Condition category
Skin and Connective Tissue Diseases
Date applied
22/09/2016
Date assigned
20/10/2016
Last edited
20/10/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

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?
1. Queen Victoria Hospital NHS Foundation Trust (UK)
2. Blond McIndoe Research Foundation (UK)

Who is the main contact?
Mr Simon Booth
simon.booth@qvh.nhs.uk

Trial website

Contact information

Type

Public

Primary contact

Mr Simon Booth

ORCID ID

http://orcid.org/0000-0003-2398-7103

Contact details

Queen Victoria Hospital NHS Foundation Trust
Holtye Rad
East Grinstead
RH19 3DZ
United Kingdom
+44 1342 414000
simon.booth@qvh.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

V0.6

Study information

Scientific title

What is the pattern and interrelationship between the biomarkers of scarring and fibrosis and the observed phenotypic scarring severity

Acronym

Study hypothesis

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

South East Coast - Brighton & Sussex Research Ethics Committee, 15/03/2016, ref: 16/LO/0372

Study design

Observational cross sectional study

Primary study design

Observational

Secondary study design

Cross sectional study

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Drug names

Primary outcome measure

Scar severity is measured using modified Vancouver scar scale, Patient and Observer scar scale and the Manchester scar scale before surgery.

Secondary outcome measures

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.

Overall trial start date

01/03/2016

Overall trial end date

01/01/2026

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Aged over 18
2. Patients with a scar suitable for surgical excision

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned number of participants = 300

Participant exclusion criteria

Not meeting exclusion criteria

Recruitment start date

09/09/2016

Recruitment end date

01/04/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Queen Victoria Hospital
Holtye Road
East Grinstead
RH19 3DZ
United Kingdom

Trial participating centre

Blond McIndoe Research Foundation
Holtye Road E Grinstead W Sussex RH19 3DZ
E Grinstead
RH19 3DZ
United Kingdom

Sponsor information

Organisation

Queen Victoria Hospital NHS Foundation Trust

Sponsor details

Holtye Road
East Grinstead
RH19 3DZ
United Kingdom
+44 1342 414573
sarah.dawe@qvh.nhs.uk

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Queen Victoria Hospital NHS Foundation Trust

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Blond McIndoe Research Foundation

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal 2020 onwards.

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

Intention to publish date

30/06/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes