Scar study
| ISRCTN | ISRCTN27023864 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN27023864 |
| Protocol serial number | V0.6 |
| Sponsor | Queen Victoria Hospital NHS Foundation Trust |
| Funders | Queen Victoria Hospital NHS Foundation Trust, Blond McIndoe Research Foundation |
- Submission date
- 22/09/2016
- Registration date
- 20/10/2016
- Last edited
- 01/12/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Skin and Connective Tissue Diseases
Plain English summary of protocol
Background and study aims
Scars are areas of fibrous (made up of fibres) tissue that replace normal skin after injury. A scar is a natural result of the healing process, and comes from the biological process of wound repair in the skin and other tissues of the body. With the exception of very minor lesions (cuts), every wound (e.g. after accident, disease, or surgery) results in some degree of scarring. There is a lack of a clear understanding of the processes involved in fibrosis (the thickening of connective tissue) and scar formation and research directed towards technologies that can lead to scar reduction are lacking.
The Queen Victoria Hospital (QVH) is a regional centre for burns and plastic surgery. The hospital treats patients with acute (sudden) wounds and those undergoing surgical reconstruction and scar revision. As part of this treatment scar tissue will often be removed and disposed of as clinical waste. The aim of this study is to look at these discarded scars in order to investigate how the different molecules affect the development of human scars.
Who can participate?
Adults who are going to have a scar surgically removed or released (releasing a tight scar to improve movement)
What does the study involve?
Potential participants are approached by the research team after a consultant plastic surgeon has planned their scar revision surgery. An information sheet and explanation about the study is given by a member of the research team so that the participant can decide if they want to take part. Two weeks before surgery, a researcher contacts the potential participant and gains consent. The participant has surgery as planned and the tissue that is removed is collected. The participant also gives a blood sample and additional consent for a punch biopsy (having a small sample taken with a circular blade) to be taken from an area of normal skin next to the scar. Before undergoing surgery, participants also complete a questionnaire about how they got the scar in the first place.
What are the possible benefits and risks of participating?
There are no direct benefits or risks involved with participating in this study.
Where is the study run from?
Queen Victoria Hospital (UK)
When is the study starting and how long is it expected to run for?
March 2016 to January 2026
Who is funding the study?
Queen Victoria Hospital NHS Foundation Trust (UK)
Who is the main contact?
Mr Simon Booth
simon.booth@nhs.net
Contact information
Public
Queen Victoria Hospital NHS Foundation Trust
Holtye Rad
East Grinstead
RH19 3DZ
United Kingdom
 ORCID ID |
0000-0003-2398-7103 |
|---|---|
| Phone | +44 (0)1342 414000 |
| simon.booth@nhs.net |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Observational cross sectional study |
| Secondary study design | Cross sectional study |
| Study type | Participant information sheet |
| Scientific title | What is the pattern and interrelationship between the biomarkers of scarring and fibrosis and the observed phenotypic scarring severity |
| Study objectives | The aim of this study is to investigate the pattern and interrelationship between the biomarkers of scarring and fibrosis and the observed phenotypic scarring severity. |
| Ethics approval(s) | South East Coast - Brighton & Sussex Research Ethics Committee, 15/03/2016, ref: 16/LO/0372 |
| Health condition(s) or problem(s) studied | Cutaneous scarring |
| Intervention | Potential participants will be approached by the research team after a consultant plastic surgeon has planned scar revision surgery. An information sheet and explanation about the study will be given by a member of the research team. Two weeks before surgery, a researcher will contact the potential participant and gain consent. Prior to surgery participants will complete a short scar assessment questionnaire, which investigates the origin of the scar as well as patient demographics and scar assessment by an experienced clinician. After the scar tissue is excised during surgery, the sample will be transferred to the research laboratory, cut into sections and examined using histological and immunological stains. The patient will not receive any follow up outside of standard care. |
| Intervention type | Mixed |
| Primary outcome measure(s) |
Scar severity is measured using modified Vancouver scar scale, Patient and Observer scar scale and the Manchester scar scale before surgery. |
| Key secondary outcome measure(s) |
Expression of Biomarker level in scar sample biopsy is measured using semi quantitative immune-histochemistry and gross morphology of skin section using histological stains at the time of surgery. |
| Completion date | 01/01/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 300 |
| Key inclusion criteria | 1. Aged over 18 2. Patients with a scar suitable for surgical excision |
| Key exclusion criteria | Not meeting exclusion criteria |
| Date of first enrolment | 09/09/2016 |
| Date of final enrolment | 01/12/2021 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
East Grinstead
RH19 3DZ
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Simon.booth@qvh.nhs.uk |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
01/12/2020: The recruitment end date has been changed from 30/06/2020 to 01/12/2021.
30/11/2020: Blond McIndoe Research Foundation has been removed from the trial participating centres.
08/05/2020: The trial contact email has been updated and the plain English summary has been updated accordingly.
07/08/2018: The following changes were made to the trial record:
1. The recruitment end date was changed from 01/04/2018 to 30/06/2020.
2. The intention to publish date was changed from 30/06/2020 to 30/06/2026.
