A comparative study of the local effect of Aloe Vera gel with cold and warm compress on ecchymosis of the lower leg after coronary artery bypass surgery
Determining the local effect of aloe vera gel with hot and cold compresses on leg area hemorrhage of patients undergoing coronary artery bypass surgery
Design
A three-group controlled clinical trial with random allocation of 60 patients in phase 3, from among patients undergoing coronary artery bypass surgery and research units, with a gradual method based on the order of referrals, with random allocation (using a coin toss) in group A or group B or are controlled.
Then, the samples in each group are randomly selected to determine the right or left leg for intervention, using two envelopes containing number 1 (intervention) and number 2 (control) inside a box, and based on the desired number, the cutting place Leg surgery patients are assigned to two intervention groups with aloe vera and control. The same procedure is done in groupB
Settings and conduct
Hospitalized patients chamran are placed in group A or B based on randomization
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Informed and written consent to participate in the study
Coronary artery bypass surgery
Vascular graft removal from both legs
exclusion criteria:
history of skin disease
emergency surgery
allergic to aloe vera
using drugs or continuous use of alcohol or cigarettes
history of vascular disease such as Raynaud's, Berger's, etc
history of allergy
coagulopathy or the need to take anti-coagulant drugs
Intervention groups
Steps of doing work in the intervention group is an aloe vera gel before dressing the wound for 6 days. In intervention group two, one of the legs is placed in a cold compress in the first 48 hours after the surgery, and then in the third to sixth days of the surgery, a warm compress is applied.
In the intervention control group, routine wound cleaning and dressing are considered.
Main outcome variables
The average area of hemorrhage in A and B groups
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150715023216N16
Registration date:2023-11-06, 1402/08/15
Registration timing:registered_while_recruiting
Last update:2023-11-06, 1402/08/15
Update count:0
Registration date
2023-11-06, 1402/08/15
Registrant information
Name
Said Amini Rarani
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3522 6158
Email address
ghadami@mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-23, 1402/08/01
Expected recruitment end date
2023-12-21, 1402/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of the local effect of Aloe Vera gel with cold and warm compress on ecchymosis of the lower leg after coronary artery bypass surgery
Public title
A comparative study of the local effect of Aloe Vera gel with cold and warm compress on the lower leg after coronary artery bypass surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Informed and written consent to participate in the study
Coronary bypass surgery
removal of vascular grafts from both legs
Exclusion criteria:
history of skin disease
emergency surgery
allergy to aloe vera
drug use or continuous alcohol or cigar use
history of vascular disease such as Raynaud's, Berger's, etc.
history of drug, food or allergy
coagulopathy or the need to take anti-coagulant drugs
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The number of 60 patients who are candidates for coronary artery bypass surgery in Chamran Hospital according to the entry criteria, with a gradual method based on the order of referrals with random allocation (using a coin toss) in group A (local effect of aloe vera gel) or group B ( use of cold and warm compresses) or control are placed.
Then, the subjects in each group are randomly selected in order to determine the right or left leg for intervention, using two envelopes containing number 1 (intervention) and number 2 (control) inside a box, and based on the desired number, The surgical incision site of the patient's legs is allocated in the intervention leg with aloe vera and the control leg.
The same procedure is done for the patient in group B.
