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Protocol summary
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Study aim
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To assess the effect of Aloe vera gel versus control group the severity of pain and improvement of lower limb ulcers in non-diabetic patients undergoing open-heart surgery
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Design
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This is a single-blind randomized clinical trial, phase II, in which the right and left sides of 35 eligible patients will be randomly assigned to the intervention and control groups
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Settings and conduct
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The eligible diabetic patients undergoing open-heart surgery referring to the Chamran Hospital in Isfahan city during the study period will be enrolled in the trial and right and left sides of patients will be randomly assigned to the intervention and control groups through the drawing of lots. This trial will be single-blinded so that the physician examining the patients will not be aware of the intervention.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
Age of 18 to 80 years,
Open heart surgery,
Preparing graft from saphenous veins on both legs,
Exclusion criteria:
Emergency open-heart surgery,
Diabetes,
Skin disease,
Vascular disease,
Sensitivity to Aloe vera,
Chronic renal disease,
Wound infection
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Intervention groups
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Intervention group:
The surgical wound washing with normal saline and rubbing Aloe Vera gel and sterile dressing once a day for 5 days.
Control group:
The surgical wound washing with normal saline and sterile dressing once a day for 5 days.
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Main outcome variables
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The severity of surgical wound pain; the improvement of surgical wound
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20120215009014N364
Registration date:
2020-08-13, 1399/05/23
Registration timing:
retrospective
Last update:
2020-08-15, 1399/05/25
Update count:
1
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Registration date
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2020-08-13, 1399/05/23
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-09-06, 1398/06/15
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Expected recruitment end date
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2019-12-06, 1398/09/15
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Effect of Aloe Vera gel versus control group the severity of pain and improvement of lower limb ulcers in non-diabetic patients undergoing open-heart surgery: a single-blind randomized clinical trial
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Public title
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Effect of Aloe Vera gel versus control group the severity of pain and improvement of lower limb ulcers in non-diabetic patients undergoing open-heart surgery
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Age range 18 to 80 years old
Open heart surgery
Preparing graft from saphenous veins on both legs
Exclusion criteria:
Emergency open heart surgery,
Diabetes,
Skin disease,
Vascular disease,
Sensitivity to Aloevera,
Chronic renal disease,
Wound infection
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Age
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From 18 years old to 80 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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Sample size
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Target sample size:
35
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Random assignment of the right and left sides of the patients to the intervention and control groups through the drawing of lots. To do this, we prepare two sheets and write "right" on one sheet and "left" on another. Then, by referring to every patient, one of the sheets will be randomly taken. According to whether the sheet is taken right or left is assigned to the intervention group and the other side to the control group.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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The physician who will examine the patients will not be aware of the intervention. Thus, the trial will be run as single-blind
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-12-06, 1397/09/15
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Ethics committee reference number
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IR.MUI.RESEARCH.REC.1397.452
Health conditions studied
1
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Description of health condition studied
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Surgical wound of saphenous veins
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ICD-10 code
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S75.2
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ICD-10 code description
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Injury of greater saphenous vein at hip and thigh level
Primary outcomes
1
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Description
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The severity of surgical wound pain
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Timepoint
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On the first, forth, seventh, and fourteenth days
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Method of measurement
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Using Visual Analog Scale (VAS)
2
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Description
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The improvement of surgical wound
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Timepoint
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On the first, forth, seventh, and fourteenth days
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Method of measurement
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Using Reeda Scoring tool
Intervention groups
1
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Description
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Intervention group: The surgical wound washing with normal saline and rubbing Aloe Vera gel and sterile dressing once a day for 5 days.
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Category
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Treatment - Drugs
2
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Description
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Control group: The surgical wound washing with normal saline and sterile dressing once a day for 5 days.
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Category
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Treatment - Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Esfahan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available