Protocol summary

Study aim
Determining the effect of Dorema Ammoniacum cream on the prevention of phlebitis caused by peripheral venous catheters in patients admitted to the surgical wards of Shariati Hospital
Design
Clinical trial has two groups of intervention (Dorema Ammoniacum cream) and control (cream base). Assignment of samples to two groups with a random permutation block design will be two treatments with quadruple blocks. The study is three-way blind and the sample size is 55 people in each group.
Settings and conduct
This study is a three-blind randomized clinical trial in two groups. The patient, the researcher, the research assistant and the statistical analyzer have no knowledge of how the cans are named and the contents inside. After analyzing the data, the cream manufacturer will be asked about the contents of the cans. The research will be performed in the surgical ward of Shariati Hospital in Tehran. The study population was all patients admitted to the surgical ward and the research sample was all patients with peripheral venous catheter and at risk of phlebitis.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Hospitalization in the surgical ward The patient is alert and able to understand and describe pain Necessary desire and cooperation from the patient The age of the samples is between 18 and 60 years Exclusion criteria: Grade 2, 3 and 4 phlebitis Fever
Intervention groups
There are two intervention groups, the experimental group that receives the Dorema Ammoniacum cream and the control group that receives the cream base.
Main outcome variables
Degree of phlebitis

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20201119049441N1
Registration date: 2021-01-18, 1399/10/29
Registration timing: prospective

Last update: 2021-01-18, 1399/10/29
Update count: 0
Registration date
2021-01-18, 1399/10/29
Registrant information
Name
zohreh hemmatpor
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6591 6096
Email address
z.hemmatpor@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-03, 1399/11/15
Expected recruitment end date
2021-06-05, 1400/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Dorema Ammoniacum Cream on the prevention of peripheral intravenous catheter-related phlebitis In patients admitted to surgery departments
Public title
Effect of Dorema Ammoniacum Cream on the prevention of peripheral intravenous catheter-related phlebitis In patients admitted to surgery departments
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Hospitalization in the surgical ward Implantation of a peripheral venous catheter in the upper limb, in a place without signs of phlebitis The patient is alert and able to understand and describe pain Necessary desire and cooperation from the patient The age of the samples is between 18 and 60 years No diabetes No skin disorders and eczema Lack of sensitivity to peripheral venous catheter adhesive Lack of chemotherapy No acute infectious diseases
Exclusion criteria:
Grade 2, 3 and 4 phlebitis Fever
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 110
Randomization (investigator's opinion)
Randomized
Randomization description
After adapting the patient's condition to the inclusion criteria, patients are randomly assigned to one of the two experimental or control groups. Thus, the letter A is considered for the intervention group and the letter B is considered for the control group. Then we write all the permutation combinations of the letters A, A, B and B, which are 6 different combinations, on 6 cards as follows: AABB, ABBA, ABAB, BAAB, BABA, BBAA, then we randomly select a digit from 1 to 6 (With the help of a table of random numbers or we ask patient number one to choose a card at random). For example, if the number 2 is selected, it means that the first person in the intervention group will be the next two people in the control group and the fourth person in the intervention group, and we will continue this operation until the sample size reaches the quorum.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The blinding of the study is that the Dorema Ammoniacum cream and placebo made by the research team are both completely similar in terms of color, odor, consistency and cans used, and the cans are named A and B by the cream maker. The patient, the researcher and the assistant researcher and the statistical analyzer have no information about how to name the cans and the contents inside them, and finally, after analyzing the data, the manufacturer of the cream will be asked about the contents of the cans.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of the School of Nursing and Midwifery, Tehran University of Medical Sciences
Street address
Tehran, Tohid Square, Dr. Mirkhani St. (Eastern Nusrat), School of Nursing and Midwifery
City
tehran
Province
Tehran
Postal code
1419733171
Approval date
2020-10-20, 1399/07/29
Ethics committee reference number
IR.TUMS.FNM.REC.1399.116