In groups A and B, one foot of the patient is treated and the other foot is considered as control.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Committee of Isfahan University of Medical Sciences
Street address
Hezarjerib street, Isfahan,Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2023-09-04, 1402/06/13
Ethics committee reference number
IR.MUI.NUREMA.REC.1402.098
Health conditions studied
1
Description of health condition studied
Ecchymosis
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Average area of Ecchymosis
Timepoint
Days 2, 5, 7, 10 and 30 after coronary artery bypass surgery
Method of measurement
The program for determining the area of j image and A30s phone camera
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The first stage of intervention in group A (local effect of aloe vera gel) is performed before dressing the wound in the operating room. In the opposite leg, routine intervention is performed, i.e. washing the wound with normal saline and dressing with sterile gauze and adhesive and bandaging. This procedure continues for 6 days. Photographs are taken of the desired position (legs of both legs) (days 2, 5, 7, 10 and 30). On the 10th and 30th days, in the office of Dr. Mohsen Mir Mohammad Sadeghi, photographs of the patient's legs are taken and the area of hemorrhage is calculated using image j software.The aloe vera gel used in this research is prepared by Reyhan Naqsh Jahan Pharmaceutical Company based on the United States Pharmacopoeia (USP), which is packed in sterile containers under sterile conditions and in compliance with hygiene precautions with sterile gloves. Intervention with aloe vera gel in The first to sixth days are done in the inpatient departments. In group A, the first intervention stage is performed in the operating room by Dr. Mohsen Mir Mohammad Sadeghi's dedicated assistant with sterile aloe vera gel that has been prepared in advance on the affected leg, and then dressing is performed with sterile gauze, glue, and bandaging. Dressing with sterile gauze, glue and bandaging is performed on the control legThen, on a daily basis, standard methods of surgical wound care, such as washing with normal saline and performing sterile dressings once a day, elastic bandages for both legs of patients, are performed by nurses working in the special care and surgery department. Both groups A and B, one leg of the patient is treated and the other leg is considered as control.
Category
Prevention
2
Description
In group B (use of hot and cold compresses), one of the legs is placed under a cold compress in the first 48 hours after the surgery, and then on the third to sixth days of the surgery, a warm compress is applied, and in the opposite leg, a routine intervention, i.e. washing the wound with Normal saline serum and dressing is done with sterile gauze and adhesive and bandaging. This procedure continues for 6 days. Photographs are taken of the desired position (legs of both legs) (days 2, 5, 7, 10 and 30). On the 10th and 30th days, in the office of Dr. Mohsen Mir Mohammad Sadeghi, photographs are taken of the patient's legs and the area of hemorrhage is calculated using image j software.Intervention with cold compresses in the inpatient wards, on the first two days of surgery, a gel pack (HEPSUN) that has been placed in the freezer an hour before is placed around the wound with a gauze cover for 10 minutes, and in the next four days in the inpatient wards ( Day 3, 4, 5, 6) A warm compress in the form of a jelly pack (HEPSUN) that we have previously placed in the microwave for one minute or in boiling water for 10 minutes, is placed in a cloth bag and placed around the wound on the control leg. Dressing is done with sterile gauze, glue and bandaging.On a daily basis, standard methods of surgical wound care, such as washing with normal saline and performing sterile dressings once a day, elastic bandages for both legs of patients are performed by nurses working in the special care and surgery department. Both groups A and B, one leg of the patient is treated and the other leg is considered as control.
Category
Prevention
3
Description
Control group: In this research, the control group is the same leg opposite to the intervention leg in intervention number 1 and 2. In both groups A and B, based on randomization, using a box, one leg of the intervention patient and the other leg It is considered as the control leg. In the control group, the routine intervention is washing the wound with normal saline and dressing with sterile gauze, glue and bandaging. This procedure continues for 6 days. Photographs are taken of the target position (legs of both legs) (days 2, 5, 7, 10 and 30) and the area of hemorrhage is calculated using image j software.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Chamran Hospital
Full name of responsible person
Ahmad Gadami
Street address
Hezarjerib Street . Isfahan .Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7583
Email
ghadami@mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ahmad Gadami
Street address
HezarJerib Street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3028
Email
ghadami@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Ahmad Gadami
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
HezarJerib Street , Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7583
Email
ghadami@mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Zahra Shahriar Panah
Position
Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
HezarJerib Street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3028
Email
kosarhasan.shahryar06@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Zahra Shahriar Panah
Position
student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
HezarJerib Street , Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3028
Email
kosarhasan.shahryar06@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
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