Condition category
Injury, Occupational Diseases, Poisoning
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
06/11/2014
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

Mrs Judith McGovern

ORCID ID

Contact details

Department of Gastroenterology
Norfolk and Norwich University Hospital NHS Trust
Colney
Norwich
NR4 7UY
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0547127258

Study information

Scientific title

Acronym

Study hypothesis

Does the treatment, nasal mupirocin, have an effect on peristomal infection rate following percutaneous endoscopic gastrostomy (PEG) placement?

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

Post-percutaneous endoscopic gastrostomy sepsis

Intervention

Nasal mupirocin versus standard care (no prophylactic antibiotics).

Mupirocin was administered for 5 days before PEG insertion. Nasopharyngeal swabs, PEG site appearance and bacteriology were recorded up to 10 days post-PEG.

Intervention type

Drug

Phase

Not Applicable

Drug names

Mupirocin

Primary outcome measures

Pilot:
Will access the practicalities of the study design, the consistency of the scoring tool and also give an indication of the bacteriology of nasal colonisation, peristomal colonisation and infection within the proposed research setting.

Main:
The primary outcome measure is that of perstomal infection.

Secondary outcome measures

Secondary outcomes of peristomal colonisation and risk factors for methicillin resistant staphylococcus aureus (MRSA) colonisation will also be measured.

Overall trial start date

01/06/2003

Overall trial end date

01/12/2003

Reason abandoned

Eligibility

Participant inclusion criteria

Pilot study of 20 patients recruited, pilot study of 10 controls

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

30

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/06/2003

Recruitment end date

01/12/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Gastroenterology
Norwich
NR4 7UY
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

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

Funders

Funder type

Government

Funder name

East Norfolk and Waveney Research Consortium (UK) - Norfolk and Norwich University Hospital/Norwich PCT

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