Assessment the effect of The Heel Protective Device on the incidence and severity of pressure ulcer in elderly hospitalized patients with lower limbs fracture
Determining the effect of using heel support device on reducing the incidence and severity of pressure ulcers in the elderly with a lower limb fracture
Design
Clinical trials with a control group, non - blindness, randomized in Permuted block method
Settings and conduct
the research community of the elderly is a way of lower organ fracture, which is in the orthopedic parts of the Kamyab hospital. After selecting the Individuals who have entrance criteria, samples will be divided randomly into two groups of intervention and control groups. The intervention group will be used by heels supporting the patient's legs and reducing the pressure applied on the heel of the leg for three days. The heel support device will be made and used during the study. In the control group, routine actions will be performed, as it will be used from a pillow or roll blanket underneath the patient's leg and will be checked on a daily basis using a checklist of skin health assessment.
Participants/Inclusion and exclusion criteria
AGE more than 60 - unilateral lower limb fracture- informed consent of participating in the study-consciousness - the lack of acute problems - the absence of acute diseases - braden scores less than 16 - lack of a sustained and traumatic brain injury in the lower limb
Intervention groups
intervention group:The mechanism made by the heel supporting the heel on the heels of the patient's legs and the reduction of pressure applied on the heel to check the incidence and severity of the pressure wound will be used for three days.
control group:Routine actions are carried out, so that it will be used for three days from a pillow or roll blanket underneath the calf's leg.
Main outcome variables
the incidence and the severity of the heel pressure ulcer
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200727048225N1
Registration date:2020-10-24, 1399/08/03
Registration timing:registered_while_recruiting
Last update:2020-10-24, 1399/08/03
Update count:0
Registration date
2020-10-24, 1399/08/03
Registrant information
Name
Saeedeh Mohammadi Saber
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3256 8674
Email address
mohammadis971@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-22, 1399/08/01
Expected recruitment end date
2021-02-19, 1399/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment the effect of The Heel Protective Device on the incidence and severity of pressure ulcer in elderly hospitalized patients with lower limbs fracture
Public title
Assessment the effect of The Heel Protective Device on the incidence of pressure ulcer
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 60 years
Unilateral lower limb fracture
informed consent to participate in research
Exclusion criteria:
cognitive problems - Absence of - - Absence of
acute diseases
Braden score more than 16
pressure and traumatic ulcer in fractured lower limb
Age
From 60 years old
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
Permuted block method
In our study, we will use the random allocation of the random - block or permutation method to ensure that exactly equal numbers of participants are entered into the category of intervention and control. Each block size can be 5, 10, 16 to 20. In this way, intervention is given to the first block and routine maintenance to the second and again the first type to a third block and so on.
The randomization benefits of the block are that the balance of the number of participants in each group is guaranteed. The number of people in each group will never exceed half the number of people per block. The disadvantages of this type of randomizations are that statistical analysis in this type of segmentation is more complex and there is also a foreseeable danger that there is no difficulty in identifying the use of the vehicle, and the results will be reliable.
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
Ethics committee of Mashhad University of Medical Sciences
Street address
Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
91388-13944
Approval date
2020-08-04, 1399/05/14
Ethics committee reference number
IR.MUMS.NURSE.REC.1399.041
Health conditions studied
1
Description of health condition studied
the heel pressure ulcer
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
the incidence of the heel pressure ulcer
Timepoint
before the intervention and for 3 days during the intervention
Method of measurement
Skin health assessment checklist (based on EPUAP pressure ulcer classification system)
2
Description
severity of the heel pressure ulcer
Timepoint
before the intervention and for 3 days during the intervention
Method of measurement
PUSH questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: in the intervention group the vehicle's supporting vehicle will be used for three days, and during this period it will be done for ten minutes for patients by caregivers or nurse. During one or two shifts the researcher will take two hours for ten minutes, ensuring that it will be reassured by either cell nurse or nurse. During the intervention of each day the pressure wound or the severity of the pressure wound in the soles of the foot and leg of the leg are examined using a check list of skin health assessment (redness, itching, and burn), as well as any allergy signs (redness, itching and burning), and change position with ease of use of the use of heels supporting heels and inclination to continue taking part in the study
Category
Prevention
2
Description
Control group: Routine actions will be performed, so that it will be used for three days from a pillow or roll blanket underneath the calf's leg.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Kamyab hospital
Full name of responsible person
Alireza mahmoudi gharaee
Street address
Fadaeeiane Eslam Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
٩١۶۶۶٣٧۴٧٧
Phone
+98 51 3859 2121
Email
skh.pr@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3838 4151
Email
tafaghodiM@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Saeedeh Mohammadi Saber
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Nakhrisi Ave,. Shahid kamyab hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9156913111
Phone
+98 51 3802 6500
Email
mohammadis971@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fatemeh Esmaelzadeh
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
University St., Doktora Crossroads, School of Nursing and Midwifery, Mashhad University of Medical Sciences
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
00981511385951
Email
esmaeilzaehf@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Saeedeh Mohammadi Saber
Position
Master Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Nakhrisi Ave.,Shahid Kamyab hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9156913111
Phone
+98 51 3802 6500
Email
mohammadis971@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Only part of the data may be shared after identifying those related to the main outcome
When the data will become available and for how long
The beginning of the access period is 6 months after the results are published.
To whom data/document is available
Access is available only for practitioners working in academic and academic institutions
Under which criteria data/document could be used
The only analyses used in the study are allowed to be delivered on the data delivered
From where data/document is obtainable
mohammadis971@mums.ac.ir
What processes are involved for a request to access data/document
The data will be contacted by e - mail, and the relevant demand for e - mail is called the request and call number