Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0190083585
Study information
Scientific title
Acronym
Study hypothesis
Is topical diclofenac more effective than bupivicaine in the treatment of post-operative wound pain at donor site
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measure
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.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
30/03/2004
Overall trial end date
30/03/2005
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients over 18 years requiring a split autograft under general anaesthetic
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Does not match inclusion criteria
Recruitment start date
30/03/2004
Recruitment end date
30/03/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
The Queen Victoria Hospital NHS Trust
East Grinstead
RH19 3DZ
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Queen Victoria Hospital NHS Trust (UK)
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
Basic results (scientific)
Publication list