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Preparation, characterization and clinical evaluation of the effectiveness of a cotton-based topical product in stopping bleeding from the leech therapy wound

Protocol summary

Study aim
Preparation, characterization and clinical efficacy of cotton-based product in stopping bleeding from leech therapy site
Design
A controlled, parallel-group unblinded randomized phase 3 clinical trial on twenty patients. Blocked randomization
Settings and conduct
40 bleeding wounds from the site of leech therapy in 20 patients referred to centers under the supervision of the university who meet the eligibility criteria will be studied after signing the informed consent. In the intervention group, the wound site will be dressed with a cotton-based composition, and in the control group, this dressing will be done by routine method with sterile gas. In each patient, two wounds will be measured: one wound randomly (by block method) in the intervention group and the other wound in The patient will be placed in the control group.
Participants/Inclusion and exclusion criteria
inclusion criteria: adults with leech therapy indication Conditions of non-entry:clinical or laboratory evidence of coagulation disorder; patients taking drugs affecting coagulation,including antiplatelets, anticoagulants,hemostatic agents such as tranexamic acid,vitamin K, aminocaproic acid and statins,oral contraceptives,herbal medicines containing garlic and ginger;diseases Bleeding, liver cirrhosis,chronic kidney failure,malignancy,skin sensitivity to the product,menstrual periods,facial leech therapy
Intervention groups
Intervention group: dressing with cotton-based topical product Control group: usual dressing
Main outcome variables
Determining the percentage of wounds whose bleeding stops completely after fifteen minutes after local administration of the product.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220625055267N1
Registration date: 2023-05-18, 1402/02/28
Registration timing: prospective

Last update: 2023-05-18, 1402/02/28
Update count: 0
Registration date
2023-05-18, 1402/02/28
Registrant information
Name
Fatemeh Akbari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3256 6725
Email address
akbarif981@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-23, 1402/05/01
Expected recruitment end date
2025-03-21, 1404/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Preparation, characterization and clinical evaluation of the effectiveness of a cotton-based topical product in stopping bleeding from the leech therapy wound
Public title
Clinical evaluation of the effectiveness of a topical product prepared from cotton in stopping bleeding from the site of leech therapy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Adults who have leech therapy indication according to the doctor's opinion.
Exclusion criteria:
Clinical or laboratory evidence of coagulation disorder (ecchymosis, hematoma, petechiae purpura or disorder in PT, PTT, hemoglobin, platelets, glucose, calcium, urea, creatinine) Patients who take drugs that affect coagulability, including anti-platelets (aspirin, clopidogrel (Plavix), dipyridamole (Perzantin), ticlopidine (Ticlid), anticoagulants (warfarin, enoxaparin, rivaroxaban, heparin, streptokinase, etc.), blood thinners such as tranexamic acid, vitamin K, aminocaproic acid and statins and oral contraceptives and herbal anticoagulants such as products containing ginger and garlic بیماران دارای اختلالات خونریزی دهنده مثل ITP، هموفیلی ، سیروز کبدی، نارسایی مزمن کلیه Patients with various malignancies Menstruating women Leech therapy in the face area Skin sensitivity to the product
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 20
More than 1 sample in each individual
Number of samples in each individual: 2
In each patient, the number of two bleeding wounds will be measured: one wound will be randomly (blocked) in the intervention group and the other wound will be in the control group.
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: block Randomization Unit: Individual Randomization tool: sealed envelope How to generate random sequence: Manually The patients of two groups are named with codes A and B and the size of the blocks is selected. Number 1 (in the order of ABAB) is selected in the lottery, the first patient will receive treatment A, the second patient will receive treatment B, the third patient will receive treatment A, and the fourth patient will receive treatment B. The fifth patient will be randomly selected from one of the 4 blocks and the type of treatment will be assigned to the fifth to eighth patients according to the block. A selection number has been assigned for each of the 6 blocks and the selection method of each of the blocks will be lottery style.
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 mashhad University of Medical Sciences
Street address
University Street, Mashhad University of Medical Sciences
City
Mashhad
Province
Razavi Khorasan
Postal code
13944-91388
Approval date
2023-04-07, 1402/01/18
Ethics committee reference number
IR.MUMS.REC.1402.018

Health conditions studied

1

Description of health condition studied
Bleeding from the site of leech therapy
ICD-10 code
D69.9
ICD-10 code description
Coagulation defect, unspecifiez, Haemorrhagic condition, unspecified

Primary outcomes

1

Description
The percentage of wounds whose bleeding will be completely stopped after local administration of the product
Timepoint
Fifteen minutes after using the product
Method of measurement
Monitoring bleeding from the site by clinical observation

Secondary outcomes

1

Description
clinical Bleeding from the site of leech therapy after the patient leaves the clinic
Timepoint
After leaving the clinic up to 72 hours after using the product
Method of measurement
Observing bleeding from the wound site

2

Description
Possible side effects caused by the administration of the product within 72 hours after the administration of the product
Timepoint
From the time of leaving the clinic until 72 hours later
Method of measurement
Reporting the complication by the patient

Intervention groups

1

Description
Intervention group: Dressing the site of leech therapy with a topical product based on cotton
Category
Treatment - Other

2

Description
Control group: Dressing the site of leech therapy with routine dressing
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Traditional Medicine Clinic of Imam Reza Hospital
Full name of responsible person
Mahdi Yousefi
Street address
Ibn Sina Street, Imam Reza (AS) Hospital Square, Imam Reza (AS) Educational Research and Treatment Center
City
Mashhad
Province
Razavi Khorasan
Postal code
٩١٣٧٩١٣٣١۶
Phone
+98 51 3854 3031
Email
yousefim@mums.ac.ir

2

Recruitment center
Name of recruitment center
Takhti Traditional Medicine Clinic
Full name of responsible person
Mahdi Yousefi
Street address
Takhti Square, South Motahari Center
City
Mashhad
Province
Razavi Khorasan
Postal code
9139913113
Phone
+98 51 3713 1032
Email
yousefim@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Majid Ghayor Mobarhan
Street address
University St., Qurashi Building, Research and Technology Vice-Chancellor of Mashhad University of Medical Sciences
City
Mashhad
Province
Razavi Khorasan
Postal code
1394491388
Phone
+98 51 3841 2081
Email
vcresearch@mums.ac.ir
Web page address
http://v-research.mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Fatemeh Akbari
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Azadi Square, east door of university campus, Faculty of Iranian and Complementary Medicine
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 3884 8931
Email
akbarif981@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mahdi Yousefi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Azadi Square, University Campus, Faculty of Iranian and Complementary Medicine
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3884 8930
Email
yousefim@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fatemeh Akbari
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Azadi square, east door of university campus, faculty of medicine Iranian and complementary to Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 3884 8931
Email
akbarif981@mums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
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
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