Comparative effect of different suture techniques on blepharoplasty surgery scar in patients referred to Arak educational and medical centers: Clinical trial
Comparative effect of different suture techniques in blepharoplasty surgery in patients referred to Arak Medical Center
Design
Sutures are made on a patient's two eyes, with one eye being randomly sutured with a simple suture and the other with a subcutaneous suture. We do not have blindness, the sample size is 20 patients .The area is photographed by the researcher (plastic surgeon).One and six months after surgery, the area is examined
Settings and conduct
Background: Comparison of surgical repair site with Sochour two techniques
Location: Arak Educational and Medical Centers
Procedure: After suturing the patient's two eyes, which are selected as a random permutation block, a simple subcutaneous patch is closed. : One and six months later, the physician uses the Vancouver Scale to assess and score the scar area.
Participants/Inclusion and exclusion criteria
All patients who are candidates for elective cosmetic eyelid surgery (blepharoplasty)that referred the educational training center;
exclusion criteria:
If the patient voluntarily leaves the study
Intervention groups
One eye is repaired with a simple separate incision and the other eye is repaired with a subcutaneous suture. The patient's eyes are involved in the intervention.
Main outcome variables
Improving scar tissue in terms of color, redness, flexibility and swelling
General information
Reason for update
Acronym
ندارد
IRCT registration information
IRCT registration number:IRCT20201006048950N2
Registration date:2021-12-04, 1400/09/13
Registration timing:registered_while_recruiting
Last update:2021-12-04, 1400/09/13
Update count:0
Registration date
2021-12-04, 1400/09/13
Registrant information
Name
Mahboobeh Khosravani
Name of organization / entity
Arakuniversity of medical science
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3505
Email address
mahboobkhosravani@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-24, 1400/07/02
Expected recruitment end date
2022-02-21, 1400/12/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative effect of different suture techniques on blepharoplasty surgery scar in patients referred to Arak educational and medical centers: Clinical trial
Public title
Comparison of the effect of blepharoplasty scar with two suture methods
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 65-18 years
Complete of the informed consent form
Exclusion criteria:
Conditions and diseases in which the immune system is weakened and wound healing is delayed (diabetes, cancer, immunosuppressive drugs, corticosteroids, congenital lesions, scars from trauma surgery)
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
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
One and six months after the surgery, the area is observed by the researcher (specialist and plastic surgeon) and the patient's eye is photographed at each stage.
Randomization (investigator's opinion)
Randomized
Randomization description
Randomly, one eye is repaired with a simple severed suture and the other eye with a subcutaneous suture.We use the random permutation block method for randomization.Because a patient's two eyes are used in the intervention.There is no moral problem. The researcher randomly assigns the type of suture to each patient's eyes.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
not
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Arak University of Medical Sciences
Street address
Basij square. Sardasht alley, the complex of the Great Prophet. Second floor. Vice Chancellor for Research, Arak University of Medical Sciences
City
ARAK
Province
Markazi
Postal code
3813734197
Approval date
2021-08-08, 1400/05/17
Ethics committee reference number
IR.ARAKMU.REC.1400.125
Health conditions studied
1
Description of health condition studied
elective cosmetic eyelid surgery (blepharoplasty)
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Improving scar tissue in terms of color, redness, flexibility and swelling
Timepoint
One and six months after surgery
Method of measurement
Vancouver scale, which includes: in terms of color, vascularity, flexibility, height.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: is a patient eye (left or right).that suture is separately simple
Category
Treatment - Surgery
2
Description
Intervention group 2: Another eye (left or right). that suture is suubcutaneous.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
All educational medical centers of Arak University of Medical Sciences
Full name of responsible person
mahboobe khosravani
Street address
Shahid Beheshti St. Meysam Street .Adli Alley .Rastak Complex
City
ARAK
Province
Markazi
Postal code
3813734197
Phone
+98 86 3224 0507
Fax
Email
mahboobkhosravani@arakmu.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
mahboobeh khosravani
Street address
Shahid Beheshti St. Meysam Street .Adli Alley .Rastak Complex
City
Arak
Province
Markazi
Postal code
3813734197
Phone
+98 86 3224 0507
Email
mahboobkhosravani@arakmu.ac.ir
Grant name
Arak University of Medical Sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Mahboobeh Khosravani
Position
University faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Abbas Abad Street. Meysam Street .Adli Alley .Rastak Complex
City
ARAK
Province
Markazi
Postal code
3813734197
Phone
+98 86 3224 0507
Email
mahboobkhosravani@arakmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mahboobeh khosravani
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Abbas Abad َAve. Meysam Blvd .Adli Alley .Rastak Complex
City
Arak
Province
Markazi
Postal code
3813734197
Phone
+98 86 3224 0507
Email
mahboobkhosravani@arakmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mahboobeh Khosravani
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Abbas Abad Street. Meysam Street .Adli Alley .Rastak Complex
City
Arak
Province
Markazi
Postal code
3813734197
Phone
+98 86 3224 0507
Email
mahboobkhosravani@arakmu.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