Study of the effect of platelet rich plasma (PRP) on the healing of skin grafts placed on radial forearm donor sites in patients being treated for head and neck cancer

ISRCTN	ISRCTN83184634
DOI	https://doi.org/10.1186/ISRCTN83184634
Protocol serial number	N0013146160
Sponsor	Department of Health
Funders	Guy's and St. Thomas' NHS Foundation Trust (UK), Own account, NHS R&D Support Funding

Submission date: 30/09/2005
Registration date: 30/09/2005
Last edited: 12/02/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Mark McGurk
Scientific

Oral Surgery
23rd Floor
Guy's Tower
Guy's Hospital
St Thomas' Street
London
SE1 9RT
United Kingdom

Phone	+44 (0)20 7188 4349
Email	mark.mcgurk@kcl.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised open label controlled parallel group trial
Secondary study design	Randomised parallel trial
Study type	Participant information sheet
Scientific title	Study of the effect of platelet rich plasma (PRP) on the healing of skin grafts placed on radial forearm donor sites in patients being treated for head and neck cancer
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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	Procedure/Surgery
Primary outcome measure(s)	1. Rate of healing of the skin grafts 2. Reduction of skin graft failures
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	02/01/2006

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Key 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
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	02/01/2004
Date of final enrolment	02/01/2006

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Guy's Hospital

London
SE1 9RT
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?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

12/02/2018: No publications found, verifying study status with principal investigator.