Evaluation of the effect of plasma device in the treatment of keloid.
Design
The non-randomized , single arm trial
Settings and conduct
Patients undergo local analgesia using lidocaine gel, we use spot by spot technique of cold plasma, the number of plasma sessions depends on the height of the Keloid.the interval between treatment sessions is one month.patients were followed up for recurrence and complication up to five months after the last treatment session.Study perform in Amir Al- Momenin teaching hospital in Tehran .
Participants/Inclusion and exclusion criteria
Inclusion criteria :patients aged 18 to 70 years with keloid scar up to 5mm in height،voluntarily and with informed consent, to be able to follow up after treatment . Exclusion criteria: people with chronic medical condition that effects wound healing and with underlying skin condition that their disease is exacerbated by skin irritation and received scar treatment in the past 6 month.
Intervention groups
People with keloids whose lesions are evaluated before and after cold plasma treatment
Main outcome variables
Improves keloid scars;Pigmentation, Vascularity, Pliability, Height of keloid, Pain, Itchiness
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220512054827N1
Registration date:2022-07-20, 1401/04/29
Registration timing:retrospective
Last update:2022-07-20, 1401/04/29
Update count:0
Registration date
2022-07-20, 1401/04/29
Registrant information
Name
Sepideh Tehrani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2200 6660
Email address
stehrani@iautmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-08, 1399/01/20
Expected recruitment end date
2020-07-21, 1399/04/31
Actual recruitment start date
2020-04-08, 1399/01/20
Actual recruitment end date
2020-09-21, 1399/06/31
Trial completion date
2021-08-11, 1400/05/20
Scientific title
Effectiveness of Plasma Pen in the treatment of keloid scars
Public title
Plasma Pen in the treatment of keloid scars
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
18 to 70 years old patients with keloid scars
Volunteers who participated with informed consent
Patients who have Possibility for repeated visits and follow-ups
People with keloid scars with a maximum height of 5mm..
Exclusion criteria:
Patients who have history of previous treatments in the last six months
Patients who have any chronic medical conditions that affects wound healing.
People with underlying skin condition whose disease is exacerbated by skin irritations.
Age
From 18 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
30
More than 1 sample in each individual
Number of samples in each individual:
7
Keloid scars with a diameter of about 1 mm to a maximum of 5 mm
Actual sample size reached:
24
More than 1 sample in each individual
Actual sample size in each individual:
7
Keloid scars with a diameter of about 1 mm to a maximum of 5 mm
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran Islamic Azad University Of Medical Sciences
Street address
Islamic Azad University of Medical Sciences, Shariati St, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
19395/1495
Approval date
2021-01-04, 1399/10/15
Ethics committee reference number
IR.IAU.TMU.REC.1399.369
Health conditions studied
1
Description of health condition studied
Keloid Scars
ICD-10 code
L91.0
ICD-10 code description
Hypertrophic scar
Primary outcomes
1
Description
Keloid scar improvement
Timepoint
Before treatment and 5month after end of treatment
Method of measurement
Physical examination and scoring based on the Modified Vancouver Scar Scale
Secondary outcomes
1
Description
Patient's satisfaction
Timepoint
5 months after end of treatment
Method of measurement
Answer the patient by choosing one of the option:1)not changed 2) good 3)very good 4)excellent
2
Description
Postinflammatory hyperpigmentation (PIH)as Side effects of treatment
Timepoint
10 days, one month and 5 months after the intervention
Method of measurement
Physical examination
3
Description
Recurrence
Timepoint
10 days, one month and 3 month and 5 months after the intervention
Method of measurement
Physical examination and scoring based on the Modified Vancouver Scar Scale
Intervention groups
1
Description
In each treatment session,the scar anesthetized with lidocaine gel then the keloids are removed by spot by spot method using plasma plexr device model plus.scars with a height of 2mm and less have been treated for two session and scars with a height of more than 2mm up to 5mm have been performed for tree session. The interval between treatment session was one month.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir Al- Momenin Teaching Hospital, Islamic Azad University of Medical Sciences
Full name of responsible person
Sepideh Tehrani
Street address
Amir Al-Momenin Hospital, Shirmohammadi St., Naziabad Ave.
City
Tehran
Province
Tehran
Postal code
1811694784
Phone
+98 21 5534 6550
Fax
+98 21 5534 6301
Email
amhos@iautmu.ac.ir
Web page address
https://tms.iau.ir/amhos/fa
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University of Tehran Medical Sciences
Full name of responsible person
Sepideh Tehrani
Street address
Islamic Azad University of Medical Sciences, Shariati St, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1916893813
Phone
+98 21 2200 6660
Fax
+98 21 2200 6667
Email
Stehrani@iautmu.ac.ir
Web page address
https://tms.iau.ir/medical/fa
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University of Tehran 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
Islamic Azad University of Tehran Medical Sciences
Full name of responsible person
Sepideh Tehrani
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Islamic Azad University of Medical Sciences, Shariati St
City
Tehran
Province
Tehran
Postal code
19395/1495
Phone
+98 21 2200 6660
Email
Stehrani@iautmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University of Tehran Medical Sciences
Full name of responsible person
Sepideh Tehrani
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Islamic Azad University of Medical Sciences, Shariati St, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1916893813
Phone
+98 21 2200 6660
Email
Stehrani@iautmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University of Tehran Medical Sciences
Full name of responsible person
Shohreh delavar
Position
Medical doctor
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Islamic Azad University of Medical Sciences, Shariati St, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1916893813
Phone
+98 21 2200 6660
Fax
Email
shohreh.delavar@gmail.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
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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All study data will be shared, after unidentifiable individuals
When the data will become available and for how long
Start of access period 6 months after printing results
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
For further research
From where data/document is obtainable
Sepideh Tehrani
What processes are involved for a request to access data/document