An Observational Study Exploring the Esthetic Outcomes of Breast Reduction Surgery and /or Mastopexy

Terminated

• Conditions: Macromastia

• Registration Number: NCT02016677
• Lead Sponsor: Orbix Medical Ltd.

Brief Summary

The purpose of the study is to collect data regarding the aesthetic outcomes of patients who had breast reduction surgery and /or mastopexy in terms such as scaring, patient satisfaction, breast ptosis assessment including taking photographs and filling questionnaires.

Detailed Description

This is a prospective observational study, single center cohort to explore the aesthetic outcomes of patients who had breast reduction and / or mastopxy surgery. The surgical intervention will be determined by the clinician with no correlation to this study.

The study will focus on the aesthetic aspects of the clinical outcome resultant from the breast surgery in par course of 5 years. Scar tissue assessment and patient's reported data (satisfaction and well-being) will be collected.

Suitable patients will be assessed for study eligibility at a screening visit and, if eligible, will be scheduled for breast surgery according to the patient and surgeon discretion.

At each follow up visit, patients will undergo clinical general examination, breast and ptosis endearments, scar appearance , aesthetic evaluation. Patients will fill satisfaction questionnaires

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2013-12-10
• Study First Submitted QC: 2013-12-15
• Study First Posted: 2013-12-20
• Status Verified: 2015-10
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Last Update Submitted: 2015-12-22
• Last Update Posted: 2015-12-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 5

Inclusion Criteria

1. Female patient older than 30 years of age.
2. Patients willing to participate as evidenced by signing the written informed consent.
3. Patient that was found by her physician illegible for breast reduction surgery and /or mastopxy

Exclusion Criteria

1. Active psychiatric illness, cognitive or sensory impairment. 2. Physical impairment that may prevent filling out a paper and pencil survey or responding to interview questions

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Measuring the aesthetic outcomes of pre /post- surgical breast ptosis	during 5 years post- surgically	Breast measurements consists on: * Breast cup size; * Distortions or skin retractions; * Symmetry between the two breasts; * Ptosis grade evaluated on the basis of an I-IV scale; * Methods to measure breast shape and symmetry; * Skin texture (soft or hard); * Skin consistency; * Nipple location on the breast mound scored on a scale of 1 - 5; * Areola diameter (mm); * The shape of the breast scored on a scale of 1 - 5; * Scar Appearance evaluation -VAS score; * Patient satisfaction questionnaires

Trial Locations

Locations (1)

The Plastic Surgery Department The Tel Aviv Sourasky Medical Center; 🇮🇱 Tel Aviv, Israel