Investigating the effect of Rosemary topical ointment on bedsore grade I in hospitalized patient in ICU of Ali-ebn- abitalib hospital; 2018
Design
Clinical trial with control group, Community based and pragmatic, with parallel groups, blinded postoperative care, randomized
Settings and conduct
In this study, the effect of rosemary ointment on the size of the patient's pressure ulcer in the intensive care unit was investigated. In this study, the evaluator did not know how to grouping.
Participants/Inclusion and exclusion criteria
Age over 20 years
Lack of diabetes
No use of corticosteroids
Patients are motionless
Patients have moderate to severe decrease levels of consciousness
Intervention groups
Intervention group: Application of rosemary ointment
Control group: No application of Rosemary ointment
Main outcome variables
pressure ulcer size
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160503027736N3
Registration date:2018-06-10, 1397/03/20
Registration timing:prospective
Last update:2018-06-10, 1397/03/20
Update count:0
Registration date
2018-06-10, 1397/03/20
Registrant information
Name
shahin heidari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3428 5351
Email address
sh.heidari@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2019-03-20, 1397/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effectiveness of Rosemary ointment on Improving of pressure ulcer stage 1 in hospitalized patient of Intensive care unit
Public title
Investigating the effect of Rosemary ointment on bedsore grade 1
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 40 years
The absence of skin disorders such as dermatitis
Moderate and severe alertness
Exclusion criteria:
ِDischarge with personal consent
Failure to cooperate for any reason during the study
Progress towards pressure ulcer stage 2
Age
From 20 years old to 90 years old
Gender
Both
Phase
0
Groups that have been masked
Participant
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
The intervention group was recruited from the patients admitted to the intensive care unit with pressure ulcer stage I, in a sample size (n=35) in convenience method. Then, they will be classified according to the Body mass index (equal and less than 25 and above 25) and the age (20-40 years, 41-60 years, 61-90 years). The control group according to the Body mass index and age classification of the intervention group, was selected from among the patients admitted to the intensive care unit with the pressure ulcer stage I with convenience method.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the evaluator of bed sore size is not aware of patient grouping.
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethics committee in medical researches
Street address
Imam Ali
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Approval date
2017-12-21, 1396/09/30
Ethics committee reference number
IR.RUMS.REC.1396.208
Health conditions studied
1
Description of health condition studied
Bed sore
ICD-10 code
L89
ICD-10 code description
Pressure ulcer
Primary outcomes
1
Description
Ulcer area
Timepoint
Everyday until 7 days
Method of measurement
Ruller
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this study, the length and width of the pressure ulcer will be measured first by the ruler. Then, the wound is wiped with 100 cc normal saline solution, 0.9% sterile non-injectable. After drying with sterilized gauze, the Rosemary ointment 30 grams made by Iranian GOLDARU Company (Isfahan, Iran), with a thickness of 2-3 mm, is placed on a 8-layer sterile gauze. Then, the ointment impregnated gauze is placed on a pressure ulcer and glued to the healthy skin with a paper anti-allergenic adhesive. This process takes place once a day for 7 days. On the third and seventh day after the application of the ointment, the extent of the wound will be measured with the same ruler. The size of the wound will be classified using the pressure ulcer scale for healing tool (PUSH) from 0 to 10. Zero means no wound, and number 10 means a wound with more than 24 Square centimeters. Finally, the three scores of different stages of measurement, will be compared.
Category
Treatment - Drugs
2
Description
Control group: In this study, rosemary topical ointment will not be used for any control group, and they will receive routine cares.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
بیمارستان علی ابن ابیطالب
Full name of responsible person
Fatemeh Khoshoei
Street address
Imam Ali
City
Rafsanjan
Province
Kerman
Postal code
7717937555
Phone
+98 34 3428 0000
Email
fatemehkhoshoei8@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Ali Shamsi
Street address
Imam Ali
City
Rafsanjan
Province
Kerman
Postal code
7711177111
Phone
+98 34 3428 0038
Email
alishamsy@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan 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
Rafsanjan University of Medical Sciences
Full name of responsible person
Heidari Shahin(PHD)
Position
PHD of nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing college of Rafsanjan
City
Rafsanjan
Province
Kerman
Postal code
7718796755
Phone
+98 34 3824 7537
Fax
Email
sh.heidari@rums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Heidari Shahin(PHD)
Position
PHD of Nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Rafsanjan School of Nursing
City
Rafsanjan
Province
Kerman
Postal code
7718796755
Phone
+98 34 3824 7537
Fax
Email
sh.heidari@rums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Heidari Shahin(PHD)
Position
PHD of nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Rafsanjan School of Nursing
City
Rafsanjan
Province
Kerman
Postal code
7718796755
Phone
+98 34 3824 7537
Fax
Email
sh.heidari@rums.ac.ir
Web page address
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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is 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
Title and more details about the data/document
Age, Gender, hemoglobin, haematocrit, and the main outcome can be expressed
When the data will become available and for how long
2019
To whom data/document is available
Universities researchers
Under which criteria data/document could be used
For research, by submitting a valid academic Demand
From where data/document is obtainable
Vice chancellor for research & technology
What processes are involved for a request to access data/document
Submitting a written request to the Rafsanjan University of medical sciences, Vice chancellor for research, agreeing to study colleagues