Finding a new treatment for infection of the skin surrounding the stomach feeding-tube.

• Conditions: Infection of the PEG(percutanous endoscopic gastrostomy)-insertion site.; MedDRA version: 13.1Level: LLTClassification code 10021802Term: Infection and inflammatory reaction due to unspecified device, implant, and graftSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2011-001251-37-NL
• Lead Sponsor: Vu Medical center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04-06
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

-Signed informed consent.
-PEG-site infection graded as type 1& 2
-Male and female participants age 18 and older
-PEG insertion procedure longer than 1 week prior to randomization
-Patient or guardian is able to fully comprehend and perform study procedures

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

-Estimated life expectancy less than one month
-Concurrent use of oral antibiotics for other diagnosis
-Signs and symptoms of concurrent disease for which the subject is expected to start antibiotic treatment
-PEG-site infection graded as type 3 & 4

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified