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
Scientific
Department of Gastroenterology
Norfolk and Norwich University Hospital NHS Trust
Colney
Norwich
NR4 7UY
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | Does 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) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Mupirocin |
| Primary outcome measure | 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 study start date | 01/06/2003 |
| Completion date | 01/12/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 30 |
| Key inclusion criteria | Pilot study of 20 patients recruited, pilot study of 10 controls |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/06/2003 |
| Date of final enrolment | 01/12/2003 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Gastroenterology
Norwich
NR4 7UY
United Kingdom
NR4 7UY
United Kingdom
Sponsor information
Department of Health
Government
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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
