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IRCT20171008036630N2 IRCT 2018-09-29 Mashhad University of Medical Sciences A comparative clinical study of scars of surgical incisions between absorbed and non-absorbed sutures for closing the outermost layer in mammoplasty - A comparative clinical study of scars of surgical incisions between Monocryl versus Prolene (4-0) sutures for closing the outermost layer in mammoplasty 2015-09-21 anticipated 78 Complete https://irct.ir/trial/33670 interventional Randomization: Not randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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. N/A Scars of surgical incisions. Intervention 1: 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. Intervention 2: 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. No - There is not a plan to make this available Justification or reason for not sharing IPD is No more information
public Ezatollah Rezaei
Ahmad abad street
mashhad Iran (Islamic Republic of) 9177899191 +98 51 3801 2840 rezaeie@mums.ac.ir Mashhad University of Medical Sciences scientific Ezatollah Rezaei
Ahmad abad street
Mashhad Iran (Islamic Republic of) 9177899191 +98 51 3843 6199 rezaeie@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) All patients who were candidates for mammoplasty plastic surgery no limit no limit Female Anemia Diabetes mellitus Hypertension L00-L08 Infections of the skin and subcutaneous tissue Treatment - Surgery Treatment - Surgery 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 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 Repair of the skin after surgery. Timepoint: The first week, 1 and 3 months later. Method of measurement: Observer Scar Assessment (POSAS) criteria. The amount of inflammation of the wound. Timepoint: The first week, 1 and 3 months later. Method of measurement: Observer Scar Assessment (POSAS) criteria. The degree of itching of the wound. Timepoint: The first week, 1 and 3 months later. Method of measurement: Observer Scar Assessment (POSAS) criteria. Satisfaction of patient. Timepoint: 3 months after surgery. Method of measurement: based on Likert scale. Mashhad University of Medical Sciences Approved 2018-01-20 scientific committee and the institutional review board of Mashhad university of medical sciences َAhmad Abad street Mashhad Razavi Khorasan Iran (Islamic Republic of)