Comparison the effect of hydrocolloid with film dressing on prevention of pressure ulcer caused by O2 therapy equipment in patients in critical care units
Comparison the effect of hydrocolloid with film dressing on prevention of pressure ulcer caused by O2 therapy equipment in patients in critical care units
Design
Two arm parallel group randomised trial with blinded postoperative care and outcome assessment
Settings and conduct
After selecting the sample, they will randomly the right ear is used by the dressing of the hydrocolloid, and in the transparent film dressing group, the transparent film dressing will be used to cover the right ear of the patient.In both groups, the left ear is considered as control. The location of the dressing of both ears in both groups is investigated by a trained person without any knowledge of the study objective twice a day r. The intervention will continue for 3 days .
Participants/Inclusion and exclusion criteria
Having informed consent to attend research
The need for oxygen therapy for more than two hours through nasal cannula and facial mask
Age older than 18 years
The absence of ulcers in the patient's ears and having healthy ears
Cancellation of the patient, but the patient's cure at any time of the study
Discontinue oxygen therapy during the study according to the physician's order
Discharge or transfer of patient
Intervention groups
the research sample is easy and based on the goal, according to the input criteria, it will be divided into two groups of easy hydrocolloid dressing by simple random method. the right ear is considered as an intervention and the left ear is considered as control.
Main outcome variables
Comparison of the effect of two dressings on the prevention of compression caused by medical equipment due to the difference in the production of pressure ulcers caused by oxygen therapy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190320043094N1
Registration date:2019-04-01, 1398/01/12
Registration timing:prospective
Last update:2019-04-01, 1398/01/12
Update count:0
Registration date
2019-04-01, 1398/01/12
Registrant information
Name
Neda Sabahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5722 3028
Email address
nedasabahi123@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-21, 1398/02/01
Expected recruitment end date
2019-06-22, 1398/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of hydrocolloid with film dressing on prevention of pressure ulcer caused by O2 therapy equipment in patients in critical care units
Public title
Comparison the effect of hydrocolloid with film dressing on prevention of pressure ulcer caused by O2 therapy equipment in patients in critical care units
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Having informed consent to attend research
The need for oxygen therapy for more than two hours through nasal cannula and facial mask
Age older than 18 years
The absence of ulcers in the patient's ears and having healthy ears
Exclusion criteria:
Cancellation of the patient, but the patient's cure at any time of the study
Discontinue oxygen therapy during the study according to the physician's order
Discharge or transfer of patient
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In this research, the research sample was easy and based on the purpose of the selected entry criteria and then the method
Easy randomization will be divided into two groups of hydrocolloid and transparent dressing. In each group, the right ear is as an intervention
The left ear will be considered as control.
Blinding (investigator's opinion)
Double blinded
Blinding description
In the patients of the hydrocolloidal dressing group, the right ear is used by the dressing of the hydrocolloid, and in the transparent film dressing group, the transparent film dressing will be used to cover the right ear of the patient. In both groups, the left ear is considered as control. The location of the dressing of both ears in both groups is investigated by a trained person without any knowledge of the study objective twice a day and recorded in the monitoring checklist of the pressure ulcer.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethnical CommitEthnical Committee of Gonabad University of Medical Sciences
Street address
Imam Khomeini Street, Gonabad University of Medical Sciences
City
Gonabad
Province
Razavi Khorasan
Postal code
۹۶۹۱۷۹۷۸۵۲
Approval date
2019-03-26, 1398/01/06
Ethics committee reference number
IR.GMU.REC.1397.131
Health conditions studied
1
Description of health condition studied
pressure ulcer
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pressure ulcer
Timepoint
The effect of hydrocolloid dressing and film cloth will be checked for three days and twice a day.
Method of measurement
Braden Scale
Secondary outcomes
1
Description
Braden Scale
Timepoint
Before the intervention begins
Method of measurement
Braden Scale
Intervention groups
1
Description
Intervention group: Intervention group: The first intervention group consisted of hydrocolloid dressing and the second intervention group, including transparent film dressing and control group
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Nohom day hospital
Full name of responsible person
Neda Sabahi
Street address
Parastar Ave- Nohom day hospital
City
Torbat heydarieh
Province
Razavi Khorasan
Postal code
9518831166
Phone
+98 51 5222 6016
Email
9day@thums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Dr Shala Khosravan
Street address
Em khomeini Ave-Gonabad univercity of medicine
City
Gonabad
Province
Razavi Khorasan
Postal code
۹۶۹۱۷۹۳۷۱۸
Phone
+98 51 5722 3028
Email
Info@gmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gonabad 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
Gonabad University of Medical Sciences
Full name of responsible person
Neda Sabahi
Position
Master of science
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Emam khomeini Ave
City
Gonabad
Province
Razavi Khorasan
Postal code
۹۶۹۱۷۹۳۷۱۸
Phone
+98 51 5722 3038
Email
Nedasabahi123@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Neda Sabahi
Position
Master of science
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Emam khomeini Ave
City
Gonabad
Province
Razavi Khorasan
Postal code
۹۶۹۱۷۹۳۷۱۸
Phone
+98 515773028
Email
Nedasabahi123@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Neda Sabahi
Position
Master of science
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Emam khomeini Ave
City
Gonabad
Province
Razavi Khorasan
Postal code
۹۶۹۱۷۹۳۷۱۸
Phone
+98 51 5722 3028
Email
Nedasabahi123@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
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be 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