Condition category
Surgery
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
19/05/2014
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 Suhail Ahmed

ORCID ID

Contact details

Gastroenterology
University Hospital Aintree
Longmoor Lane
Liverpool
L9 7AL
United Kingdom
+44 0151 529 5089
zebi14@hotmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0025168201

Study information

Scientific title

Acronym

Study hypothesis

The primary aim of the study is to investigate the utility of a polyurethane sheath used during PEG placements in preventing PEG site wound infection.

Ethics approval

Not provided at time of registration

Study design

Prospective randomised double-blind trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Surgery: Gastrostomy

Intervention

Throat swabs taken at pre-PEG assessment visit; consent; patients carers advised and explained to; demographics taken; examination of the oropharynx prior to PEG insertion; routine antibiotics as per protocol.
Randomisation into 2 groups, group one will undergo standard PEG, group two will undergo PEG insertion modified by use of protective sheath; patient review on the ward at 3/7 and 14 days and wound site assessed. At sign of infection swabs taken; a cohort of patients undergoing direct puncture PEG for pre-operative orophangeal cancer will be monitored; throat swabs taken and PEG wounds assessed/scored in same way as Group 1/2.

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

01/09/2005

Overall trial end date

01/09/2007

Reason abandoned

Eligibility

Participant inclusion criteria

60 patients total, 30 in control group.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

60

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/09/2005

Recruitment end date

01/09/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Gastroenterology
Liverpool
L9 7AL
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

Aintree Hospitals NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NHS R&D Support Funding

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