Determining the effectiveness of Simvastatin 2% topical ointment in the treatment of grade 1 and 2 bed sores
Design
Phase one and two randomized clinical trial on 104 patients with bedsores Grade 1 and 2, will be used for the randomization of Othello.
Settings and conduct
In this clinical study, phase one and two, the effectiveness of simvastatin 2% ointment on bed sores, 104 patients with grade 1 and 2 bed sores hospitalized in Rasoul Akram Hospital were randomly divided into two groups through a table of numbers. One group will be treated with 2% simvastatin ointment and one group will be treated with a new dressing for 14 days. Patients will be evaluated for wound healing on days 7 and 14.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patients with grade 1 and 2 bed sores based on physician diagnosis and Stirling Pressure Sore Severity Scale
Criteria for not entering:
1. Patients who have grade 3 and 4 bed sores or their sores are progressing to grade 3 and 4.
2. Patients whose wound is acutely infected or at high risk of infection.
3. Patients whose length of hospital stay is less than 14 days.
4. Pregnant and lactating women
Intervention groups
The intervention group will be treated with simvastatin 2% ointment prepared in the laboratory of Islamic Azad School of Pharmacy for 14 days.
The control group will be treated with the new dressing for 14 days.
Main outcome variables
Reduce wound size and grade
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210423051047N1
Registration date:2021-05-16, 1400/02/26
Registration timing:prospective
Last update:2021-05-16, 1400/02/26
Update count:0
Registration date
2021-05-16, 1400/02/26
Registrant information
Name
somayyeh nasiripour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 86701
Email address
nasiripours@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-06, 1400/03/16
Expected recruitment end date
2021-08-11, 1400/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The assesment of the effect of topical simvastatin 2% ointment in patients with bedsore grade 1,2: A randomized controlled clinical trial
Public title
The effect of simvastatin 2% ointment on bed sores
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with grade 1 and 2 bed sores
Exclusion criteria:
Patients with severely infected wounds or a high risk of infection.
Patients whose length of hospital stay is less than 14 days.
Pregnant and lactating women
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
104
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization using a table of random numbers
People will be given a two-digit code, and to select sample people from the table, it will randomly start from a point in the table in the direction of the column.
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 Islamic Azad Tehran Medical Sciences University- Pharmacy and Pharmaceutical Bra
Street address
First Glacier St.Gholhak. Dr. Shariati St.
City
Tehran
Province
Tehran
Postal code
1941933111
Approval date
2020-11-10, 1399/08/20
Ethics committee reference number
IR.IAU.PS.REC.1399.214
Health conditions studied
1
Description of health condition studied
Stage I Bedsore
ICD-10 code
L89.0
ICD-10 code description
Stage I decubitus ulcer and pressure area
2
Description of health condition studied
Stage II Bedsore
ICD-10 code
L89.1
ICD-10 code description
Stage II decubitus ulcer
Primary outcomes
1
Description
Reducing wound size
Timepoint
7 and 14 days after the intervention
Method of measurement
Ruler
Secondary outcomes
1
Description
Reduce the length of hospital stay
Timepoint
Daily after intervention
Method of measurement
Observational
Intervention groups
1
Description
The intervention group consisted of 52 patients with grade 1 and 2 bed sores who were treated with simvastatin 2% ointment (as daily) prepared in the laboratory of the Islamic Azad School of Pharmacy for 14 days.
Category
Treatment - Drugs
2
Description
The control group consisted of 52 patients with grade 1 and 2 bed sores who will be treated with a new dressing (as daily) for 14 days.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasoul Akram Hospital
Full name of responsible person
Somayyeh Nasiripour
Street address
Niayesh St. Sattarkhan
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6655 8811
Email
nasiripours@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Farshad Hashemian
Street address
Yakhchal St.Gholhak. Dr. Shariati St
City
Tehran
Province
Tehran
Postal code
1941933111
Phone
+98 21 2264 0051
Email
nasiripours@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
1
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
Iran University of Medical Sciences
Full name of responsible person
Somayyeh Nasiripour
Position
Assistant Professor of Clinical Pharmacy
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Niayesh St, Sattarkhan
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6655 8811
Email
nasiripours@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Somayyeh Nasiripour
Position
Assistant Professor of Clinical Pharmacy
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
niayesh St, Sattarkhan
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
0982166558811
Email
nasiripours@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Somayyeh Nasiripour
Position
Assistant Professor of Clinical Pharmacy
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
niayesh St, Sattarkhan
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6655 8811
Email
nasiripours@yahoo.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
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
No - There is not 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
The results of the study will be published as an article.
When the data will become available and for how long
September 2021
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
After the written letter requesting the information to be published, the request will be evaluated by the responsible persons and the information will be available while protecting the rights of the responsible persons.
From where data/document is obtainable
Dr. Somayyeh Nasiripour, Assistant Professor of Clinical Pharmacy, Iran University of Medical Sciences
Email: nasiripours@yahoo.com
What processes are involved for a request to access data/document
After the written letter requesting the information to be published, the request will be evaluated by the responsible persons and the information will be available while protecting the rights of the responsible persons.