Comparison between the effect of Aleo Vera and Olive Oil preventive dressing usage on pressure injury development in critically ill patients who admitted to intensive care unit (ICU) of Velayat Teaching Hospital, Qazvin.
Determining of the effect of Aleo Vera and Olive Oil preventive dressing usage on pressure ulcer development in critically ill patients who admitted to intensive care unit (ICU) of Velayat Teaching Hospital, Qazvin
Design
Three arm parallel group, non-randomized, single-blind, controlled clinical trial
Settings and conduct
The present clinical trial study was designed to compare the effect of Aloe vera gel and olive oil preventive dressings on the development of pressure injury. The research setting will be the intensive care unit (ICU) of Velayat Teaching Hospital, Qazvin. This study seeks to include all patients admitted to intensive care units (ICUs) as long as they meet the inclusion criteria. In this study, eligible patients will be divided into three groups: 1. Aloe vera, 2. Olive oil, and 3. Control.
Participants/Inclusion and exclusion criteria
Inclusion: the patient or his/her family's informed consent to participate in the study; aged above 18 years old. The absence of pressure injury on arrival at ICU. Patients with moderate to high risk based on the score they achieved from the Braden criterion at entry (score 14 and below).
Exclusion criteria: pressure injury development within the first 12 hours after entering the ward. Conditions where the patient's position cannot be changed, such as patients with spinal cord injury. Drug sensitivity to Aleo Vera in group 1 and Olive oil in group 2 (according to patient or if sensitivity was observed in the study). Patient's death
Intervention groups
In this study, eligible patients will be divided into three groups: 1. Aloe vera, 2. Olive oil, and 3. Control.
Main outcome variables
Pressure ulcer development
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200105046008N1
Registration date:2020-08-05, 1399/05/15
Registration timing:registered_while_recruiting
Last update:2020-08-05, 1399/05/15
Update count:0
Registration date
2020-08-05, 1399/05/15
Registrant information
Name
Ali Razaghpoor
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3357 8340
Email address
alirazaghpooor@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-20, 1398/12/01
Expected recruitment end date
2020-08-20, 1399/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between the effect of Aleo Vera and Olive Oil preventive dressing usage on pressure injury development in critically ill patients who admitted to intensive care unit (ICU) of Velayat Teaching Hospital, Qazvin.
Public title
The effect of Aleo Vera and Olive Oil preventive dressing usage on pressure injury development.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
The patient or his/her family's informed consent to participate in the study.
Aged above 18 years old.
The absence of pressure injury on arrival at ICU.
Patients with moderate to high risk based on the score they achieved from the Braden criterion at entry (score 14 and below).
Exclusion criteria:
Pressure injury development within the first 12 hours after entering the ward.
Conditions where the patient's position cannot be changed, such as patients with spinal cord injury.
Drug sensitivity to Aleo Vera in group 1 and Olive oil in group 2 (according to patient or if sensitivity was observed in the study).
Patient's death
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, eligible patients will be divided into three groups by non-random sampling method using balls and bag method: 1. Aloe vera group, 2. Olive oil group, and 3. Control group. This process will be performed by a ward nurse who is unaware of the research.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Qazvin University of Medical Sciences
Street address
Qazvin University of Medical Sciences; Shahid Bahonar Boulevard; Qazvin.
City
Qazvin
Province
Qazvin
Postal code
3419915315
Approval date
2019-09-01, 1398/06/10
Ethics committee reference number
IR.QUMS.REC.1398.109
Health conditions studied
1
Description of health condition studied
Pressure injury
ICD-10 code
L89
ICD-10 code description
Pressure ulcer
Primary outcomes
1
Description
Pressure injury
Timepoint
Twice, everyday for 7 day
Method of measurement
Pressure injury staging system
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The patients' skin is examined twice a day for 7 days and the sacrum area will be bandaged using an aloe vera gel preventive dressing. Regarding the dressing and the amount and percentage of the mentioned substances, it should be noted that the amount and percentage of the substance used is determined according to the recommendation of the manufacturer and the opinion of the pharmacologist, and the size of the gases is determined according to the opinion of the pharmacologist; Thus, the preventive dressing consists of a simple gas measuring 5 cm2 impregnated with 5 cc of aloe vera, which will be used in the anatomical region of the sacrum to prevent pressure injury. It should be noted that pure aloe vera gel (100%) will be supplied by Siegol company
Category
Treatment - Other
2
Description
Intervention group: The patients' skin is examined twice a day for 7 days and the sacrum area will be bandaged using an olive oil preventive dressing. Regarding the dressing and the amount and percentage of the mentioned substances, it should be noted that the amount and percentage of the substance used is determined according to the recommendation of the manufacturer and the opinion of the pharmacologist, and the size of the gases is determined according to the opinion of the pharmacologist; Thus, the preventive dressing consists of a simple gas measuring 5 cm2 impregnated with 5 cc of olive oil, which will be used in the anatomical region of the sacrum to prevent pressure injury. It should be noted that pure olive oil (100%) will be supplied by Bahar company
Category
Treatment - Other
3
Description
Control group: Patients' skin will be examined twice a day for 7 days, using a preventative dressing without any special substance.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Velayat Hospital
Full name of responsible person
Ali Razaghpoor
Street address
Khorramshahr Blv., Valiasr Section
City
Qazvin
Province
Qazvin
Postal code
3416636175
Phone
+98 28 3357 8340
Email
alirazaghpooor@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Mohammad Mehdi Emamjomeh
Street address
Qazvin University of Medical Sciences, ُShahid Beheshti Blv.
City
Qazvin
Province
Qazvin
Postal code
3419759811
Phone
+98 28 3333 7006
Email
memamjomeh@qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Farnoosh Rashvand
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Qazvin University of Medical Sciences, Shahid Bahonar blvd.
City
Qazvin
Province
Qazvin
Postal code
3419759811
Phone
+98 912 118 3026
Email
n.rashvand@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Farnoosh Rashvand
Position
T
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Qazvin University of Medical Sciences, Shahid Bahonar blvd.
City
Qazvin
Province
Qazvin
Postal code
-
Phone
+98 912 118 3026
Email
f.rashvand@qums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Ali Razaghpoor
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Qazvin University of Medical Sciences, Shahid Bahonar blvd.
City
Qazvin
Province
Qazvin
Postal code
3416636175
Phone
+98 28 3357 8340
Email
alirazaghpooor@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
SPSS file that includes raw data without participants identitty information
When the data will become available and for how long
after article publishing to one year after this
To whom data/document is available
medical science reserchers
Under which criteria data/document could be used
scientific
From where data/document is obtainable
correspondence author
What processes are involved for a request to access data/document