A comparative study of two dressing techniques the sterile gauze dressing and the routine dressing method (leucoplast) in incidence and intensity of phlebitis associated with peripheral intravenous catheter site.
The purpose of this research is the study of the comparison between sterile gauze dressing method and the routine dressing method (leucoplast) in incidence and intensity of phlebitis associated with peripheral intravenous catheter site.80 bedridden patients in internal sections heart, CCU and PCCU in Imam Ali Cardiovascular center in Kermanshah put in two sampling groups of sterile gauze dressing or leucoplast based on blind randomizing. Place dressing in both groups is in the same way. After catheter placement, every 24 hours in a maximum of 72 hours period, the Status area phlebitis checked by using check list examination and observed by a researcher who does not know the patient groups. All of the samples of research trained in a same way for catheter care. Also there are reported a fixed instruction about dilution and constant infusion rate of intravenous drugs in patient’s card and nurse report. After gathering information, it will be analyzed by 16th version of SPSS software and inferential statistics test cases
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201101085564N1
Registration date:2011-04-10, 1390/01/21
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-04-10, 1390/01/21
Registrant information
Name
fateme Hadadian Chaqayy
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1826 9394
Email address
fhadadian@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice – Chancellery of Research & Technology Affairs of Kermanshah University of Medical Sciences
Expected recruitment start date
2010-09-11, 1389/06/20
Expected recruitment end date
2011-01-20, 1389/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of two dressing techniques the sterile gauze dressing and the routine dressing method (leucoplast) in incidence and intensity of phlebitis associated with peripheral intravenous catheter site.
Public title
A comparative study of two dressing techniques the sterile gauze dressing and the routine dressing method (leucoplast) in incidence and intensity of phlebitis associated with peripheral intravenous catheter site.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Having serum or IV medicine; Having no sensitivity to Leucoplast, Iodine or other medicines; Having no blood transfusion; having normal skin in the site that insert intravenous catheter; having no IV infusion of Hypertonic serum, having Systolic blood pressure upper 90 mm/Hg.
Exclusion criteria: The patient discharging or expiring, before 72 hours insert intravenous catheter
Age
From 20 years old to 90 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
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
Kermanshah University of Medical Sciences, Vice – Chancellery of Research & Technology Affairs
Street address
Medical Science building No.2, In front of Imam Ali cardiovascular center, Shahid Beheshti Blvd., Kermanshah, Iran
City
Kermanshah
Postal code
Approval date
2010-10-05, 1389/07/13
Ethics committee reference number
6966
Health conditions studied
1
Description of health condition studied
phlebitis
ICD-10 code
Z45.2
ICD-10 code description
Adjustment and management of vascular access device
Primary outcomes
1
Description
incidence of phlebitis
Timepoint
24,48,72 hourse after catheter placement
Method of measurement
phlebitis scale
2
Description
intensity of phlebitis
Timepoint
24,48,72 hourse after catheter placement
Method of measurement
phlebitis scale
Secondary outcomes
empty
Intervention groups
1
Description
In the intervention group after putting a new catheter, 5 × 5 cm sterile gauze is placed in the place of catheter and then will be fixed by leucoplast. If we made a mistake to put the catheter more than one time, we select a new location for injecting a new catheter. After catheter placement, for knowing the place of phlebitis symptoms, every 24 hours in a 72 hours period, the Status area is checked by a nurse who is unaware about patient group
Category
Treatment - Drugs
2
Description
In the control group after putting a new catheter the place will be fixed only by Leucoplast (Which typically used in Iran’s/Kermanshah’s hospitals now). In this group, like intervention group, if we made a mistake to put the catheter more than one time, we select a new location for injecting a new catheter. After catheter placement, for knowing the place of phlebitis symptoms, every 24 hours in a 72 hours period, the Status area is checked by a nurse who is unaware about patient group
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Ali cardiovascular center in Kermanshah – Iran
Full name of responsible person
Kadivar Sakeine
Street address
Imam Ali cardiovascular center, Shahid Beheshti Blvd. Kermanshah
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences, Vice – Chancellery of Research & Technology Affairs
Full name of responsible person
Doctor Farid Najafi
Street address
Kermanshah University of Medical Sciences,Vice – Chancellery of Research & Technology Affairs
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah University of Medical Sciences, Vice – Chancellery of Research & Technology Affairs
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
Kermanshah University of Medical Sciences
Full name of responsible person
F.Hadadian chaqayy
Position
MS in Medical Surgical Nursing / faculty mentor
Other areas of specialty/work
Street address
Nursing Midwifery school, Kermanshah University of Medical Sciences, kermanshah - Iran
City
Kermanshah
Postal code
Phone
+98 83 1828 2102
Fax
Email
fhadadian@kums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
F. Hadadian Chaqayy
Position
MS in Medical Surgical Nursing / faculty mentor
Other areas of specialty/work
Street address
Nursing Midwifery school, Kermanshah University of Medical Sciences, kermanshah - Iran
City
kermanshah
Postal code
Phone
+98 83 1828 2102
Fax
Email
fhadadian@kums.ac.r
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
F. Hadadian Chaqayy
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)