a) the role of Fibrinolysin in open wound management via using a vacuum dressing in Imam Khomeini Hospital Tehran 2022-2023
b) benefits of using Fibrinolysin in open wound management through using a vacuum dressing in Imam Khomeini Hospital Tehran 2022-2023
c) time for wound healing with and without Fibrinolysin upon the surface area of wounds through using a vacuum dressing in Imam Khomeini Hospital Tehran 2022-2023
d) comorbidities by using Fibrinolysin in open wound management through using a vacuum dressing in Imam Khomeini Hospital Tehran 2022-2023
e) complications in using Fibrinolysin in open wound management through using a vacuum dressing in Imam Khomeini Hospital Tehran 2022-2023
Design
Fibrinolysin Intervention group, non-fibrinolysin control group, sample size 22, Randomised Control Trial, single-center, enrolled in the year 2022
Settings and conduct
The blocking method is used for randomization and the numbering and tagging of blocks will be four. Blinding will be performed on patients and they will not be aware that they are in the intervention or control group. In addition, the selection of patients in each group will be available by the method.
Participants/Inclusion and exclusion criteria
This study includes all patients with the same type and of similar size of the open wound which will be managed via Vacuum Dressing admitted in the imam Khomeini hospital, Tehran, Iran from 2022 to 2023.
Intervention groups
1 Topical Ointment Westagen Pars Fibrinolysin 20g per patient
Used for 24 Hours
1 session
It cleans dead tissues from wounds and causes the dilution of pus and dissolution of blood clots. Removes dead tissues from the surface of the skin. Side effects of fibrinolysin ointment: redness, burning, and inflammation.
Main outcome variables
In this study, we will assess the effect of fibrinolysin on the size, depth, and type of open wound.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221112056478N1
Registration date:2022-11-20, 1401/08/29
Registration timing:prospective
Last update:2022-11-20, 1401/08/29
Update count:0
Registration date
2022-11-20, 1401/08/29
Registrant information
Name
Syed Raees Abbas
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 930 601 6389
Email address
raeesnaqvi45@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-26, 1401/09/05
Expected recruitment end date
2022-12-06, 1401/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of open wound management via vacuum dressing with and without fibrinolysin
Public title
Comparison of open wound management with dressing with and without ointment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
all patients with the same type of open wound will be managed via Vacuum Dressing in the imam Khomeini hospital, Tehran, Iran from 2022 - 2023.
all patients with similar size of the open wound which will be managed via Vacuum Dressing admitted to the imam Khomeini hospital, Tehran, Iran from 2022 - 2023.
Exclusion criteria:
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
This is a clinical trial study in which, with the help of random allocation of eligible patients, patients are placed in two groups an interventional group and a control group.
The blocking method is used for randomization and the numbering and tagging of blocks will be four. Blinding will be performed on patients and they will not be aware that they are in the intervention or control group. In addition, the selection of patients in each group will be available by the method.
Blinding (investigator's opinion)
Single blinded
Blinding description
Blinding will be performed on patients and they will not be aware that they are in the intervention or control group. In addition, the selection of patients in each group will be available by the method.
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee in Research of Imam Khomeini Hospital Complex - Tehran University of Medical Scienc
Street address
Tehran, Quds town (west), between South Flamek and Zarafshan, Simai Iran St., Central Headquarters of the Ministry of Health, Treatment and Medical Education, Block A, 13th floor.
City
Tehran
Province
Tehran
Postal code
1419733141
Approval date
2022-09-03, 1401/06/12
Ethics committee reference number
IR.TUMS.IKHC.REC.1401.122
Health conditions studied
1
Description of health condition studied
Open Wound
ICD-10 code
S01
ICD-10 code description
Primary outcomes
1
Description
Wound Healing with fibrinolysin
Timepoint
24 hours
Method of measurement
Imito measure application
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Fibrinolysin Group
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital Complex, Tehran University of Medical Sciences
Full name of responsible person
Doctor Narjes Muhammadzadeh
Street address
Imam Khomeini Hospital Complex, Tehran University of Medical Sciences Tehran, Quds town (west), between South Flamek and Zarafshan, Simai Iran St., Central Headquarters of the Ministry of Health, Treatment and Medical Education, Block A, 13th floor.
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2609
Email
surg-depart-research@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Doctor Narjes Muhammadzadeh
Street address
Surgery Ward 5 - Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran
City
Tehran
Province
Tehran
Postal code
1416634793
Phone
+98 21 6119 2609
Email
surg-depart-research@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
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
Syed Raees Abbas
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Taleghani Street - Mosavi Street - Building no. 76
City
Tehran
Province
Tehran
Postal code
1583769433
Phone
+98 930 601 6389
Fax
Email
raeesnaqvi45@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Syed Raees Abbas
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Taleghani Street - Mosavi Street - Building no. 76
City
Tehran
Province
Tehran
Postal code
1583769433
Phone
+98 930 601 6389
Fax
Email
raeesnaqvi45@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Syed Raees Abbas
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Taleghani Street - Mosavi Street - Building no. 76
City
Tehran
Province
Tehran
Postal code
1583769433
Phone
+98 930 601 6389
Fax
Email
raeesnaqvi45@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
to keep patients information safe, codes will be assigned to patients data instead of using patient's names. Individual patient data will not be shared without approval from patient
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