Breast Reshaping Following Massive Weight Loss

NCT06262724 | Completed

• 1 other identifier: Perforator Flaps
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Reliability of Chest Wall Perforator Flaps for Breast Reshaping following Massive Weight Loss

Conditions

Breast Ptosis

Outcome Measures

Primary Outcomes (1)

• Measurement of breast volume by sono-mammography

  Use of sono-mammography to measure the breast volume in cubic centimetres preoperatively, after 6 months and after one year following surgery. The equation used to measure the breast volume was as follows: Breast volume = π/4 × (W × H × C) where W = breast width, H = breast height, and C=compression thickness in craniocaudal mammography)

  One year follow-up

Secondary Outcomes (3)

• Sternal notch to nipple distance

  One-year follow-up

• Nipple to inframammary fold distance

  One-year follow-up

• Measure of nipple-to-nipple distance

  One-year follow-up

Study Arms (1)

Surgery

OTHER

Surgical intervention for breast reshaping utilizing chest wall perforators for auto-augmentation.

Procedure: Breast auto-augmentation

Interventions

Breast auto-augmentation PROCEDURE

Single group assignment. All patients included were subjected to utilizing chest wall perforator flaps for breast reshaping.

Surgery

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age: 18-45 years old.
• Weight:
• Loss of 50% or greater of excess weight, following surgical or non-surgical interventions (MWL).
• Stable weight for at least 6 months, to achieve metabolic and nutritional homeostasis and decrease the risk of surgical complications (Rubin et al., 2004).
• BMI: 18.5 - 30 kg/m2.
• Ptotic and deflated breasts with Pittsburgh Rating Scale (PRS) score 2-3 (Song, et al., 2005).
• Patients seeking autologous augmentation or refusing implants.
• Patients requiring simultaneous contouring of lateral chest wall redundancy.

You may not qualify if:

• Weight fluctuations in the previous 6 months.
• Medical co-morbidities (e.g., uncontrolled diabetes, uncontrolled hypertension, thyroid diseases, hormonal disturbances, cardiopulmonary diseases).
• Hereditary conditions that affect wound healing (e.g., Ehler Danlos Syndrome, Progeria).
• Active smokers (Smokers are required to stop smoking 1 month before surgery).
• Nutritional deficiencies (e.g., iron, vitamin B12, protein, folate).
• Previous breast surgery.
• Congenital breast deformity (e.g., tuberous breasts).
• Breast masses.
• Pregnant or lactating patients.
• PRS score 1.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of Medicine, Ain Shams University

Cairo, Abbasia, 11591, Egypt

Location

Study Officials

• Amr AW Mabrouk, MD

  Faculty of Medicine, Ain Shams University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All patients were subjected to the same intervention.

Study Record Dates

• First Submitted: January 22, 2024
• First Posted: February 16, 2024
• Study Start: August 1, 2021
• Primary Completion: August 1, 2023
• Study Completion: January 1, 2024
• Last Updated: February 26, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)