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Comparison of clobetasol with nitroglycerin ointment on prevention of superficial phlebitis in patients admitted to the man surgical ward

Protocol summary

Summary
The aim of this study was to compare the effect of nitroglycerin ointment with clobetasol ointment in the prevention of phlebitis is catheter place. This study is a clinical trial, randomized, double-blinded on145 men patients admitted to the surgical ward of Vali-asr hospital of Arak city ,that inclusion criteria (age between 20 and 60 years, patients with upper limb is health; requires 72 hours IV catheter; lack of phlebitis at the site of venipuncture, etc.) , is done. patients are divided in three group: A (clobetasol), B (NTG) and C (control). Data collection included demographic and medical questionnaire and degree of phlebitis checklist. Based on the amount of 2 grams of drugs for patients in the study group after venipuncture in the area of 2 × 4 cm distal of catheter then rubbed with gauze coated with hypoallergenic adhesive. According phlebitis symptoms include redness, warmth, pain, swelling and venous cording at 24,48 and 72 hours after venipuncture checked. If patients early discharge from hospital , acute infection or lack of full cooperation with researchers of the study, is eliminated..

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013051313301N2
Registration date: 2013-12-02, 1392/09/11
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-12-02, 1392/09/11
Registrant information
Name
Mahdi Mohseni
Name of organization / entity
Lorestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 66 1620 0140
Email address
mohseni_m1989@yahoo.com
Recruitment status
Recruitment complete
Funding source
Lorestan University of Medical Sciences and Health Services
Expected recruitment start date
2013-11-12, 1392/08/21
Expected recruitment end date
2014-01-11, 1392/10/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of clobetasol with nitroglycerin ointment on prevention of superficial phlebitis in patients admitted to the man surgical ward
Public title
Effect of Clobetasol and nitroglycerin ointment on inflammation caused by venipuncture
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria : Age between 20 and 60 years ; patients with upper limb is health ; the patient will require at least 72 hours to catheter venous; The patient has no previous phlebitis at the IV insertion site ; IV placement must be used catheter ;alcohol as a disinfectant before use catheter for disinfectant; catheter intravenous is not connected heparin lock, the patient is not allergic to the medication and adhesives ; patients with acute or chronic infectious diseases ; patients with personal history of vascular disease systemic disease, diabetes , skin disease, severe anemia , glaucoma , hypotension ( systolic pressure less than 100 mm Hg ); Patients with impaired immune systems; patients not taking anticoagulant medication . Exclusion criteria : early discharge from hospital; acute infection , lack of full cooperation with investigators .
Age
From 20 years old to 60 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 145
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Arak University of Medical Sciences
Street address
Department of Education and Research, Educational Complex campus, Basij Square, Sardasht.
City
arak
Postal code
381481-7-6941
Approval date
2013-11-11, 1392/08/20
Ethics committee reference number
92-154-2

Health conditions studied

1

Description of health condition studied
phlebitis
ICD-10 code
I80.8
ICD-10 code description
Phlebitis and thrombophlebitis of other sites

Primary outcomes

1

Description
Phlebitis
Timepoint
After Intervention every 24 hours for three days
Method of measurement
check list

Secondary outcomes

1

Description
Prevention of phlebitis
Timepoint
post and every 24 hours for three days
Method of measurement
check list

Intervention groups

1

Description
The intervention group clobetasol Ointment 0.05% ): After selecting the desired vein and disinfected with 70% Ethanol , the catheter was fixed to the skin. The distal portion of the catheter by clobetasol Ointment and dressings are impregnated century . cathter portion was assessed each 24 hour and In the absence of previous phlebitis and clean again with the ointment clobetasol ointment and a bandage is applied in the same area.
Category
Treatment - Drugs

2

Description
The intervention group Nitroglycerin Ointmentl): After selecting the desired vein and disinfected with 70% Ethanol and paste the catheter was fixed to the skin. The distal portion of the catheter by Nitroglycerin Ointment and dressings are impregnated century . cathter portion was assessed each 24 hour and In the absence of previous phlebitis and clean again with the nitroglycerin ointment and a bandage is applied in the same area .
Category
Treatment - Drugs

3

Description
The control group c: After selecting the desired vein and disinfected with 70%Ethanol and paste the catheter was fixed to the skin.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Vali Asr Hospital
Full name of responsible person
Hamid akbari
Street address
Imam Khomeini Ave, Vali Asr Square
City
arak

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Lorestan University of Medical Sciences,Research
Full name of responsible person
Dr. Mohamed Hossein Kaiedi
Street address
Lorestan University of Medical Sciences
City
Khorramabad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Lorestan University of Medical Sciences,Research
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
Lorestan University of Medical Sciences
Full name of responsible person
Hamid Akbari
Position
Masters Student-Critical Care
Other areas of specialty/work
Street address
Lorestan University of Medical Sciences, School of Nursing and Midwifery
City
Khorramabad.
Postal code
Phone
+98 66 1620 0140
Fax
+98 66 1620 0138
Email
akbari.5008@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Lorestan University of Medical Sciences
Full name of responsible person
Shahin Raufi
Position
masterscience
Other areas of specialty/work
Street address
Lorestan University of Medical Sciences, School of Nursing and Midwifery
City
Khorramabad
Postal code
Phone
+98 66 1620 0140
Fax
+98 66 1620 0138
Email
shahinraoufi@lums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Lorestan University of Medical Sciences
Full name of responsible person
Hamid Akbari
Position
Master of Nursing Student-Critical care Field
Other areas of specialty/work
Street address
Lorestan University of Medical Sciences, School of Nursing and Midwifery
City
Khorramabad
Postal code
Phone
+98 66 1620 0140
Fax
+98 66 1620 0138
Email
akbari.5008@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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