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
Protocol serial number	N0188149758
Sponsor	Department of Health
Funder	Lancashire Teaching Hospitals 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 P Patil
Scientific

Orthopaedics Directorate
Chorley
PR7 1PP
United Kingdom

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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(s)	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
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/08/2006

Participant type(s)	Patient
Age group	Child
Lower age limit	1 Year
Upper age limit	16 Years
Sex	All
Target sample size at registration	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

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