Protocol summary

Study aim
Comparison of microbial culture, duration of wound closure, amount of wound exudate over time in the control group, and plasma in patients with salicylic ulcers.
Design
In this study, blinding is done in a two-way blind way. The second phase of the clinical trial is on a group of 142 people, since the list of patients is not known in advance and the number of patients is not known. Every other day, plasma treatment or standard treatment is performed on the patients until A total of 71 subjects were obtained for each treatment. If 71 people are reached in the plasma or standard group, the treatment that has been completed is stopped.
Settings and conduct
one of the treatment groups, i.e. standard treatment alone or standard treatment together with plasma radiation treatment, and we conduct the study in a double-blind manner. Microbial culture will be done from the wounds of all participants at the beginning, the second week of treatment and the end of treatment, then the images will be analyzed with ImageJ software. Hospital of Damghan province
Participants/Inclusion and exclusion criteria
1- Age above 18 years. 2- Not having a history of radiation therapy. 3- Not taking chemotherapy drugs. 4- Not taking drugs that suppress the body's immune system. 5- Not having a severe infection that requires hospitalization. 6- Not having a severe bone infection (Osteomyelitis).
Intervention groups
The standard treatment of Salk includes the injection of glucantim ampoules, and in the second group, i.e., the standard treatment with plasma radiation during 10 alternating sessions, in addition to the standard treatment, the patient's wound is swept with plasma radiation for 2 minutes.
Main outcome variables
Changes in the appearance and size of the wound after plasma processing؛ Reducing the rate of wound infection

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160514027888N3
Registration date: 2023-04-17, 1402/01/28
Registration timing: prospective

Last update: 2023-04-17, 1402/01/28
Update count: 0
Registration date
2023-04-17, 1402/01/28
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2990 4031
Email address
m_khani@sbu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-22, 1402/04/01
Expected recruitment end date
2024-09-22, 1403/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of using atmospheric cold plasma radiation to heal wound healing in cutaneous leishmaniasis
Public title
Cutaneous Leishmaniasis Wound Healing with Cold Plasma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
No history of radiation therapy. Not taking chemotherapy drugs. Not taking drugs that suppress the immune system. Not having a severe infection that requires hospitalization. Not having a severe bone infection Lack of breastfeeding.
Exclusion criteria:
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 142
Randomization (investigator's opinion)
Randomized
Randomization description
The second phase of the clinical trial is on a group of 142 people since the list of patients is not known in advance and the number of patients is not known. A total of 71 subjects were obtained for each treatment. In case of reaching 71 people in the plasma or standard group, the treatment that has been completed is stopped and the only treatment that still needs patients (71 patients) is performed on people.
Blinding (investigator's opinion)
Double blinded
Blinding description
In the first group, plasma devices are used in the state where the gas flow is on and the patient will feel the gas flow, and in the second group, standard treatment with plasma radiation during 10 alternating sessions, the patient's wound with plasma radiation with a duration of 2 The minute is swept away. The condition of the wound is checked every week during the treatment, and when the wound is completely healed, the treatment is stopped, and the patient's condition will be followed up to one month later.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Semnan University of Medical Sciences
Street address
Basij Boulevard, University of Medical Sciences and Health Services
City
Semnan
Province
Semnan
Postal code
3514799442
Approval date
2022-10-10, 1401/07/18
Ethics committee reference number
IR.SEMUMS.REC.1401.167

Health conditions studied

1

Description of health condition studied
Cutaneous leishmaniasis
ICD-10 code
B55.1
ICD-10 code description
Cutaneous leishmaniasis

Primary outcomes

1

Description
Changes in wound area and wound infection rate
Timepoint
Before treatment, after two weeks and at the end of treatment
Method of measurement
Imaging and microbial culture

Secondary outcomes

empty

Intervention groups

1

Description
Control group: The standard treatment of Salk includes injection of glucantim ampoules
Category
Treatment - Drugs

2

Description
Intervention group: Standard treatment along with plasma radiation during 10 alternating sessions
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Health center and hospital of Damghan province
Full name of responsible person
Abolfazl Fattah
Street address
after Islamic Azad University، Cheshme Ali Blvd
City
Damghan
Province
Semnan
Postal code
3671637881
Phone
+98 23 3522 5120
Email
Drabolfazlfatah@gmail.com
Web page address
https://velayathos.semums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Abolfazl Fattah
Street address
Semnan University of Medical Sciences and Health Services، Basij Blvd
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3344 1022
Email
info@semums.ac.ir
Web page address
https://semums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Abolfazl Fattah
Position
Head of Damghan Province Hospital
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
After Islamic Azad University، Cheshme Ali Blvd
City
Damghan
Province
Semnan
Postal code
3671637881
Phone
+98 23 3522 5120
Email
Drabolfazlfatah@gmail.com
Web page address
https://velayathos.semums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Abolfazl Fattah
Position
Head of Damghan Province Hospital
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
After Islamic Azad University, Cheshme Ali Blvd
City
Damghan
Province
Semnan
Postal code
3671637881
Phone
+98 23 3522 5120
Email
Drabolfazlfatah@gmail.com
Web page address
https://velayathos.semums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahid beheshti University
Full name of responsible person
Mohammadreza Khani
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Plasma Engineering
Street address
Shahid beheshti University، Velenjak
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2990 4017
Email
m_khani@sbu.ac.ir
Web page address
http://facultymembers.sbu.ac.ir/khani/

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
Not applicable
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Publication of scientific research articles and ISI
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Checking the effectiveness of the treatment process
From where data/document is obtainable
Dr. Mohammad Reza Khani, member of the faculty of Shahid Beheshti University, 09122531497
What processes are involved for a request to access data/document
The request will be sent via email to m_khani@sbu.ac.ir and will be answered within 30 working days after review.
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