|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ISRCTN |
|
Last refreshed on:
|
13 January 2015 |
|
Main ID: |
ISRCTN34049135 |
|
Date of registration:
|
30/10/2006 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Prospective pilot study: evaluation of a new dressing for patients treated in peritoneal dialysis
|
|
Scientific title:
|
|
|
Date of first enrolment:
|
25/09/2006 |
|
Target sample size:
|
20 |
|
Recruitment status: |
Completed |
|
URL:
|
http://isrctn.com/ISRCTN34049135 |
|
Study type:
|
Observational |
|
Study design:
|
Monocentric, open, comparative study (Treatment)
|
|
Phase:
|
|
|
|
Countries of recruitment
|
|
France
| | | | | | | |
|
Contacts
|
|
Name:
|
Robert
Milongo |
|
Address:
|
AGDUC
Hôpital La Tronche
38 700
Grenoble
France |
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
|
|
Name:
|
|
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
| |
|
Key inclusion & exclusion 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: 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
Age minimum:
Age maximum:
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
Chronic renal failure
Urological and Genital Diseases
Chronic renal failure
|
|
Intervention(s)
|
|
Evaluation of dressing advantages via questionnaires
|
|
Primary Outcome(s)
|
|
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 Outcome(s)
|
Handling is also evaluated via the patient questionnaire.
The incidence of Adverse Events (AE) will be followed during the study period.
|
|
Source(s) of Monetary Support
|
|
Gambro Industries (France)
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|