Protocol summary

Study aim
Comparison of the effect of aloe vera and nitroglycerine ointment on the incidence and severity of phlebitis induced by peritoneal veins catheter in patients admitted to internal wards of Sanandaj Kowsar Hospital in 1397
Design
clinical trial
Settings and conduct
Kowsar Hospital Sanandaj
Participants/Inclusion and exclusion criteria
Entry Requirements: Hospitalization in the internal part for at least 48 hours, voluntary participation in the study, 20 to 70 years of age, having a healthy upper limb, requiring 48 hours of intravenous catheter, absence of phlebitis in the site before insertion of the angioquate, failure to receive injurious medications to the artery wall (Diazepam, midazolam, amiodarone, vitamin C, levofloxacin and ciprofloxacin), non-use of anticoagulants, the use of alcohol as an antiseptic prior to the administration of the catheter, as well as a history of vascular, systemic, diabetes, skin disease, diseases Acute and severe infections, severe anemia, glaucoma, hypotension (systolic pressure less than 100 mm) . Immune deficiency, no chemotherapy, no intravenous feeding. The type of catheter is angioquate and not attached to heparin lacquer. Conditions for not admitting to the study: discharge from the hospital two days after the start of the intervention, unwillingness to continue cooperation in the study, lack of proper and timely use of the Aloe vera and nitroglycerine ointment during the study, rupture or withdrawal of the angiocontection before 48 hours , Getting sick for any reason and getting the intravenous line in the same.
Intervention groups
Group A of Aloe Vera Powder was manufactured by Arian Kimia Co., and in group B, nitroglycerin ointment was manufactured by Torika Company at a concentration of 2% in the upper part of the Angiocate area in the width of 2 × 4 cm and covered with sterile coating (angioutic glue) Will be worn.
Main outcome variables
phlebitis

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20181204041845N1
Registration date: 2019-07-15, 1398/04/24
Registration timing: retrospective

Last update: 2019-07-15, 1398/04/24
Update count: 0
Registration date
2019-07-15, 1398/04/24
Registrant information
Name
samira mohammadian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 87 3372 5645
Email address
mohammadian.s@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-20, 1396/12/29
Expected recruitment end date
2019-03-20, 1397/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative Study on the Effect of Aloe Vera and Nitroglycerin Powder on the incidence and severity of phlebitis caused by peritoneal catheter
Public title
Comparative Study on the Effect of Aloe Vera and Nitroglycerin Powder on the incidence and severity of phlebitis caused by peritoneal catheter
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Hospitalization in the internal part for at least 48 hours, voluntary participation in the study, 20 to 70 years of age, having a healthy upper limb, requiring 48 hours of intravenous catheter, absence of phlebitis in the site before insertion of the angioquate, failure to receive injurious medications to the artery wall (Diazepam, midazolam, amiodarone, vitamin C, levofloxacin and ciprofloxacin), non-use of anticoagulants, the use of alcohol as an antiseptic prior to the administration of the catheter, as well as a history of vascular, systemic, diabetes, skin disease, diseases Acute and severe infections, severe anemia, glaucoma, hypotension (systolic pressure less than 100 mm) More mercury). Immune deficiency, no chemotherapy, no intravenous feeding. The type of catheter is angioquate and not attached to heparin lacquer.
Exclusion criteria:
Conditions for not admitting to the study: discharge from the hospital two days after the start of the intervention, unwillingness to continue cooperation in the study, lack of proper and timely use of the Aloe vera and nitroglycerine ointment during the study, rupture or withdrawal of the angiocontection before 48 hours , Getting sick for any reason and getting the intravenous line in the same.
Age
From 20 years old to 70 years old
Gender
Both
Phase
0
Groups that have been masked
  • Participant
Sample size
Target sample size: 150
Randomization (investigator's opinion)
Randomized
Randomization description
اPatients will be selected by simple sampling method and will be divided into three groups: A (nitroglycerin), B (Aloe Vera), and (C) by simple random allocation in the groups using the four-block software.
Blinding (investigator's opinion)
Single blinded
Blinding description
اIn this one-sided study, only participants are unaware of the allocation of study groups.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
kurdistan university of medical science
Street address
Kurdistan University of Medical Sciences, lower than Ghods Hospital, Pasdaran Avenue
City
sanandaj
Province
Kurdistan
Postal code
6618634683
Approval date
2018-12-25, 1397/10/04
Ethics committee reference number
IR.MUK.REC.1397.261

Health conditions studied

1

Description of health condition studied
phlebitis
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Phlebitis
Timepoint
هر 12 ساعت پس از مداخله به مدت48ساعت
Method of measurement
5-degree phlebitis observation scale

Secondary outcomes

1

Description
Cutaneous complications
Timepoint
Every 12 hours for 48 hours
Method of measurement
see

Intervention groups

1

Description
Intervention group:
Category
Prevention

2

Description
Intervention group:
Category
Prevention

3

Description
Control group:
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Kowsar Hospital
Full name of responsible person
Samira Mohammadian
Street address
Kurdistan University of Medical Sciences, lower than Ghods Hospital, Pasdaran Avenue
City
sanandaj
Province
Kurdistan
Postal code
6618634683
Phone
+98 87 3182 7272
Fax
+98 87 3366 4651
Email
samiraavin@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Mohammad Fathi
Street address
Kurdistan University of Medical Sciences, lower than Ghods Hospital, Pasdaran Avenue
City
Sanandaj
Province
Kurdistan
Postal code
6618634683
Phone
+98 87 3362 7636
Email
fathi_sanan@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sanandaj University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Mohammad Fathi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Kurdistan University of Medical Sciences, lower than Ghods Hospital, Pasdaran Avenue
City
Sanandaj
Province
Kurdistan
Postal code
6618634683
Phone
+98 87 3362 7636
Email
fathi_sanan@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Mohammad Fathi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Kurdistan University of Medical Sciences, lower than Ghods Hospital, Pasdaran Avenue
City
Sanandaj
Province
Kurdistan
Postal code
6618634683
Phone
+98 87 3362 7636
Email
fathi_sanan@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Samira Mohammadian
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Kurdistan University of Medical Sciences, lower than Ghods Hospital, Pasdaran Avenue
City
Sanandaj
Province
Kurdistan
Postal code
6618634683
Phone
+98 87 3182 7272
Email
samiraavin@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The whole potential data is unpublished after being unidentifiable
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
Researchers working in academia and academia
Under which criteria data/document could be used
1
From where data/document is obtainable
1
What processes are involved for a request to access data/document
1
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