Exploring alternative wound care treatment for percutanous gastrostomy site infection: a prospective, randomized, open, blinded end-point (PROBE) design.
Completed
- Conditions
- 10014982stomal infection/ tube infection
- Registration Number
- NL-OMON36555
- Lead Sponsor
- Vrije Universiteit Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
Inclusion Criteria
Signed informed consent
PEG-site infection graded as type 1 (early signs of inflammation<=proactive measures)
& type 2 (requiring local antiseptic/antibiotic care)
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
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 (requiring systemic antibiotics )
& 4 (requiring surgery or PEG-tube removal)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint will be the reduction or increase in peristomal sepsis<br /><br>scoring in both groups as evaluated by the blinded assessor using the validated<br /><br>scoring scale of Jain et al. </p><br>
- Secondary Outcome Measures
Name Time Method <p>* The number of patients in which the PEG site infection was regarded as healed<br /><br>after two weeks of treatment. Healing is defined as no sign and symptoms of<br /><br>infection such as erythema, induration , purulent discharge and skin closure<br /><br>as confirmed by the blinded assessor.<br /><br>* Percentage decrease in number of bacterial species as measured by the IS-pro<br /><br>method.<br /><br><br /><br>* Treatment related adverse events<br /><br><br /><br>* Recurrence of infection 1 week after healing<br /><br><br /><br>* Deterioration of the infection-site that will require withdrawal </p><br>