This study intents to study Aloe Vera gel in the prevention of pressure ulcers in patients hospitalized in the orthopedic ward. This research is a random triple-blind clinical trial that patients, researchers and analysts aren't informed of the intervention and control groups. After obtaining informed consent, 80 patients admitted in the orthopedic ward because of fracture and immobility and having the specifications of taking part in the research are selected based on purposive sampling. They are divided in two groups by Random Allocation. Both groups will be examined after patient reception using Braden tool and those who score less than 14 (they are at risk of moderate to severe bed sores) are enrolled. In both groups, the daily care will be done by nurses to prevent bed ulcers for patients. The researcher moisturizes the same areas in the test group as moisturized in the control group by an applicator.
Furthermore, in the intervention group after checking the absence of an allergic reaction, pure Aloe Vera gel is applied twice a day (at 9a.m and 9 p.m) on the areas of hip, sacrum and heel. In the control group the researcher moisturizes the same areas by placebo (gel, water and starch) using an applicator and removes the material from the skin by a tissue. Sacrum, hip and heel are controlled on days 3, 7 and 10 in terms of presence or absence of symptoms of pressure ulcers based on the scale of pressure ulcers and scale of Braden risk of pressure ulcer
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016051027825N1
Registration date:2016-09-07, 1395/06/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-09-07, 1395/06/17
Registrant information
Name
Fatemeh Mehrabi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3457 5029
Email address
f.mehrabi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences
Expected recruitment start date
2016-06-25, 1395/04/05
Expected recruitment end date
2016-09-26, 1395/07/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Aloe Vera gel on prevention of pressure sore among patients hospitalized in orthopedic ward
Public title
Effect of Aloe Vera gel on prevention of pressure sore among patients hospitalized in orthopedic ward
Purpose
Prevention
Inclusion/Exclusion criteria
The inclusion criteria will be: Lack of skin diseases (like psoriasis, fungal diseases; Vitiligo); patients over 18 years and below 65; patients diagnosed by a nurse as a ‘risk for impaired skin integrity’, by applying the Braden Scale for prediction of pressure ulcer risk showing a high risk or moderated risk (score under14); willingness to participate in the research; not having pressure ulcers; possibility of Continuity of orthopedics ward hospitalization ;being receptioned more than 24 hours in orthopedic ward and not being already admitted in another part; The lack of systemic disease, diabet, Bleeding from injury, heart failer, renal failer and advanced phase of cancer; Having a systolic blood pressure of 10 mm Hg or higher; not receiving vasoactive drugs; lack of drug addiction; temperature under 38.8; hemoglobin upper than 12.
Exclusion criteria: The patient declining to take part in research; the patient death; hemoglobin reduction level during the study in men below 12 and in women below 10 mg /dl; receiving vasoactive drugs; anemia,hypotention, hyperthermia during the study.
Age
From 77 years old to 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of the Arak University of Medical Sciences
Street address
Floor 3; Bldg Emam Mosaa Kazem; University of Medical Sciences Complex; Sq Basij; Sardasht
City
Arak
Postal code
3848176941
Approval date
2016-05-23, 1395/03/03
Ethics committee reference number
IR.ARAKMU.REC.1395.40
Health conditions studied
1
Description of health condition studied
Pressure Ulser
ICD-10 code
L89
ICD-10 code description
Decubitus ulcer and pressure area
Primary outcomes
1
Description
The incidence of pressure ulcers
Timepoint
The third day, seventh, tenth after intervention
Method of measurement
check list of daily erythema, temperature, edema and pain
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group :At first some pure Aloe Vera gel is tested on Inside of the forearm and in the absence of an allergic reaction, at a later stage pure Aloe Vera gel is applied twice a day (at 9a.m and 9 p.m) on the pressure areas (hip, sacrum and heel) for 10 days. And we wait for 2-1 minutes to have the gel absorbed. Under study areas are controlled on days 3, 7 and 10 in terms of presence or absence of symptoms of pressure ulcers based on the index means of pressure ulcers and scale of Braden risk of pressure ulcer.
Category
Prevention
2
Description
control group: the researcher moisturizes the same areas by placebo (gel, water and starch) using an applicator and removes the material from the skin by a tissue. Sacrum, hip and heel are controlled on days 3, 7 and 10 in terms of presence or absence of symptoms of pressure ulcers based on the scale of pressure ulcers and scale of Braden risk of pressure ulcer.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Vali-Asr Hospital of Arak
Full name of responsible person
Fatemeh Mehrabi
Street address
School of Nursing and Midwifery; University Complex Payambar Azam; Sq Basij; Sardasht
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Vice chancellor for research, Arak University of Medical Sciences
Street address
Floor 3; Bldg Emam Mosaa Kazem; University of Medical Sciences Complex; Sq Basij; Sardasht
City
Arak
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
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Fatemeh Mehrabi
Position
MSc Student of Medical Surgical Nursing
Other areas of specialty/work
Street address
School of Nursing and Midwifery; University Complex Payambar Azam; Sq Basij; Sardasht.
City
Arak
Postal code
3848176941
Phone
+98 86 3417 3503
Fax
Email
fmehrabi1392@gmail.com; f.mehrabi@arak.mu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Davud Hekmat Pou
Position
Associate Professor
Other areas of specialty/work
Street address
School of Nursing and Midwifery; University Complex Payambar Azam; Sq Basij; Sardasht.
City
Arak
Postal code
3848176941
Phone
+98 86 3417 3503
Fax
Email
hekmatpou@yahoo .com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Fatemeh Mehrabi
Position
MSc Student Of Medical Surgical Nursing
Other areas of specialty/work
Street address
School of Nursing and Midwifery; University Complex Payambar Azam; Sq Basij; Sardasht