Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0188149758
Study information
Scientific title
Acronym
Study hypothesis
To compare tissue adhesive (Dermabond) to subcuticular suture for the skin closure in paediatric elective orthopaedic study.
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
Wound closure in orthopaedic surgery
Intervention
A prospective randomised controlled pilot study. Patients will be randomised to:
1. Tissue adhesive (Dermabond)
2. Standard wound closure
Intervention type
Procedure/Surgery
Phase
Not Specified
Drug names
Primary outcome measures
1. Time for closure of wound
2. Early and late complications
3. Patients and physician's assessment of cosmetic appearance of the healed wound
4. Cost effectiveness
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/2004
Overall trial end date
01/08/2006
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients who are more than 1 year old and less than 16
2. Undergoing elective orthopaedic procedures
3. In good health and without significant abnormalities
4. Agreeing to return for follow-up at 10 days, 6 weeks and 6 months
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
50
Participant exclusion criteria
1. Known bleeding diathesis
2. Insulin dependent diabetes mellitus
3. Known personal or family history of keloid formation or scar hypertrophy
4. Known allergy to cyanoacrylate compounds or formaldehyde
Recruitment start date
01/01/2004
Recruitment end date
01/08/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Orthopaedics Directorate
Chorley
PR7 1PP
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Lancashire Teaching Hospitals 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
Results - basic reporting
Publication summary