1-Purpose: This study has been conducted to determine the effect of topical using Rosmarinus ointment on the incidence and severity of phlebitis due to antibiotic therapy in Intensive Care Units. 2-Plan: After getting permission from Ahvaz Jundishapur University of Medical Sciences and submitting it to the President of Dr. Ganjavian Hospital of Dezful and the Head of the ICU department,46,18 to 60 year-old patients who have inclusion criteria have been selected within three months. 3- Methods: 46 patients with antibiotic therapy, who admitted to Intensive Care Unit, were enrolled in a clinical trial and they randomly divided in two equal, control & intervention, groups.4-Inclusion criteria:18-60 years ; antibiotic therapy management with Cefteriaxon and Vancomycin; Application No. 20-18 catheter Supa Company; catheterization into arm vein; No septic conditions during catheterization.
5-Interventions:They will use 2/8 gr of Rosmarinus ointment every 12 hours, two times a day, from the first day of admitted up to the third day.
Exclusion criteria: underlying fever and neutropenia;received another Vegetable oil or drug; no sing of allergy
6-Incidence and severity of phlebitis were assesed in 24,48 and 72 hours after catheterization.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016021914930N5
Registration date:2016-05-21, 1395/03/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-05-21, 1395/03/01
Registrant information
Name
Marzieh Beigom Bigdeli Shamloo
Name of organization / entity
Dezful Medical Sciences University
Country
Iran (Islamic Republic of)
Phone
+98 61 4252 3912
Email address
m.bigdeli@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2016-01-21, 1394/11/01
Expected recruitment end date
2016-03-20, 1395/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of topical using Rosmarinus ointment on the incidence and severity of phlebitis due to antibiotic therapy in Intensive Care Units
Public title
Effect of Rosmarinus ointment on phlebitis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:18-60 years ; antibiotic therapy management with Cefteriaxon and Vancomycin; Application No. 20-18 catheter Supa Company; catheterization into arm vein; No septic conditions during catheterization.
Exclusion criteria: underlying fever and neutropenia;received another Vegetable oil or drug; no sing of allergy
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
46
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Committee of Vice chancellor for Research of Ahvaz Jundishapur University of Medical Sciences
Street address
vic Research of Ahwaz Joundi Shapoor Medical Sciences University, Golestan, Ahwaz
City
Ahwaz
Postal code
Approval date
2016-04-04, 1395/01/16
Ethics committee reference number
IR.AJUMS.REC.1394.735
Health conditions studied
1
Description of health condition studied
phlebitis
ICD-10 code
I98*
ICD-10 code description
Other disorders of circulatory system in diseases classified elsewhere
Primary outcomes
1
Description
phlebitis incidence
Timepoint
24,48,72
Method of measurement
phlebitis numerical scale
Secondary outcomes
1
Description
phlebitis severity
Timepoint
24,48,72
Method of measurement
phlebitis numberical scale
Intervention groups
1
Description
2/8 gr of Rosmarinus ointment for topical using, every 12 hours, two times a day, from the first day of antibiotic therapy up to the third day
Category
Prevention
2
Description
2/8 gr of Oserin ointment for topical using, every 12 hours, two times a day, from the first day of antibiotic therapy up to the third day
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Chronic Disease Care Research Center - Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Marziyeh Asadi Zaker
Street address
Chronic Disease Care Research Center - Ahvaz Jundishapur University of Medical Sciences Ahvaz ,Iran
City
Dezful
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for Research of Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Mojdeh Dezfuli
Street address
Ahvaz Jundishapur University of Medical Sciences-Golestan mini city-Ahwaz
City
Ahwaz
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 of Ahvaz Jundishapur 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
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Marziyeh Asadi Zaker
Position
PHD- Assistance Professor
Other areas of specialty/work
Street address
Chronic Disease Care Research Center - Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Postal code
Phone
+98 613738622
Fax
Email
maraiehasdizaker@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Marzieh Asadi Zaker
Position
PHD- Assistance Professor
Other areas of specialty/work
Street address
Dr Ganjavian Hospital, Dezful_Andimeshk road
City
Ahvaz
Postal code
-------
Phone
+98 916 615 9157
Fax
Email
maraiehasdizaker@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Abbass Sheykhi
Position
Student of Mastery in Critical Care Nursing
Other areas of specialty/work
Street address
Nursing and Midwifery School-Ahvaz Jundishapur University of Medical Sciences-Ahvaz
City
Ahvaz
Postal code
---------
Phone
+98 61336754360
Fax
Email
Sheykhi.Abbass@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)