Protocol summary

Summary
Objectives:Evaluation and comparison of side effects and satisfaction of patient and physician in Micropunch Blepharopeeling versus blepharoplasty of the Upper Eyelids for Periorbital Rejuvenation in patients who referred to Alzahra hospital in 2016.The present study is a kind of controlled clinical pilot study in which 20 patients refer to the skin clinics affiliated to Esfahan University of Medical Science for periorbital rejuvenation . They are easily and nonrandomly included in the study and are randomly allocated to treatment groups of micropunch blephropeeling and blepharoplasty.After cleaning the face and injecting the local anesthetic in the upper eyelid region in the blepharopeeling group, peeling is performed in all the periocular region using phenol 89% and a cotton applicator until a white layer is formed. With a pair of iris scissors then, depending on the patient's skin thickness , 5-20 scissors cut , each 3-5 mm wide, are performed in a network model in the upper eyelid.the cuts are not sutured . they are however spontaneously epithelialized instead. After injecting the local anesthetic in the blepharoplasty group, the cuts are suprtficially performed with surgery blade NO.15 through the epiderm of the skin which have previously been marked are taken off. Hemostasis is performed with a cauter and the fats are taken out and cauterized . Both groups of the patients are visited for complications and the rate of the patient's satisfaction is rated 2 months after operation based on a 5 score scale . the level of the physician's satisfaction is registered pre-operatively and 2 months after operation using relevant photographs by 2 separate physicians on the low, medium, good and high scale.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016110330682N1
Registration date: 2016-12-07, 1395/09/17
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-12-07, 1395/09/17
Registrant information
Name
Behzad Bafandeh
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3668 0048
Email address
b.bafandeh@resident.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2015-07-23, 1394/05/01
Expected recruitment end date
2016-07-22, 1395/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation and comparison of side effects and satisfaction of patient and physician in Micropunch Blepharopeeling versus blepharoplasty of the Upper Eyelids for Periorbital Rejuvenation in patients who referred to Alzahra hospital in 2016
Public title
Study of the effect of phenol peeling blephroplasty for the periocular rejuvenation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age over 40 years; skin type : Fitzpatrick I-III; skin thickness : thin to medium; periorbitally scattered wrinkles; upper eyelid medial or lateral mild- to- medium Ptosis and informed Satisfaction to participate in the study Exclusion criteria: previous local treatment; patients dissatisfaction.
Age
From 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 20
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 Isfahan University of Medical Sciences
Street address
Deputy of research of Isfahan University of Medical Sciences, Hezar jerib Avenue, Isfahan.
City
Isfahan
Postal code
Approval date
2016-05-04, 1395/02/15
Ethics committee reference number
IR.MUI.REC.1395.3.301

Health conditions studied

1

Description of health condition studied
Blepharochalasis
ICD-10 code
H02.3
ICD-10 code description
Blepharochalasis

Primary outcomes

1

Description
rate of the patient's satisfaction for eyelid prolapse
Timepoint
two months after operation
Method of measurement
questionnaire

2

Description
rate of the patient's satisfaction for symmetry
Timepoint
two months after operation
Method of measurement
questionnaire

3

Description
rate of the physician's satisfaction with the upper eyelid flaccidity decrease
Timepoint
two months after operation
Method of measurement
observation

4

Description
rate of the patient's satisfaction for esthetics
Timepoint
two months after operation
Method of measurement
questionnaire

5

Description
rate of the patient's general satisfaction
Timepoint
two months after operation
Method of measurement
questionnaire

Secondary outcomes

1

Description
periorbital erythema
Timepoint
daily up to one week and then 2 weeks and 2 months after treatment start
Method of measurement
Visit, history and physical examination

2

Description
hypopigmentation
Timepoint
daily up to one week and then 2 weeks and 2 months after treatment start
Method of measurement
Visit, history and physical examination

3

Description
hyperpigmentation
Timepoint
daily up to one week and then 2 weeks and 2 months after treatment start
Method of measurement
Visit, history and physical examination

4

Description
scar
Timepoint
daily up to one week and then 2 weeks and 2 months after treatment start
Method of measurement
Visit, history and physical examination

