Prevention of wound infection in pull-through percutaneous endoscopic gastrostomy
| ISRCTN | ISRCTN02507711 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN02507711 |
| Protocol serial number | N0025168201 |
| Sponsor | Record Provided by the NHSTCT Register - 2006 Update - Department of Health |
| Funders | Aintree Hospitals NHS Trust (UK), NHS R&D Support Funding |
- Submission date
- 29/09/2006
- Registration date
- 29/09/2006
- Last edited
- 15/03/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
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
Dr Suhail Ahmed
Scientific
Scientific
Gastroenterology
University Hospital Aintree
Longmoor Lane
Liverpool
L9 7AL
United Kingdom
| Phone | +44 0151 529 5089 |
|---|---|
| zebi14@hotmail.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Prospective randomised double-blind trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | PEG Study: Prevention of wound infection in pull-through percutaneous endoscopic gastrostomy (prospective randomised double-blind trial of novel technique) |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/09/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 60 |
| Key inclusion criteria | Not provided at time of registration |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/09/2005 |
| Date of final enrolment | 01/09/2007 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Gastroenterology
Liverpool
L9 7AL
United Kingdom
L9 7AL
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
15/03/2017: No publications found in PubMed, verifying study status with principal investigator