Health conditions studied

1

Description of health condition studied
Phlebitis
ICD-10 code
180.8
ICD-10 code description
Phlebitis and thrombophlebitis of other sites

Primary outcomes

1

Description
Degree of phlebitis
Timepoint
Determining the degree of phlebitis at 12, 24, 36, 48, 60 and 72 hours after implantation of peripheral venous catheter and application of Dorema Ammoniacum cream.
Method of measurement
The VIP Infusion Visual Scale Checklist for Phlebitis was developed to assess the position around the peripheral venous catheter for phlebitis and was rated from 0 (no phlebitis) to 5 (advanced thrombophlebitis). Evidence of phlebitis that can be observed and examined for scoring has been stated and action that is appropriate for that stage of phlebitis has been stated.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In the intervention group, Dorema Ammoniacum cream is used. To prepare Dorema Ammoniacum cream, 100 grams of Dorema Ammoniacum resin oleogum is weighed and ground. 1 liter of 70 degree alcohol is added to it. Clears after 48 hours. Add another liter of alcohol and strain it again after 48 hours. The filtered solution is concentrated by rotary rotation. The concentrated solution is placed in a vacuum oven to form a powder. 5 g of the powder with 20 cc of distilled water is placed in an ultrasonic bath for 15 minutes to obtain a uniform liquid. A uniform liquid is added to 100 g of the base cream and it is beaten evenly with an electric mixer to obtain a uniform cream. It is then packed in 50 g containers. 70% alcohol is used only for extraction and after drying the extract, nothing of alcohol remains in the extract. Before using the cream, a skin allergy test is performed, in which some cream is rubbed on the patient's arm and after For 20 minutes the position is examined for redness, rash and other allergic reactions, and if there is no reaction, the drug will be tested on the patient. The product is standardized by spectrophotometric method based on the amount of spirochete compounds of terpenoic chromium acid 2-4-dione. Ash essential oil is also isolated and its compounds are identified by GC-MS. According to the European Pharmacopoeia, skin-mucosal products do not need to be sterilized.
Category
Prevention

2

Description
Control group: The base cream is prepared by Farabi company and consists of Vaseline, glycerin, monostearate, beeswax, lanolin, stearic acid, alcohol, distilled water, triethanolamine. To prepare the placebo, the base cream is in 50 containers. It is warmly packaged. Before using the cream, a skin allergy test is performed, in which some cream is rubbed on the patient's arm, and after 20 minutes, the position for redness, rash and other allergic reactions is examined. If there is no reaction, the drug will be tested on the patient.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Shariati Hospital
Full name of responsible person
Hemmatpor Zohreh
Street address
Shariati Hospital., Jalal Al-Ahmad Intersection., North Kargar St., Tehran in front of the Faculty of Economics,.
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Email
shariatihosp@tums.ac.ir
Web page address
http://shariati.tums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Sahraeian, Mohammad Ali
Street address
Imam Khomeini Ave., Hasan Abad Sq., Sina Hospital Tehran – Iran
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6670 6142
Email
msahrai@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Hemmatpor, Zohreh
Position
Nursing Graduate Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 7.2, First Floor, Unit 2, West 1st Arghavan St., Doniamali Blvd., 1st phase of andishe., Shahriar, Tehran.
City
Tehran
Province
Tehran
Postal code
3354462338
Phone
+98 21 6591 6096
Email
z.hemmatpor@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hemmatpor, Zohreh
Position
Nursing Graduate Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 7.2, First Floor, Unit 2, West 1st Arghavan St., Doniamali Blvd., 1st phase of andishe., Shahriar, Tehran.
City
Tehran
Province
Tehran
Postal code
3354462338
Phone
+98 21 6591 6096
Email
z.hemmatpor@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hemmatpor, Zohreh
Position
Nursing Graduate Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 7.2, First Floor, Unit 2, West 1st Arghavan St., Doniamali Blvd., 1st phase of andishe., Shahriar, Tehran.
City
Tehran
Province
Tehran
Postal code
3354462338
Phone
+98 21 6591 6096
Email
z.hemmatpor@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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