5

Description
hematoma
Timepoint
daily up to one week and then 2 weeks and 2 months after treatment start
Method of measurement
Visit, history and physical examination

6

Description
granuloma
Timepoint
daily up to one week and then 2 weeks and 2 months after treatment start
Method of measurement
Visit, history and physical examination

7

Description
infection
Timepoint
daily up to one week and then 2 weeks and 2 months after treatment start
Method of measurement
Visit, history and physical examination

8

Description
dry eye syndrome
Timepoint
daily up to one week and then 2 weeks and 2 months after treatment start
Method of measurement
Visit, history and physical examination

9

Description
edema
Timepoint
daily up to one week and then 2 weeks and 2 months after treatment start
Method of measurement
Visit, history and physical examination

10

Description
bruising
Timepoint
daily up to one week and then 2 weeks and 2 months after treatment start
Method of measurement
Visit, history and physical examination

11

Description
loss of vision
Timepoint
daily up to one week and then 2 weeks and 2 months after treatment start
Method of measurement
Visit, history and physical examination

12

Description
diplopia
Timepoint
daily up to one week and then 2 weeks and 2 months after treatment start
Method of measurement
Visit, history and physical examination

13

Description
lagophtalmos
Timepoint
daily up to one week and then 2 weeks and 2 months after treatment start
Method of measurement
Visit, history and physical examination

14

Description
asymmetry
Timepoint
daily up to one week and then 2 weeks and 2 months after treatment start
Method of measurement
Visit, history and physical examination

15

Description
ptosis
Timepoint
daily up to one week and then 2 weeks and 2 months after treatment start
Method of measurement
Visit, history and physical examination

16

Description
pain
Timepoint
daily up to one week and then 2 weeks and 2 months after treatment start
Method of measurement
Visit, history and physical examination

Intervention groups

1

Description
After cleaning the face and injecting the local anesthetic in the upper eyelid region in the blepharopeeling group, peeling is performed in all the periocular region using phenol 89% and a cotton applicator until a white layer is formed. With a pair of iris scissors then, depending on the patient's skin thickness , 5-20 scissors cuts , each 3-5 mm wide, are performed in a network model in the upper eyelid.the cuts are not sutured . they are however spontaneously epithelialized instead.
Category
Treatment - Surgery

2

Description
After injecting the local anesthetic in the blepharoplasty group, the cuts are suprtficially performed with surgery blade NO.15 through the epiderm of the skin which have previously been marked are taken off. Hemostasis is performed with a cauter and the fats are taken out and cauterized and the wound is sutured.
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Isfahan Al Zahra Hospital
Full name of responsible person
Dr Behzad Bafandeh
Street address
Department of dermatology, Al Zahra Hospital , Soffeh Blvd
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Deputy of research of Isfahan University of Medical Sciences
Full name of responsible person
Dr Mehdi Nemat bakhsh
Street address
Deputy of research of Isfahan University of Medical Sciences, Hezar jerib Avenue, Isfahan.
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of research of Isfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Isfahan University of Medical Science
Full name of responsible person
Dr Behzad Bafandeh
Position
resident of dermatology
Other areas of specialty/work
Street address
Department of dermatology, Al Zahra Hospital , Soffeh Blvd
City
Isfahan
Postal code
Phone
+98 31 3668 5555
Fax
Email
b.bafandeh@resident.mui.ac.irbehzad.bafandeh@gmail.combehzad_bafandeh@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan University of Medical Science _ Skin disease and Leishmaniasis Research Center, Isfahan Univ
Full name of responsible person
Dr Ali Asillian
Position
professor
Other areas of specialty/work
Street address
Department of dermatology, Al Zahra Hospital , Soffeh Blvd
City
Isfahan
Postal code
Phone
+98 31 3620 2020
Fax
Email
asillian@med.mui.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Department of dermatology, Al Zahra Hospital , Soffeh Blvd
Full name of responsible person
Dr Behzad Bafandeh
Position
resident of dermatology
Other areas of specialty/work
Street address
Department of dermatology, Al Zahra Hospital , Soffeh Blvd
City
Isfahan
Postal code
Phone
+98 31 3620 2020
Fax
Email
b.bafandeh@resident.mui.ac.irbehzad.bafandeh@gmail.combehzad_bafandeh@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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