Prospective pilot study: evaluation of a new dressing for patients treated in peritoneal dialysis

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr Robert Milongo
Scientific

AGDUC
Hôpital La Tronche
Grenoble
38 700
France

Primary study design	Observational
Study design	Monocentric, open, comparative study
Secondary study design	Single-centre
Scientific title
Study objectives	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.
Health condition(s) or problem(s) studied	Chronic renal failure
Intervention	Evaluation of dressing advantages via questionnaires
Intervention type	Other
Primary outcome measure(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).
Key secondary outcome measure(s)	Handling is also evaluated via the patient questionnaire. The incidence of Adverse Events (AE) will be followed during the study period.
Completion date	25/11/2006

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	20
Key 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
Key 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
Date of first enrolment	25/09/2006
Date of final enrolment	25/11/2006

AGDUC

Grenoble
38 700
France

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan