Determination of the effect of preventive dressing of Aloe vera and honey gel on the incidence of compression wound in patients admitted to the intensive care unit (ICU) of Qazvin vellayat hospital
Design
This study is a clinical trial with parallel groups. 30 samples in each group are included in the study. Considering the fact that we have three groups, 90 samples are being studied. Randomization: 90 balls are placed inside the bag, and the ball is numbered up to 30 first groups, 31 to 60 second group and 61-90 third group. With the arrival of each patient, an orb is pulled out and the patient is placed in the target group and the ball is pulled out of the bag.
Settings and conduct
For 7 days, twice a day, the patient is washed with normal saline in the sacrum area. Then, in the first group, the Aloe vera gel is used in the second group of honey, and in the third group the is used simple dressing gauze. We will not be blind in this study
Participants/Inclusion and exclusion criteria
Inclusion criteria: No pressure ulcer at the time of arrival of the patient to ICU,
2. Medium and high risk patients, based on the score that Bradan scored when entering the ICU section.3. Age over 60 years old
exclusion criteria:
1. Absolute movement limits
Intervention groups
Intervention group: Use of Aloe vera gel in sacrum area and application of honey in sacrum area. Control group: Traditional sterile gas dressing
Main outcome variables
The rate of the patient's exposure to pressure injury
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190326043114N1
Registration date:2019-11-09, 1398/08/18
Registration timing:retrospective
Last update:2019-11-09, 1398/08/18
Update count:0
Registration date
2019-11-09, 1398/08/18
Registrant information
Name
Amirhosein farzami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3377 9639
Email address
amirhoseinfarzami@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-03, 1398/01/14
Expected recruitment end date
2019-07-23, 1398/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between effect of aloe vera and honey prophylactic dressings on the incidence of pressure injury among Elderly Patients
Public title
effect of aloe vera and honey prophylactic dressings on the incidence of pressure injury
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
not having pressure ulcer at the time of admission to the ICU
Patients with a high and medium risk score based on the Braden criterion at the start of the ICU (Score Bradden adjusted to 14 and lower).
Age over 60 years old
Exclusion criteria:
There is an absolute motion limitation requested by the physician and prevents the patient from moving.
Age
From 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
for random allocation in this study will be use Bowl and individual methods It will be placed 90 small beads in a non-transparent container On the beads, the number will be one to 90 labels.
The numbers 1 to 30 belong to the AloeVera group and the numbers 31 to 60 belong to the honey group and the numbers 61 to 90 belong to the placebo group.
After each patient is admitted to the intensive care unit, a bead will be randomly removed from the container.
And determine which the patient will belong to, of the three groups And the nut will be removed and will not be returned to the container
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Qazvin University of Medical Sciences
Street address
Qazvin University of Medical Sciences.Qazvin. Shahid Bahonar Blvd.
City
qazvin
Province
Qazvin
Postal code
31948183111
Approval date
2019-03-12, 1397/12/21
Ethics committee reference number
IR.QUMS.REC.1397.403
Health conditions studied
1
Description of health condition studied
pressure ulcer
ICD-10 code
l89
ICD-10 code description
Decubitus ulcer and pressure area
Primary outcomes
1
Description
percentage of incidece pressure ulcer
Timepoint
Daily check up spot of medication use
Method of measurement
observation
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patient sacrum area is evaluated for 7 days, twice daily, for the onset of compression ulcers. In the absence of a pressure ulcer, the skin of the sacrum area is first washed with a normal saline solution. Then, 5 cc of the Aloe Vera gel is applied to the sacrum skin, and then a simple dressing gauze with 10 * 10 cm dimensions is placed on it and will be kept with a mattress glue on the skin.
Category
Prevention
2
Description
Intervention group 2: Sacrum area of the patient is evaluated for the duration of 7 days, twice daily, for the incidence of compression ulcers. In the absence of a pressure ulcer, the skin of the sacrum area is first washed with a normal saline solution. Then 5 cc of honey is rubbed into the skin of the sacrum area, and then a simple dressing gauze placed 10 x 10 cm in size and will be kept firmly fixed on the skin with a mattress glue.
Category
Prevention
3
Description
Control group: The skin of the sacrum area of the patient will be examined twice a day by the nurse for the occurrence of pressure ulcers twice daily for a maximum of seven days.In the absence of pressure ulcer as soon as it enters the icu unit, the skin of the sacrum area is first washed and cleaned by the researcher with normal saline solution, and a simple dressing gas of 10 x 10 cm is applied on it and glued on. It will be fixed on the skin.glued