No registrations found.
ID
Source
Brief title
Health condition
PEG-site infections
Infectie van de PEG-insteekopening
Sponsors and support
Intervention
Outcome measures
Primary outcome
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
1. 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.
Background summary
To determine the efficacy of silver impregnated dressings compared to a topical antibiotic to treat patients with PEG-site infections.
Study objective
Modern dressings containing silver are more effective than topical antibiotic treatment for healing of PEG-site infections.
Study design
The primary endpoint will be evaluated by a blinded assessor two weeks after treatment.
Intervention
Group 1: Standard treatment with local antibiotic ointment (Fucidin ointment);
Group 2: Treatment with silver-impregnated dressing (Atrauman AG).
Esmé Clasquin
Amsterdam 1081 HV
The Netherlands
+31 (0)20 4449455
mdl.research@vumc.nl
Esmé Clasquin
Amsterdam 1081 HV
The Netherlands
+31 (0)20 4449455
mdl.research@vumc.nl
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);
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 criteria
1. 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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL2549 |
| NTR-old | NTR2667 |
| Other | : GE10-09 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |