Prevention of wound infection in pull-through percutaneous endoscopic gastrostomy

ISRCTN	ISRCTN02507711
DOI	https://doi.org/10.1186/ISRCTN02507711
Secondary identifying numbers	N0025168201

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

Dr Suhail Ahmed
Scientific

Gastroenterology
University Hospital Aintree
Longmoor Lane
Liverpool
L9 7AL
United Kingdom

Phone	+44 0151 529 5089
Email	zebi14@hotmail.com

Study design	Prospective randomised double-blind trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
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	Not provided at time of registration
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/09/2005
Completion date	01/09/2007

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	60 patients total, 30 in control group.
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

Gastroenterology

Liverpool
L9 7AL
United Kingdom

Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government

The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom

Government

Aintree Hospitals NHS Trust (UK)

No information available

NHS R&D Support Funding

No information available

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

15/03/2017: No publications found in PubMed, verifying study status with principal investigator