A comparative clinical study of scars of surgical incisions between Monocryl versus Prolene (4-0) sutures for closing the outermost layer in mammoplasty
The aim of this study was to detect the superior suture material for Mammoplasty among Polypropylene and Monocryl, based on the comparison of the scars.
Design
Clinical trials for intervention, community-based and action-oriented, parallel group, double-blind
Settings and conduct
This study was carried out double-blind in Ghaem Hospital. The patient and doctor did not know which yarn was used on any side. The only person who knows which treatment is assigned to the left and right breast is the assistant professor of plastic surgery who has been collecting the analyst's information.
Participants/Inclusion and exclusion criteria
This clinical trial study was performed on 78 patients referred to surgery department of Ghaem Hospital during who were candidates for plastic mammoplasty surgery and patients were excluded for the following reasons: diabetes mellitus; anemia and hypertension because these disease affected on wound healing.
Intervention groups
Plastic surgery with Monocryl versus Prolene (4-0) sutures
Main outcome variables
Vancouver score; rate of infection and complications after surgery
General information
Reason for update
Acronym
-
IRCT registration information
IRCT registration number:IRCT20171008036630N2
Registration date:2018-09-29, 1397/07/07
Registration timing:retrospective
Last update:2018-09-29, 1397/07/07
Update count:0
Registration date
2018-09-29, 1397/07/07
Registrant information
Name
Ezatollah Rezaei
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 915 110 6392
Email address
rezaeie@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2015-09-21, 1394/06/30
Expected recruitment end date
2017-09-21, 1396/06/30
Actual recruitment start date
2015-09-21, 1394/06/30
Actual recruitment end date
2017-12-21, 1396/09/30
Trial completion date
2018-09-06, 1397/06/15
Scientific title
A comparative clinical study of scars of surgical incisions between Monocryl versus Prolene (4-0) sutures for closing the outermost layer in mammoplasty
Public title
A comparative clinical study of scars of surgical incisions between absorbed and non-absorbed sutures for closing the outermost layer in mammoplasty
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients who were candidates for mammoplasty plastic surgery
Exclusion criteria:
Anemia
Diabetes mellitus
Hypertension
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
78
Actual sample size reached:
78
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
This study was conducted double-blind. The general practitioner and the physician were not aware of which side was used on any of the threads. The only person who knows which treatment is assigned to the left and right breast is the assistant professor of plastic surgery who has been collecting the analyst's information.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
scientific committee and the institutional review board of Mashhad university of medical sciences
Street address
َAhmad Abad street
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Approval date
2018-01-20, 1396/10/30
Ethics committee reference number
IR.MUMS.fm.REC.1395.654
Health conditions studied
1
Description of health condition studied
Scars of surgical incisions
ICD-10 code
L00-L08
ICD-10 code description
Infections of the skin and subcutaneous tissue
Primary outcomes
1
Description
Repair of the skin after surgery
Timepoint
The first week, 1 and 3 months later
Method of measurement
Observer Scar Assessment (POSAS) criteria.
2
Description
The amount of inflammation of the wound
Timepoint
The first week, 1 and 3 months later
Method of measurement
Observer Scar Assessment (POSAS) criteria
3
Description
The degree of itching of the wound
Timepoint
The first week, 1 and 3 months later
Method of measurement
Observer Scar Assessment (POSAS) criteria.
Secondary outcomes
1
Description
satisfaction of patient
Timepoint
3 months after surgery
Method of measurement
based on Likert scale
Intervention groups
1
Description
Intervention group: One breast of all patients treated with Monocryl (absorbable sutures catgut sutures 0-4 Weco Inc., China).Then patients are followed in the days and months mentioned (first week, 1 and 3 months later) and the photographer is done. All patients had a follow-up visit by two plastic surgeon blinded to the patient’s study using Patient and Observer Scar Assessment Scale (POSAS) for one week , 1 and 3 months after the initial repair
Category
Treatment - Surgery
2
Description
Intervention group 2: other breast received polypropylene (nonabsorbable sutures 0-4 Weco Inc., China). Then patients are followed in the days and months mentioned (first week, 1 and 3 months later) and the photographer is done. All patients had a follow-up visit by two plastic surgeon blinded to the patient’s study using Patient and Observer Scar Assessment Scale (POSAS) for one week , 1 and 3 months after the initial repair
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem haspital
Full name of responsible person
Ezatollah Rezaei
Street address
Ahmad Abad street
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 3801 2841
Fax
+98 51 3843 6199
Email
rezaeie@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Ezatollah Rezaei
Street address
Ahmad Abad street
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 3801 2841
Fax
+98 51 3843 6199
Email
rezaeie@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Ezatollah Rezaei
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Ahmad abad street
City
mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 3801 2840
Email
rezaeie@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Ezatollah Rezaei
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Ahmad abad street
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 3843 6199
Email
rezaeie@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Ezatollah Rezaei
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Ahmad abad street
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 3801 2841
Email
rezaeie@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information
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