To study preventive effect of disinfectant solutions (alcohol, povidone - Iodine, and chlorhexidine - alcohol) on catheter insertion places in 123 patients who need IV line at internal wards of Beasat hospital, Sanandaj, Iran. Patients were randomly divided into 3 groups: alcohol, povidone - Iodine, and chlorhexidine - alcohol group. Catheter entry points were evaluated for phlebitis after 48 to 72 hours.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138901263726N1
Registration date:2008-08-16, 1387/05/26
Registration timing:retrospective
Last update:
Update count:0
Registration date
2008-08-16, 1387/05/26
Registrant information
Name
Shoaleh Shami
Name of organization / entity
Nursing school, Kurdistan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 87 1666 3728
Email address
shole.shami@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Kurdistan university of medical sciences
Expected recruitment start date
2008-08-16, 1387/05/26
Expected recruitment end date
2009-02-16, 1387/11/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative evaluation of preventive effects of ethanol, chlorhexidine-ethanol, and iodine –piodine on peripheral venous catheter induced phlebitis
Public title
Comparison the preventive effects of three different antiseptic agents on creation of phlebitis in peripheral catheter insertion site
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: age between 20-60, need to IV line, conscious patients, exact upper limb. Exclusion criteria: pregnancy, vascular disease, diabetes, severe anemia, headache, glaucoma, high intracranial pressure, hypotension, anticoagulant therapy, corticosteroid therapy.
Age
From 25 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
123
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kurdistan university of medical sciences
Street address
Pasdaran Blv
City
Sanandaj
Postal code
Approval date
2008-07-01, 1387/04/11
Ethics committee reference number
پ14پ3755
Health conditions studied
1
Description of health condition studied
phlebitis and infection of peripheral catheter insertion site following preparation the skin with various anti-septic agents
ICD-10 code
T81.6
ICD-10 code description
Acute reaction to foreign substance accidentally left during a procedure
Primary outcomes
1
Description
phlebitis
Timepoint
48 and 72 hour after chateter insertion
Method of measurement
0= absence of any clinical symptoms; 1= erythema, with or without pain; 2- pain, erythema, edema, or both together; 3- pain, erythema, edema, or both together, clear palpable vessel; 4- pain, erythema, edema, or both together, clear palpable vessel, and infectious discharge.
Secondary outcomes
empty
Intervention groups
1
Description
Disinfect the entry site of peripheral catheters by alcohol
Category
Prevention
2
Description
Disinfect the entry site of peripheral catheters by povidone - Iodine
Category
Prevention
3
Description
Disinfect the entry site of peripheral catheters by chlorhexidine – alcohol
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Beasat hospital
Full name of responsible person
Mohamadkhani
Street address
Kheshavarz street
City
Sanandaj
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kurdistan university of medical sciences
Full name of responsible person
Attaaollah Haidari
Street address
Pasdaran BLV
City
Sanandaj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kurdistan 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
Nursing school
Full name of responsible person
Shoaleh Shami
Position
Master
Other areas of specialty/work
Street address
Jam Jam street
City
Sanandaj
Postal code
Phone
+98 87 1666 3728
Fax
+98 87 1666 0092
Email
shole.shami@muk.ac.ir
Web page address
muk.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Nursing school
Full name of responsible person
Shoaleh Shami
Position
Master
Other areas of specialty/work
Street address
Jam-Jam street
City
Sanandaj
Postal code
Phone
+98 87 1666 3728
Fax
+98 87 1666 3728
Email
shole.shami@muk.ac.ir
Web page address
muk.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Nursing school
Full name of responsible person
Shoaleh Shami
Position
Master
Other areas of specialty/work
Street address
Jam-Jam street
City
Sanandaj
Postal code
Phone
+98 87 1666 3728
Fax
+98 87 1666 3728
Email
shole.shami@muk.ac.ir
Web page address
muk.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)