Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Mark McGurk

ORCID ID

Contact details

Oral Surgery
23rd Floor
Guy's Tower
Guy's Hospital
St Thomas' Street
London
SE1 9RT
United Kingdom
+44 (0)20 7188 4349
mark.mcgurk@kcl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0013146160

Study information

Scientific title

Acronym

Study hypothesis

To see if a concentrated preparation of growth factors found in your blood cells speeds up the healing of a skin graft placed at the site a skin flap has been raised from your forearm.

Ethics approval

Not provided at time of registration

Study design

Randomised open label controlled parallel group 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

Head and neck cancers

Intervention

A Randomised Controlled Trial. New patients will be recruited from the head and neck clinic who present requiring surgical treatment of their oral cancer involving reconstruction with a skin only radial forearm flap. These patients will be randomised to a treatment group and a control group.
Treatment group PRP applied to donor site before skin graft is sutured using standard protocol.
Control group no PRP applied. It is not necessary to blind either the patients or the investigators to the treatment.
Follow-up standardised digital clinical photographs, from fixed distance with a grid, will be taken of the skin graft at 5 set post operative intervals. These will be evaluated by 2 independent clinicians blinded to the treatment groups. The primary end point is complete graft failure. The secondary end point is the degree of graft failure as a percentage of the whole flap. All patients will be monitored as per standard head and neck protocol until all wounds have healed.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Rate of healing of the skin grafts
2. Reduction of skin graft failures

Secondary outcome measures

Not provided at time of registration

Overall trial start date

02/01/2004

Overall trial end date

02/01/2006

Reason abandoned

Eligibility

Participant inclusion criteria

New patients attending the Head and Neck Oncology clinic at Guy's Hospital with a cancer requiring surgical excision and reconstruction with a skin only radial forearm flap will be identified and approached by an investigator who is a member of the clinical team. Those patients who chose to join the study will be randomised to the treatment and control groups.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

02/01/2004

Recruitment end date

02/01/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Oral Surgery
London
SE1 9RT
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2005 Update - Department of Health (UK)

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Guy's and St. Thomas' NHS Foundation Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Own account

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NHS R&D Support Funding

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

Editorial Notes