Exploring alternative wound care treatment for percutaneous gastrostomy site infection: A prospective, randomized, open, blinded end-point (PROBE) design.
Completed
- Conditions
- PEG-site infectionsInfectie van de PEG-insteekopening
- Registration Number
- NL-OMON23605
- Lead Sponsor
- VU Medical Center, Amsterdam
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
Inclusion Criteria
1. Signed informed consent;
2. PEG-site infection graded as type 1 & 2 (1= early signs of inflammation,proactive measures, 2= Requiring local antiseptic/antibiotic care);
Exclusion Criteria
1. Estimated life expectancy less than one month;
2. Concurrent use of oral antibiotics for other diagnosis;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome will be the reduction or increase in peristomal sepsis scoring in both groups using the scoring scale of Jain et al.
- Secondary Outcome Measures
Name Time Method 1. The number of patients in which the PEG - site infection was regarded as healed;<br /><br>2. Percentage decrease in number of bacterial species as measured by the IS-pro;<br /><br>3. Treatment related adverse events;<br /><br>4. Recurrence of infection 1 week after healing;<br /><br>5. Deterioration of the infection-site that will require withdrawal.