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 |
| Secondary identifying numbers | N0013146160 |
- 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
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 |
|---|---|
| mark.mcgurk@kcl.ac.uk |
Study information
| Study design | Randomised open label controlled parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient 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 | 1. Rate of healing of the skin grafts 2. Reduction of skin graft failures |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 02/01/2004 |
| Completion date | 02/01/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | Not provided at time of registration |
| 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
- England
- United Kingdom
Study participating centre
Guy's Hospital
London
SE1 9RT
United Kingdom
SE1 9RT
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
Guy's and St. Thomas' NHS Foundation Trust (UK)
No information available
Own account
No information available
NHS R&D Support Funding
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
12/02/2018: No publications found, verifying study status with principal investigator.
