Comparative study of the effect of hydrocolloid dressing and alpha ointment on pressure ulcer healing in elderly patients hospitalized in intensive care units
Comparative study of the effect of hydrocolloid dressing and alpha ointment on pressure ulcer healing in elderly patients hospitalized in intensive care units
Design
This study is a one-blind clinical trial. The study population will be all patients referred to Shohada hospital of Kermanshah. 126 eligible patients will be selected conveniently and randomly assigned to two intervention groups.
Settings and conduct
The study, which will be conducted at Shohada hospital of Kermanshah, is one-blind one, that the data analyzer will kept blind to the allocation of study groups. Prior to any intervention, the wound characteristics will be recorded in a checklist based on the Pressure Ulcer Scale (PUSH).
Participants/Inclusion and exclusion criteria
Inclusion criteria: More than 60 years old; Patients with pressure ulcers
Exclusion criteria: People with diabetes
Intervention groups
The first intervention group will receive an alpha ointment daily for 5 weeks after thoroughly rinsing the wound with normal saline and drying it with sterile gas. The second intervention group will receive hydrocolloids every 48 to 72 hour for 5 weeks, after rinsing the wound with normal saline and drying it with sterile gas
Main outcome variables
Wound healing
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130812014333N144
Registration date:2020-03-29, 1399/01/10
Registration timing:prospective
Last update:2020-03-29, 1399/01/10
Update count:0
Registration date
2020-03-29, 1399/01/10
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-08, 1399/01/20
Expected recruitment end date
2020-06-04, 1399/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of the effect of hydrocolloid dressing and alpha ointment on pressure ulcer healing in elderly patients hospitalized in intensive care units
Public title
Comparative study of the effect of hydrocolloid dressing and alpha ointment on pressure ulcer healing in elderly patients hospitalized in intensive care units
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
More than 60 years old
Patients with pressure ulcers
Exclusion criteria:
People with diabetes
Age
From 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
Data analyser
Sample size
Target sample size:
126
Randomization (investigator's opinion)
Randomized
Randomization description
Using the random number table, patients are divided into two groups of 63. Each patient is assigned a 4-digit code based on the random number table, Based on the right number of patients code, the patients are divided into two groups. Patients whose last digit is 0, 2, 4, 6, 8 will be assigned to the first intervention group and patients whose last digit is 1,3,5, 7, 9 will be assigned to the second intervention group.
Blinding (investigator's opinion)
Single blinded
Blinding description
The data analyzer was kept blind to the allocation of study groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2020-02-04, 1398/11/15
Ethics committee reference number
ir.kums.rec.1398.1146
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
Wound healing
Timepoint
Baseline, once a week for 5 weeks
Method of measurement
Based on observation
Secondary outcomes
empty
Intervention groups
1
Description
The first intervention group will receive an alpha ointment daily for 5 weeks after thoroughly rinsing the wound with normal saline and drying it with sterile gas
Category
Treatment - Other
2
Description
The second intervention group will receive hydrocolloids every 48 to 72 hour for 5 weeks, after rinsing the wound with normal saline and drying it with sterile gas
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohada Hospital
Full name of responsible person
Samin Sharifi
Street address
Shohada Hospital, Shahid Beheshti Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6714663156
Phone
+98 83 3835 4115
Email
sohabeh.sa15@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Farid Najafi
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
fnajafi@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Samin Sharifi
Position
MSc in Elderly Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Dolatabad Blvd, Isar Square
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3826 6429
Email
sohabeh.sa15@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Parvin Abbasi
Position
Member of Kermanshah University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Nursing Education
Street address
Faculty of Nursing and Midwifery, Dolatabad Blvd, Isar Square
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3826 6429
Email
P_abasi2003@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Samin Sharifi
Position
MSc in Elderly Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Dolatabad Blvd, Isar Square
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3826 6429
Email
sohabeh.sa15@gmail.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
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The main outcomes of the study will be shared.
When the data will become available and for how long
3 months
To whom data/document is available
If requested, results will be made available to other academic researchers
Under which criteria data/document could be used
Collected data is confidential and will not be shared with anyone else
From where data/document is obtainable
Send E-mail to the responsible for the update to get the documentation
What processes are involved for a request to access data/document
Documentation will be emailed within a 15-day timeframe