The effect of nasal mupirocin, prior to percutaneous endoscopic gastrostomy (PEG), upon peristomal colonisation and infection

ISRCTN ISRCTN46568273
DOI https://doi.org/10.1186/ISRCTN46568273
Secondary identifying numbers N0547127258
Submission date
30/09/2004
Registration date
30/09/2004
Last edited
06/11/2014
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Injury, Occupational Diseases, Poisoning
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

Contact information

Mrs Judith McGovern
Scientific

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

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectivesDoes the treatment, nasal mupirocin, have an effect on peristomal infection rate following percutaneous endoscopic gastrostomy (PEG) placement?
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedPost-percutaneous endoscopic gastrostomy sepsis
InterventionNasal 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Mupirocin
Primary outcome measurePilot:
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 measuresSecondary outcomes of peristomal colonisation and risk factors for methicillin resistant staphylococcus aureus (MRSA) colonisation will also be measured.
Overall study start date01/06/2003
Completion date01/12/2003

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants30
Key inclusion criteriaPilot study of 20 patients recruited, pilot study of 10 controls
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/06/2003
Date of final enrolment01/12/2003

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Department of Gastroenterology
Norwich
NR4 7UY
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

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

Funders

Funder type

Government

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan