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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 3 July 2012
Main ID:  EUCTR2007-001810-18-GB
Date of registration: 10/07/2007
Primary sponsor: University Hospital Of North Staffordshire
Public title: Treatment of gastrostomy related granuloma using hydrocortisone or tea tree oil: A randomized controlled trial. - Hydrocortisone versus Tea Tree oil in treating gastrostomy related granuloma
Scientific title: Treatment of gastrostomy related granuloma using hydrocortisone or tea tree oil: A randomized controlled trial. - Hydrocortisone versus Tea Tree oil in treating gastrostomy related granuloma
Date of first enrolment: 06/09/2007
Target sample size: 0
Recruitment status: Authorised-recruitment may be ongoing or finished
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-001810-18
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: no
 
Countries of recruitment
United Kingdom
Contacts
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Key inclusion & exclusion criteria
Inclusion criteria:
• 0-18 years with symptomatic PEG site granulomas (Symptoms include: erythema, discharge, pain and/or pruritis)
• Informed written consent obtained from parents or carers with parental responsibility.
• Negative patch test to TTO(Tea Tree OIL)

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
• Allergy to TTO ( positive patch test to TTO)
• Cellulitis present at site of gastrostomy
• Previously recruited to the trial



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Granulomas related to gastrostomy sites in children
Intervention(s)

Product Name: Tea Tree oil Cream
Pharmaceutical Form: Cream

Product Name: Efcortelan cream 1%
Pharmaceutical Form: Cream

Primary Outcome(s)
Main Objective: Which type of topical treatment (tea tree oil or hydrocortisone) results in quicker disappearance of granulomas complicating Percutaneous Endoscopic Gastrostomy (PEG) insertion in children?

Primary end point(s): Weekly follow-up and measurement of granuloma size till complete disappearance or a maximum of 4 weeks when treatment would be considered to have failed.
Secondary Objective: • Change in granuloma size over the 4 weeks
• Percentage granuloma-free at 4 weeks
• Recurrence within 3 months
• Duration from disappearance to recurrence
• Secondary infection at site of granuloma
Secondary Outcome(s)
Secondary ID(s)
1503
Source(s) of Monetary Support
Secondary Sponsor(s)
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