Efficacy of topical diclofenac compared with bupivicaine in autologous split skin graft donor sites

ISRCTN	ISRCTN76218841
DOI	https://doi.org/10.1186/ISRCTN76218841
Protocol serial number	N0190083585
Sponsor	Department of Health
Funder	Queen Victoria Hospital NHS Trust (UK)

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

Dr PJH Venn
Scientific

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

Phone	+44 (0)1342 414000

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Is topical diclofenac more effective than bupivicaine in the treatment of post-operative wound pain at donor site
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Post operative pain
Intervention	Randomised, controlled preliminary study. Patients will act as own control as two separate donor strips will be harvested from different dermatomal distribution.
Intervention type	Other
Primary outcome measure(s)	Pain at donor site will be assessed using a visual analogue (VA) scale at 1, 2, 6, 8, 24, 48 and 72 hours post-operatively. Degree of healing will be assessed at dressing changes.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	30/03/2005

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Key inclusion criteria	Patients over 18 years requiring a split autograft under general anaesthetic
Key exclusion criteria	Does not match inclusion criteria
Date of first enrolment	30/03/2004
Date of final enrolment	30/03/2005

The Queen Victoria Hospital NHS Trust

East Grinstead
RH19 3DZ
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan