Condition category
Surgery
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
23/04/2015
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

Mr Eoin O'Broin

ORCID ID

Contact details

c/o Research and Development Office
Leicester General Hospital NHS Trust
Leicester
LE1 4PW
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0123165848

Study information

Scientific title

A prospective controlled trial comparing silicone and PVC closed system wound drains

Acronym

Study hypothesis

To ascertain if there are differences in comfort levels for patients between two generic wound drain types. One type being the cheaper more conventional but stiffer plastic drain and the second a newer softer silicone drain.

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

Surgery

Intervention

Conventional stiffer plastic drain vs newer softer silicone drain

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

10/01/2005

Overall trial end date

30/04/2005

Reason abandoned

Eligibility

Participant inclusion criteria

All patients having a breast reduction, breast reconstruction or an abdominoplasty procedure under the care of Mr O'Broin.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

10/01/2005

Recruitment end date

30/04/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Leicester General Hospital NHS Trust
Leicester
LE1 4PW
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2006 Update - Department of Health

Sponsor details

The Department of Health
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

University Hospitals of Leicester NHS Trust (UK), Departmental Research Fund

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