Condition category
Surgery
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
07/04/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr P Patil

ORCID ID

Contact details

Orthopaedics Directorate
Chorley
PR7 1PP
United Kingdom

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

http://www.dh.gov.uk/Home/fs/en

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

Publication citations

Additional files

Editorial Notes