evaluation effects of Aloe vera gel versus conventional dressing on the healing rate and pain of second degree pressure ulcer
Design
In this study, the units were selected from the study population by convenience sampling or available sampling method and then randomly divided into two experimental groups. The two groups were matched in terms of wound size, wound depth, absence of underlying disease and wound location. The first group or the experimental group was treated with aloe vera gel. In this way, after washing the wound daily with normal saline, a layer of aloe vera gel with a diameter of 5 mm was placed on the wound and covered with two or three layers of sterile gauze and bandaged on the wound with a sterile bandage.
The second group or the control group was treated with normal saline, so that this group was covered with two or three layers of sterile gas daily after washing the wound with normal saline and bandaged on the wound with a sterile bandage.
Settings and conduct
This clinical trial will be carried out at Imam Khomeini Hospital of Shahkhamin Hospital and Valiasr Hospital in Arak,
Participants/Inclusion and exclusion criteria
Participants had grade 2 pressure ulcers.
The patient's wound was not contaminated.
Not all subjects had symptomatic infections in different parts of the body before entering the study. They were willing to participate in the research and were able to answer the questions
If patients withdrew from treatment after admission to the study or if any allergies and drug sensitivities to the treatment occurred, patients were excluded from the study.
Intervention groups
all patients with stage 2 pressure ulcer who sign the inform consent
Main outcome variables
|Healing rate, pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180715040478N2
Registration date:2021-08-17, 1400/05/26
Registration timing:retrospective
Last update:2021-08-17, 1400/05/26
Update count:0
Registration date
2021-08-17, 1400/05/26
Registrant information
Name
Azam Malekhoseini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3505
Email address
Azam.malekhoseini@khomeinums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-08, 1398/10/18
Expected recruitment end date
2021-02-08, 1399/11/20
Actual recruitment start date
2020-01-08, 1398/10/18
Actual recruitment end date
2021-02-08, 1399/11/20
Trial completion date
2021-02-08, 1399/11/20
Scientific title
Comparison of the Effectiveness of Aloe Vera Gel and Conventional Dressing on Wound Healing and pain of Second Grade Bed sore .
Public title
The Effect of Aloe Vera Gel in Bed sore .
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Participants have grade 2 pressure ulcer
The patient's wound should not be contaminated with contaminants
Before entering the study did not use any substance other than drinking water on the wound
Participants should not have symptomatic infections of different parts of the body before entering the study
Willingness to participate in research
Be able to answer questions
Exclusion criteria:
Unwillingness of patients or their families to participate in the study.
Age
From 18 years old to 100 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
56
Actual sample size reached:
64
Randomization (investigator's opinion)
Randomized
Randomization description
The samples were selected from the study population by Simple randomization or available sampling method (coin tossing) were placed in each group of ten people, after which the background characteristics of patients in each group were evaluated. The next patient to enter the study was admitted to a group that minimized the overall difference between the groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
Randomized double- blind (Patients and assessor)
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Khomein University of Medical Sciences
Street address
Azadi Street
City
Khomein
Province
Markazi
Postal code
38818-58573
Approval date
2019-05-28, 1398/03/07
Ethics committee reference number
IR.KHOMEIN.REC.1398.007
Health conditions studied
1
Description of health condition studied
bed sore
ICD-10 code
L89
ICD-10 code description
Decubitus ulcer and pressure area
Primary outcomes
1
Description
size of wound
Timepoint
The first, seventh and fourteenth day
Method of measurement
Using tape measure
2
Description
The amount of pain
Timepoint
The first, seventh and fourteenth day
Method of measurement
Visual Analogue Scale of Pain
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Normal saline group
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Vali-Asr Hospital of Arak
Full name of responsible person
ََAzam malekhoseini
Street address
Arak, Imam Khomeini St., Vali Asr Square
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Email
pr_valieasr@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Azam malekhoseini
Street address
Arak, Ayatollah Ghaffari St., intersection of Vali Asr St.
City
Arak
Province
Markazi
Postal code
3817834467
Phone
+98 86 3226 7892
Email
malekhoseni.aram@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Azam malekhoseini
Position
Coach
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Arak: Sardasht - Basij Square - Academic Complex of the Great Prophet (PBUH) - Facilities
City
Arak
Province
Markazi
Postal code
38481-7-6341
Phone
+98 86 3417 3520
Email
malekhoseni.aram@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Azam malekhoseini
Position
Coach
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Arak: Sardasht - Basij Square - Academic Complex of the Great Prophet (PBUH) - Facilities
City
Arak
Province
Markazi
Postal code
38481-7-6341
Phone
+98 86 3417 3520
Email
malekhoseni.aram@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Azam malekhosini
Position
Coach
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Arak: Sardasht - Basij Square - Academic Complex of the Great Prophet (PBUH) - Facilities
City
Arak
Province
Markazi
Postal code
38481-7-6341
Phone
+98 86 3417 3520
Email
malekhoseni.aram@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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available