evaluation effects of heparin gel versus placebo in pressure ulcer
Design
The study population consisted of all patients with pressure ulcer hospitalized in the Clinical Research Development Unit of Imam Reza Hospital in Kermanshah. Fifety-eight patients will be included in the study by available method and will be randomly assigned to one of the study groups.
Settings and conduct
Imam Reza hospital, heparin and placebo pills will be prepared by a pharmacist who is unaware of patients allocation.
Participants/Inclusion and exclusion criteria
all patients with stage 2 pressure ulcer who sign the inform consent
Intervention groups
Identical carboxy-methyl celluluse base heparin or placebo gel will be prepared in pharmaceutics lab. Heparin gel (200 Unite/g) applied daily for 30 days. All patients will received standard wound care and intevention (or placebo) will be added to standar therapy
Main outcome variables
In both groups, the wound will be examined during the days 1,3,7,14,21,30 by a trained and skilled wound dresser and its features (depth, size, wound discharge) will be carefully documented.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190624043993N1
Registration date:2019-12-25, 1398/10/04
Registration timing:registered_while_recruiting
Last update:2019-12-25, 1398/10/04
Update count:0
Registration date
2019-12-25, 1398/10/04
Registrant information
Name
foroud shahbazi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3426 6780
Email address
foroud08@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-21, 1398/04/30
Expected recruitment end date
2020-02-20, 1398/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of effects of heparin gel versus placebo on stage 2 pressure ulcers: a randomized controlled trial study
Public title
effects of heparin gel on pressure sore treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
all patients with pressure sore stage II
Exclusion criteria:
not sign informed consent
active bleeding
low platelet count
Age
From 18 years old to 100 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Randomized
Randomization description
block randomization
Blinding (investigator's opinion)
Double blinded
Blinding description
Randomized double- blind (Patients and assessor)
Placebo
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
Shahid Beheshti Blvd,
City
Kermanshah
Province
Kermanshah
Postal code
1673-67145
Approval date
2019-11-26, 1398/09/05
Ethics committee reference number
IR.KUMS.REC.1398.826
Health conditions studied
1
Description of health condition studied
Grade 2 Pressure Ulcer
ICD-10 code
L89
ICD-10 code description
Pressure ulcer
Primary outcomes
1
Description
Effects of heparin gel compared with placebo on pressure ulcer status (depth, size, and secretion)
Timepoint
1،3،7،14،21،30
Method of measurement
Depth, diameter, and wound secretion of both group will be evaluated until day-30 of treatment
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group will receive heparin gel daily for one month
Category
Treatment - Drugs
2
Description
The control group will receive placebo gel daily for one month
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Foroud Shahbazi
Street address
Parastar Blv
City
kermanshah
Province
Kermanshah
Postal code
1673-67145
Phone
+98 83 3427 6493
Email
foroud08@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
083-34276493
Phone
+98 83 3427 6489
Email
Foroud08@gmail.com
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
Kerman University of Medical Sciences
Full name of responsible person
Foroud Shahbazi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Parastar Blve
City
kermanshah
Province
Kermanshah
Postal code
083-34276493
Phone
+98 83 3426 6780
Email
foroud08@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Foroud Shahbazi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Parastar blve
City
Kermanshah
Province
Kermanshah
Postal code
083-34276489
Phone
+98 83 3426 6780
Email
Foroud08@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Foroud Shahbazi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Parastar Blve
City
Kermanshah
Province
Kermanshah
Postal code
083-34276493
Phone
+98 83 3427 6489
Email
foroud08@gmail.com
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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Evaluation of effects of heparin gel versus placebo on stage 2 pressure ulcers: a randomized controlled trial study
When the data will become available and for how long
patients data without name
To whom data/document is available
All investigators
Under which criteria data/document could be used
according to our institution roles
From where data/document is obtainable
Principle Investigators
What processes are involved for a request to access data/document