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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-001810-18-GB

Enrollment

Registered

2007-07-10

Start date

2007-09-06

Completion date

Unknown

Last updated

2019-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Granulomas related to gastrostomy sites in children

Interventions

Product Name: Tea Tree oil Cream Pharmaceutical Form: Cream Product Name: Efcortelan cream 1% Pharmaceutical Form: Cream

Eligibility

Sex/Gender

All

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
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? ; 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 ;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.	—

Measure

Time frame

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? ; 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 ;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.

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026