
04/10/2017: No publications found in PubMed, verifying study status with principal investigator.
