Clinical evaluation of the topical effect of nanocomplex ointment on the healing process of chronic venous wounds
Design
A randomized, double-blind clinical trial in both intervention and control groups
Settings and conduct
1-Provide explanation to the patient
2-Signing the consent form
3-Examine and assess
4-active wounds.
5-Surgery by a general surgeon (the Vascular Surgery Clinic of Sina Hospital)
control
Wounds are washed with normal saline.Vaseline compression dressing
intervention
wounds are washed with normal saline and coverd with Promenton ointment and bandaged.
( once a day until the 14th day).
Each time an ointment is applied to the wound, it is applied to the wound surface.
(days 1, 7 and 14).
Participants/Inclusion and exclusion criteria
Inclusion C.
1-Age range 30 to 60 years
2- treatment of chronic venous ulcers.
3-The lesion is clinically benign.
Exclusion C.
1- clinically malignant.
2-The ability to create keloids or scars
3.Previous or current history of scroderma
4.History of radiotherapy
5.Immunosuppressive use or defective immune system
6.Pregnancy or breastfeeding
7.Patient dissatisfaction with continued use of ointment
Intervention groups
This clinical trial study was performed on 60 patients referred to the Vascular Surgery Clinic of Sina Hospital who complained of venous leg ulcers.
control :After surgery and cessation of bleeding in the control group, patients' wounds are washed with normal saline .Vaseline compression dressing is then applied to the wound.
intervention : After surgery and cessation of bleeding , patients' wounds are washed with normal saline .The patient's wound is covered with Promenton ointment and bandaged.Ointments are used once a day until the 14th day.
Each time an ointment is applied to the wound, it is applied to the wound surface.Patients are visited on days 1, 7 and 14.
Main outcome variables
Wound surface measurement
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160118026096N3
Registration date:2021-08-22, 1400/05/31
Registration timing:retrospective
Last update:2021-08-22, 1400/05/31
Update count:0
Registration date
2021-08-22, 1400/05/31
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2234 0598
Email address
takzaree@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-10, 1399/12/20
Expected recruitment end date
2021-06-20, 1400/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical Evaluation of Topical Nanocomplex ointment on Chronic venous ulcers: A double-blind randomized clinical trial
Public title
The effect of Topical Ointment on the Process of Wound Healing
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age range 30 to 60 years
Have referred for the treatment of chronic venous ulcers.
The lesion is clinically benign.6.
Exclusion criteria:
The lesion is clinically malignant.
The ability to create keloids or scars due to injuries
Previous or current history of scroderma
History of radiotherapy treatment
Immunosuppressive use or defective immune system
Pregnancy or breastfeeding
Patient dissatisfaction with continued use of ointment
Age
From 30 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
For randomization, the permuted block randomization will be used with quadruple blocks. Blocks will be generated using Excel software. In order to apply concealment in the randomization process, sealed envelopes will be used, and
Blinding (investigator's opinion)
Double blinded
Blinding description
Ointments will be given in the unbranded and untitled medical cans that patient and therapist be blind.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Room 60., Sixth Floor., Tehran University of Medical Sciences., Qods St., Tehran
City
Tehran
Province
Tehran
Postal code
1417613151
Approval date
2021-03-09, 1399/12/19
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1399.1254
2
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Room 60., Sixth Floor., Tehran University of Medical Sciences., Qods St., Tehran
City
Tehran
Province
Tehran
Postal code
1417613151
Approval date
2021-03-09, 1399/12/19
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1399.1254
Health conditions studied
1
Description of health condition studied
Wound Healing
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
En Wound Surface
Timepoint
Day one (surgery day), Day 4, 7 and 14 after surgery
Method of measurement
Wound healing is evaluated by measuring the wound surface, the percentage of wound healing, and the length of time needed for closure and complete repair of the wound. The surface of the wound is measured on days 1, 4, 7 and 14 after the surgery with Ferguson and Logan method. This is accomplished by placing the transparent paper on the wound and draw the wound shape. Then the transparent paper is transferred to the millimeter lattice paper and counted.
Secondary outcomes
1
Description
Wound resizing
Timepoint
The wound surface is digitally photographed on days 1, 7 and 14 after surgery.
Method of measurement
The wound surface is digitally photographed on days 1, 7 and 14 after surgery.The wound surface is then measured with Image J software.
2
Description
Inflammation rate
Timepoint
On days 1, 7 and 14, the amount of inflammation is determined by the doctor.
Method of measurement
Determination of inflammation by a doctor 0-3 score(none- mild- moderate- severe)
3
Description
Determining the amount of pain
Timepoint
On days 1, 7 and 14, the patient is asked about the amount of pain by the doctor.
Method of measurement
Based on patient questions and classification 0-10 score *(no pain 0 / mild pain 1-3/ moderate pain 4-6 / severe pain 7-9 / worst pain 10)
Intervention groups
1
Description
Intervention group: The intervention group in this study is a randomly selected 30-person group that uses an alternative medicine to improve the wound healing process. Surgery by a general surgeon After cessation of bleeding in the control group, patients' wounds are washed with normal saline solution. Apply some ointment on the wound and bandage it .(10 mg - Nanocomplex ointment - Dineh Company)Ointments are used once a day until the 14th day
Category
Treatment - Drugs
2
Description
Control group: The control group is a randomly selected 30-person group that uses conventional treatment Vaseline. In the intervention group, after rinsing with normal saline, the patient's wound is covered with ointment and bandaged.(10 mg - Vaseline - Kimidaro Company)Ointments are used once a day until the 14th day .
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Nasrin Takzaree
Street address
Tehran University of Medical Sciences.ebnsina ave.
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 8895 3008
Fax
+98 21 8895 3008
Email
takzaree@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr.Ali Sahraiyan
Street address
Tehran University of Medical Sciences,Qods Ave. Tehran
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 8895 3008
Fax
+98 21 8895 3008
Email
takzaree@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Nasrin Takzaree
Position
Assistant professor,School of Medicine, Tehran University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Histology
Street address
School of Medicine, Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 8895 3008
Fax
+98 21 8895 3008
Email
takzaree@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Nasrin Takzaree
Position
Assistant professor,School of Medicine, Tehran University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Histology
Street address
No.10 ,Porsina Ave.Tehran University of Medical Sciences,School of Medicine
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 8895 3008
Fax
+98 21 8895 3008
Email
takzaree@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Nasrin Takzaree
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Histology
Street address
No.10 ,Porsina Ave.Tehran University of Medical Sciences,School of Medicine
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 8895 3008
Fax
+98 21 8895 3008
Email
takzaree@tums.ac.ir
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
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Patient recovery results
When the data will become available and for how long
En 6 months after printing
To whom data/document is available
En Academic researchers
Under which criteria data/document could be used
Only recovery results are reported
From where data/document is obtainable
Dr. Nasrin Takzaree
What processes are involved for a request to access data/document