Condition category
Urological and Genital Diseases
Date applied
23/08/2006
Date assigned
30/10/2006
Last edited
19/09/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Robert Milongo

ORCID ID

Contact details

AGDUC
Hôpital La Tronche
Grenoble
38 700
France

Additional identifiers

EudraCT 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

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

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Chronic renal failure

Intervention

Evaluation of dressing advantages via questionnaires

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

25/09/2006

Overall trial end date

25/11/2006

Reason abandoned

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

Patient

Age group

Adult

Gender

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

Trial 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

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes