The effect of follow-up prevention or these of heel pressure ulcer, drop foot, and pelvic rotation in patients coma or low alertness intensive care unit (ICU) Semnan kowsar hospital
The effect of follow-up prevention or these of heel pressure ulcer, drop foot, and pelvic rotation in patients coma or low alertness intensive care unit (ICU) Semnan kowsar hospital
Design
Clinical trials with control group, with parallel groups, randomized, without control with placebo, single center trial. Sample size was 60 patients (2 groups of 30 control and intervention).
Settings and conduct
Kowsar hospital's intensive care unit in Semnan.
Heel pressure ulcer orthoses are used for 30 patient (Unconscious or with low alertness) admitted to the intensive care unit of Kowsar Hospital in Semnan for 7 days.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients 20-70 years old; Patients with Diabetic Heel Wounds; Patients with heel soft tissue injuries.
Exclusion criteria: Patient dissatisfaction.
Intervention groups
Control group: Only for comparison with intervention group, no treatment is performed.
Intervention group: Heel pressure ulcer orthoses are used for patients (Unconscious or with low alertness) admitted to the intensive care unit of Kowsar Hospital in Semnan for 7 days.
Main outcome variables
Degree of hip rotation; Heel pressure ulcers.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151228025732N45
Registration date:2019-11-10, 1398/08/19
Registration timing:registered_while_recruiting
Last update:2019-11-10, 1398/08/19
Update count:0
Registration date
2019-11-10, 1398/08/19
Registrant information
Name
Alireza Emadi
Name of organization / entity
Semnan University of Medical Sciences, Semnan, Iran
Country
Iran (Islamic Republic of)
Phone
+98 23 3345 1336
Email address
are20935@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-16, 1398/04/25
Expected recruitment end date
2020-07-15, 1399/04/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of follow-up prevention or these of heel pressure ulcer, drop foot, and pelvic rotation in patients coma or low alertness intensive care unit (ICU) Semnan kowsar hospital
Public title
The effect of follow-up prevention or these of heel pressure ulcer, drop foot, and pelvic rotation in patients coma or low alertness intensive care unit (ICU) Semnan kowsar hospital
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients 20-70 years old
Patients with Diabetic Heel Wounds
Patients with heel soft tissue injuries
Exclusion criteria:
Patient dissatisfaction
Age
From 20 years old to 70 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
Patients are allocated randomly with simple sequential allocation in one of the two study groups by help of sealed envelope and receive the intervention of the same group. The unit of randomization will be the referred patient. Sealed envelopes will be delivered to expert. With each patient's visit, one of the envelopes will be randomly selected by the patients and will be introduced as a study group. The stratification approach is not used.
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 Semnan University of Medical Sciences
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Approval date
2019-07-16, 1398/04/25
Ethics committee reference number
IR.SEMUMS.REC.1398.103
Health conditions studied
1
Description of health condition studied
heel pressure ulcer
ICD-10 code
S91.0
ICD-10 code description
Open wound of ankle
Primary outcomes
1
Description
Degree of hip rotation
Timepoint
Before and after the intervention
Method of measurement
Goniometer
2
Description
Heel pressure ulcers
Timepoint
Before and after the intervention
Method of measurement
By software
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Only for comparison with intervention group, no treatment is performed.
Category
N/A
2
Description
Intervention group: Heel pressure ulcer orthoses are used for patients (Unconscious or with low alertness) admitted to the intensive care unit of Kowsar Hospital in Semnan for 7 days.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Kowsar Hospital
Full name of responsible person
Shahrukh Khojastehfar
Street address
Amin Street , Semnan
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3345 1336
Email
are20935@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Parviz Kokhaei
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan.
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
P_kokha@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Shahrukh Khojastehfar
Position
Nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Amin Street , Semnan
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3345 1336
Email
are20935@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Shahrukh Khojastehfar
Position
Nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Amin Street , Semnan
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3345 1336
Email
are20935@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Shahrukh Khojastehfar
Position
Nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Amin Street , Semnan
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3345 1336
Email
are20935@gmail.com
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