Determining the effect of pistachio shell cream on the healing process of grade one pressure ulcers in patients admitted to Ali Ebn Abitaleb Hospital.
Design
A clinical trial with a control group, a parallel groups study with randomized minimization.
Settings and conduct
The research community in this clinical trial is the patients admitted to the intensive care unit of Ali Ebn Abitaleb Hospital of Rafsanjan. Patients who remain within the inclusion criteria are randomized into two groups. Pistachio cream and physiological serum are used to wash the wound in the participants of the intervention and control groups, respectively
Participants/Inclusion and exclusion criteria
All patients with stage one pressure ulcers were admitted to the ICU of Ali bin Abi Talib Rafsanjan Hospital in 2023.
Non-entry conditions:
People who have pressure ulcers of the second degree or higher
Intervention groups
Intervention group:Daily for seven days, after changing the body position and washing the wound with physiological serum, pistachio skin extract is applied with a thickness of (2-3) mm for intervention group participants. For control group participants, routine care includes changing the body position every 2-3 hours and daily washing the wound with physiological serum, is done.
Main outcome variables
Size of pressure wounds
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211128053199N2
Registration date:2023-08-25, 1402/06/03
Registration timing:registered_while_recruiting
Last update:2023-08-25, 1402/06/03
Update count:0
Registration date
2023-08-25, 1402/06/03
Registrant information
Name
Mahin Ghiyasi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3418 2587
Email address
mahinghiyasi.nurse@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-04, 1402/02/14
Expected recruitment end date
2024-05-03, 1403/02/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of pistachio cream on grade one pressure ulcers in patients admitted to Ali Ebn Abitaleb Hospital.
Public title
The effect of pistachio cream on grade one pressure ulcers in hospitalized patients.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Immobile patients
Moderate to severe loss of consciousness ( Glasgow Coma Scale<8)
Not having diabetes (based on the patient's medical history)
Absence of skin disorders such as dermatitis
Not taking corticosteroid drugs
Exclusion criteria:
Patients who have second degree pressure and higher
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
35
Randomization (investigator's opinion)
Randomized
Randomization description
Participants of the intervention and control groups are first selected among the intensive care unit patients with grade one pressure ulcers, using the convenience sampling method with the sample size of 35 participants. Then they are classified based on body mass index, (BMI ≤25 and BMI>25) and age (20-40 years, 41-60 years, 61-90 years). The first participant is randomized in the intervention or control group. Next participants enter the group with lower total BMI.
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
Rafsanjan University of Medical Sciences (RUMS)
Street address
Emam Ali Blvd,Rafsanjan City
City
Rafsanjan
Province
Kerman
Postal code
7718796755
Approval date
2022-04-12, 1401/01/23
Ethics committee reference number
IR.RUMS.REC.1401.008
Health conditions studied
1
Description of health condition studied
Pressure Ulcer
ICD-10 code
L89
ICD-10 code description
Pressure ulcer
Primary outcomes
1
Description
Type 1 pressure ulcer
Timepoint
In both groups, three days after the intervention and one week later
Method of measurement
Wound healing process using the PUSH scale(PUSH) Pressure Ulcer Scale for Healing
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: To measure the size of the wound, the largest longitudinal and transverse diameter of the wound (using a caliper with an accuracy of one millimeter) is measured and multiplied together, and the size of the wound is recorded in square centimeters. The amount of wound secretions with the factors score zero: no exudation, score one: low exudation (the sterile gauze was not wet), score two: moderate exudation (one sterile gauze was wet) and score three: high exudation (2 gauzes were wet). And the degree of tissue improvement based on the first degree: epithelial tissue, second degree: granular tissue, third degree: progenitor tissue, and the fourth degree of necrotic tissue. The highest score in Posh system is 17 and the lowest score is 3. Lower scores indicate low severity and higher scores indicate greater severity of the wound. Then, the recorded size is scored based on the PUSH scale and considering that the first stage pressure ulcer has no exudate and tissue disorder, these two items are assigned a score of zero. Each time the scores are compared and the healing process of the wound is determined based on it, and after allocating people to groups, the intervention will be implemented by the main researcher. The green and fresh skin of the ripe Uhdi pistachio variety is separated by hand and dried in the shade and at room temperature. Then the dried skin is ground and turned into powder. Finally, 150 grams of this powder is soaked in 600 ml of hydroethanolic solution for 96 hours at room temperature. After filtering with a cloth and then Whatman No. 1 filter paper, the extract solution under the filter is dried in an oven at a temperature of 40 °C. The obtained dry extract is kept at -20°C until consumption. It should be mentioned that the formulation is done in clean conditions by Barij Essans Daru Company in Kashan. In the intervention group, daily and for seven days after changing the position and washing the wound with physiological serum, pistachio skin extract with a thickness of (2-3) mm was applied to the wound using a sterile abslang and covered with a sterile gauze. can be In order to ensure that the patient is not allergic to pistachio skin extract, before the intervention, a layer of this extract will be rubbed on the inner part of the patient's arm and the patient's reaction will be checked within 30 minutes after use.
Category
Prevention
2
Description
Control group: In the control group, routine care includes changing the position every 2-3 hours and washing with physiological serum daily.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali ibn Abi Talib Hospital
Full name of responsible person
Ali Nakhei
Street address
Emam Ali Blvd.
City
Rafsanjan
Province
Kerman
Postal code
7718796755
Phone
+98 34 3428 0000
Email
alinakhei77@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Reza Vaziri
Street address
Emam Ali Blvd
City
Rafsanjan
Province
Kerman
Postal code
7718796755
Phone
+98 34 3428 0041
Email
rvazirinejad@yahoo.co.uk
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
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
Mahin Ghiyasi
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Parastar Blvd
City
Rafsanjan
Province
Kerman
Postal code
7718796755
Phone
+98 34 3428 0000
Email
mahinghiyasi.nurse@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Fateme khoshoei
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Parastar Blvd
City
Rafasanjan
Province
Kerman
Postal code
7718796755
Phone
+98 34 3428 0000
Email
fatemekhoshoei8@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Heidarzadeh Azam
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Parastar Blvd
City
Rafsanjan
Province
Kerman
Postal code
7718796755
Phone
+98 34 3428 0000
Email
heidarzadehazam@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Only a part of the data, such as the information related to the main result or the like, can be shared.
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
It will be available for researchers working in academic and scientific institutions, or people who are also working in industry can apply for them.
Under which criteria data/document could be used
It will be available for researchers working in academic and scientific institutions, or people who are also working in the industry can apply for them.
From where data/document is obtainable
For information, people can contact the responsible author by calling 09103131606 and by e-mail at mahinghiyasi.nurse@gmail.com and at the address of Rafsanjan, Nurse Street, Nursing School.
What processes are involved for a request to access data/document
Whenever a person requests information, she can communicate with the email and contact number, and she will receive the information after 24 hours.