A randomised prospective comparison of tissue adhesive (Dermabond) versus standard wound closure in elective paediatric orthopaedic surgery

ISRCTN	ISRCTN35834020
DOI	https://doi.org/10.1186/ISRCTN35834020
Secondary identifying numbers	N0188149758

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 P Patil
Scientific

Orthopaedics Directorate
Chorley
PR7 1PP
United Kingdom

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title
Study objectives	To compare tissue adhesive (Dermabond) to subcuticular suture for the skin closure in paediatric elective orthopaedic study.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/01/2004
Completion date	01/08/2006

Participant type(s)	Patient
Age group	Child
Lower age limit	1 Year
Upper age limit	16 Years
Sex	Both
Target number of participants	50
Key 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
Key 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
Date of first enrolment	01/01/2004
Date of final enrolment	01/08/2006

Orthopaedics Directorate

Chorley
PR7 1PP
United Kingdom

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Government

Lancashire Teaching Hospitals NHS Trust (UK)

No information available

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