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

ISRCTN	ISRCTN34049135
DOI	https://doi.org/10.1186/ISRCTN34049135
Secondary identifying numbers	1445

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

Study design	Monocentric, open, comparative study
Primary study design	Observational
Secondary study design	Single-centre
Study setting(s)	Not specified
Study type	Treatment
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	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
Completion date	25/11/2006

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	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

Gambro Industries (France)
Industry

Clinical Affairs Department
61 Avenue Tony Garnier
Lyon
69 007
France

Website	http://www.gambro.com/start.aspx?id=752
"ROR"	https://ror.org/01mgtdr23

Industry

Gambro Industries (France)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan