The purpose of this study is to compare Gentamicin and Mupirucine ointment on the rate of peritonitis and the exit site infection in peritoneal dialysis. In this study, 120 patients who were on peritoneal dialysis for at least three months, did not receive systemic antibiotics in 30 days prior to the study, and without skin hypersensitivity to Gentamicin or Mupirucine were recruited after obtaining consent. The patients who were on hemodialysis or received transplantation were excluded. The patients received either Gentamicin 0.1% ointment or Mupirocine 2% ointment, manufactured Sinadaru pharmaceutical company, for 6 months. Frequency of peritonitis and catheter exit site infection rates were evaluated at the end of the study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201012282417N5
Registration date:2011-01-25, 1389/11/05
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-01-25, 1389/11/05
Registrant information
Name
Firouzeh Moeinzadeh
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1625 5555
Email address
moinzade@resident.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Isfahan University of Medical Sciences
Expected recruitment start date
2009-08-23, 1388/06/01
Expected recruitment end date
2010-02-20, 1388/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Gentamicin and Mupirucine ointments on the rate of peritonitis and exit site infection in peritoneal dialysis
Public title
Comparison of Gentamicin and Mupirucine ointments on the rate of peritonitis and exit site infection in peritoneal dialysis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age at least 18 years, at least 3 months on peritoneal dialysis, Satisfaction to participate in the study, lack of cutaneous hypersensitivity to gentamicin or Mupirocine ointments, Not receiving systemic antibiotics during the 30 days prior to the study
Exclusion criteria: systemic antibiotic treatment during the study, changing in dialysis route, transplantation or death, no satisfaction
Age
From 18 years old to 99 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences
City
Isfahan
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
388335
Health conditions studied
1
Description of health condition studied
End stage renal disease
ICD-10 code
N18.0
ICD-10 code description
End-stage renal disease
Primary outcomes
1
Description
Rate of peritonitis
Timepoint
monthly
Method of measurement
clinical symptoms and direct inspection of dialysis fluid
Secondary outcomes
1
Description
Raete of exit site infection
Timepoint
monthly
Method of measurement
clinical symptoms
Intervention groups
1
Description
Gentamicin 0.1% ointment daily on the catheter exit site of peritoneal dialysis for 6 months
Category
Treatment - Drugs
2
Description
Mupirocine 2% ointment daily on the catheter exit site of peritoneal dialysis for 6 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital peritoneal dialysis center
Full name of responsible person
Mrs Karimi
Street address
Isfahan. Sofe Ave. Alzahra hospital
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Isfahan University of Medical Sciences
Full name of responsible person
Vice Chancellor
Street address
Isfahan. Isfahan University of Medical Science
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Isfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr Mojgan Mortazavi
Position
Associate Professor of Nephrology
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Isfahan
City
Isfahan
Postal code
Phone
+98 31 1668 5555
Fax
Email
m_mortazavi@med.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr Mojgan Mortazavi
Position
Associate professor of Nephrology
Other areas of specialty/work
Street address
Isfahan University of Medical Science, Isfahan
City
Isfahan
Postal code
Phone
+98 31 1668 5555
Fax
Email
m_mortazavi@med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr Firouzeh Moeinzadeh
Position
Assistant of Internal Medicine
Other areas of specialty/work
Street address
Alzahra hospital, Isfahan
City
Isfahan
Postal code
Phone
+98 31 1668 5555
Fax
Email
fimoinzad@yahoo.commoinzade@resident.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)