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Exploring alternative wound care treatment for percutaneous gastrostomy site infection: A prospective, randomized, open, blinded end-point (PROBE) design.


- candidate number8833
- NTR NumberNTR2667
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR27-dec-2010
- Secondary IDsGE10-09 
- Public TitleExploring alternative wound care treatment for percutaneous gastrostomy site infection: A prospective, randomized, open, blinded end-point (PROBE) design.
- Scientific TitleExploring alternative wound care treatment for percutaneous gastrostomy site infection: A prospective, randomized, open, blinded end-point (PROBE) design.
- ACRONYMPEG- Protocol
- hypothesisModern dressings containing silver are more effective than topical antibiotic treatment for healing of PEG-site infections.
- Healt Condition(s) or Problem(s) studiedPEG-site infections
- Inclusion criteria1. 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);
3. Male and female participants age 18 and older;
4. PEG insertion procedure longer than 1 week prior to randomization;
5. Patient or guardian is able to fully comprehend and perform study procedures.
- Exclusion criteria1. Estimated life expectancy less than one month;
2. Concurrent use of oral antibiotics for other diagnosis;
3. Signs and symptoms of concurrent disease for which the subject is expected to start antibiotic treatment.
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-feb-2011
- planned closingdate1-feb-2012
- Target number of participants30
- InterventionsGroup 1: Standard treatment with local antibiotic ointment (Fucidin ointment);
Group 2: Treatment with silver-impregnated dressing (Atrauman AG).
- Primary outcomeThe primary outcome will be the reduction or increase in peristomal sepsis scoring in both groups using the scoring scale of Jain et al.
- Secondary outcome1. The number of patients in which the PEG - site infection was regarded as healed;
2. Percentage decrease in number of bacterial species as measured by the IS-pro;
3. Treatment related adverse events;
4. Recurrence of infection 1 week after healing;
5. Deterioration of the infection-site that will require withdrawal.
- TimepointsThe primary endpoint will be evaluated by a blinded assessor two weeks after treatment.
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIES Esmé Clasquin
- CONTACT for SCIENTIFIC QUERIESDr. A.A. Bodegraven, van
- Sponsor/Initiator VU University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
VU University Medical Center
- PublicationsN/A
- Brief summaryTo determine the efficacy of silver impregnated dressings compared to a topical antibiotic to treat patients with PEG-site infections.
- Main changes (audit trail)
- RECORD27-dec-2010 - 30-jun-2012


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