Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
1445
Study information
Scientific title
Acronym
Study hypothesis
Evaluation of a new Peritoneal Dialysis (PD) dressing.
Ethics approval(s)
Submitted to CPP Grenoble (reference number: 06-GAMB-1), will receive verdict on 20th September 2006.
Study design
Monocentric, open, comparative study
Primary study design
Observational
Secondary study design
Single-centre
Study setting(s)
Not specified
Study type
Treatment
Patient information sheet
Condition
Chronic renal failure
Intervention
Evaluation of dressing advantages via questionnaires
Intervention type
Other
Primary outcome measure
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 measures
Handling is also evaluated via the patient questionnaire.
The incidence of Adverse Events (AE) will be followed during the study period.
Overall study start date
25/09/2006
Overall study end date
25/11/2006
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
Both
Target number of participants
20
Participant 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
Recruitment start date
25/09/2006
Recruitment end date
25/11/2006
Locations
Countries of recruitment
France
Study participating centre
AGDUC
Grenoble
38 700
France
Sponsor information
Organisation
Gambro Industries (France)
Sponsor details
Clinical Affairs Department
61 Avenue Tony Garnier
Lyon
69 007
France
Sponsor type
Industry
Website
http://www.gambro.com/start.aspx?id=752
ROR
Funders
Funder type
Industry
Funder name
Gambro Industries (France)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|