Chronic renal failure Urological and Genital Diseases Chronic renal failure
Conditions
Interventions
Evaluation of dressing advantages via questionnaires
Sponsors
Gambro Industries (France)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with well healed exit site 2. Patients treated for at least three months in peritoneal dialysis irrespective of the treatment mode 3. Patients with healthy skin judged by investigator 4. Patients aged 18 years and older 5. Patients having signed a written consent (informed consent) to participate in the study
Exclusion criteria
Exclusion criteria: 1. Patients treated in hemodialysis 2. Patients with diagnosed abdominal pain not related with PD-solution 3. Peritonitis within one month prior to the study 4. Presence of exit-site, tunnel infection 5. Patients with ongoing peritonitis 6. Patients participating in other studies during the period of this study 7. Patients practising swimming 8. Patients under guardianship 9. Pregnancy, lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dressing advantages are evaluated via questionnaires, which have to be filled in at specific time schedule. Comfort and safety evaluation will be performed by the patient at the end of each period of product use (end of PD Immo use and end of usual dressing use). | — |
Secondary
| Measure | Time frame |
|---|---|
| Handling is also evaluated via the patient questionnaire. The incidence of Adverse Events (AE) will be followed during the study period. | — |
Countries
France
Outcome results
None listed