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
Phase 1
- Conditions
- Granulomas related to gastrostomy sites in children
- Registration Number
- EUCTR2007-001810-18-GB
- Lead Sponsor
- niversity Hospital Of North Staffordshire
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method