In this study, the researcher investigates the type of flap and non-healing of Platysma scar severity.
Design
A randomized controlled clinical trial with parallel, double-blind, randomized groups
Settings and conduct
Surgery was performed at Alzahra and Imam Reza hospitals in Isfahan.In group A patients, however, a platysma flap and flap repair were performed. In group B patients with platysma flap and without platysma repair are used, in group C patients with subcutaneous flap and with platysma repair used, in group D patients with flap Subcutaneously and without the platysma muscle repair used to remove the thyroid. These four groups were then compared and evaluated according to Vancouver scar score and patient satisfaction with patients' scar beauty during a 6-month follow-up.
Participants/Inclusion and exclusion criteria
•Inclusion criteria: Candidate for Thyroidectomy due to Thyroid Cancer (Modular, Papillary, Follicular and Anaplastic Types); Having a platelet count of 150-450,000 ppm
• Exclusion criteria:The site of the surgical incision to be manipulated during the study;Patients with a neck mass above 200 g;Patients with unsatisfactory or inadequate documentation;Patients who have a wound infection;No neuromuscular disorders of the neck such as neck spasm, diabetes mellitus (due to delayed wound healing).
Intervention groups
In group A patients, however, a platysma flap and flap repair were performed. In group B patients with platysma flap and without platysma repair are used, in group C patients with subcutaneous flap and with platysma repair used, in group D patients with flap Subcutaneously and without the platysma muscle repair used to remove the thyroid
Comparison of scar of Collar incision in thyroid surgery in the under and over platysma and repair Platysma in patients with thyroidectomy
Public title
Comparison of cutaneous scar of thyroid surgery flaps
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Candidate for Total Thyroidectomy for Thyroid Cancer (Modular, Papillary, Follicular and Anaplastic Types)
Platelet count of 150-450 thousand ppm
Exclusion criteria:
The site of the surgical incision to be manipulated during the study
Patients with a neck mass above 200 g
Patients with unsatisfactory or inadequate documentation
Patients who had a wound infection.
No neuromuscular disorders of the neck such as neck spasm, diabetes mellitus (due to delayed wound healing)
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
331
Actual sample size reached:
160
Randomization (investigator's opinion)
Randomized
Randomization description
Random block
Blinding (investigator's opinion)
Double blinded
Blinding description
Nursing ward and physician evaluating wound scar and analyzing data were not aware of the type of surgery and technique performed
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
Isfahan University of Medical Sciences, Hezar Jarib St
City
Isfahan
Province
Isfehan
Postal code
73461-81746
Approval date
2017-05-03, 1396/02/13
Ethics committee reference number
395984 ( در سال 1396 توسط دانشگاه علوم پزشکی اصفهان تصویب شده است)
Health conditions studied
1
Description of health condition studied
Thyroid Cancer
ICD-10 code
C73
ICD-10 code description
Malignant neoplasm of thyroid gland
Primary outcomes
1
Description
Flexibility, perfusion, pigmentation and scar thickness
Timepoint
Second day and first month and sixth month
Method of measurement
Vancouver Scar Scaling
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Platysma muscle flap formation and platysma muscle repair
Category
Treatment - Surgery
2
Description
Intervention group: Creating a platysma muscle flap without repairing the platysma muscle
Category
Treatment - Surgery
3
Description
Intervention group: Subcutaneous flap formation and platysma repair
Category
Treatment - Surgery
4
Description
Intervention group: Create a subcutaneous flap without repairing the platysma
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Dr Mohsen Kolahdouzan
Street address
Al-Zahra Medical Training Center, Sofeh Boulevard
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Fax
Email
Alzahra@mui.ac.ir
Web page address
http://Alzahra.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Mohsen Kolahdouzan
Street address
Unit 219, Physician Residential Complex, Moshtaq Third St
City
Isfahan
Province
Isfehan
Postal code
815894433
Phone
+98 31 3620 1293
Email
Kolahdouzan@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Ali Akhavan
Position
Resident of General surgery
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
No. 284, Padideh Abshar Counseling Center, Abshar II St
City
Isfahan
Province
Isfehan
Postal code
8166664433
Phone
+98 31 3630 7204
Email
Dr.akhavan@live.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Mohsen Kolahdouzan
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Unit 219, Physician Residential Complex, Moshtaq Third St
City
Isfahan
Province
Isfehan
Postal code
815894433
Phone
+98 31 3620 1293
Email
Kolahdouzan@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ali Akhavan
Position
Resident of General surgery
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
No. 284, Padideh Abshar Counseling Center, Abshar II St
City
Isfahan
Province
Isfehan
Postal code
8166664433
Phone
+98 31 3630 7204
Email
Dr.akhavan@live.com
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