Breast Ptosis Clinical Trial
Official title:
Reliability of Chest Wall Perforator Flaps for Breast Reshaping Following Massive Weight Loss
Verified date | February 2024 |
Source | Ain Shams University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Reliability of Chest Wall Perforator Flaps for Breast Reshaping following Massive Weight Loss
Status | Completed |
Enrollment | 20 |
Est. completion date | January 1, 2024 |
Est. primary completion date | August 1, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Egypt | Faculty of Medicine, Ain Shams University | Cairo | Abbasia |
Lead Sponsor | Collaborator |
---|---|
Ain Shams University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 = p/4 × (W × H × C) where W = breast width, H = breast height, and C=compression thickness in craniocaudal mammography) |
One year follow-up | |
Secondary | Sternal notch to nipple distance | Measures of the distance between sternal notch and nipple in centimetres in both sides using tape preoperatively, after 6 months and one year following surgery | One-year follow-up | |
Secondary | Nipple to inframammary fold distance | Measures of the distance between nipple and intramammary fold in centimetres in both sides using tape preoperatively, after 6 months and one year following surgery | One-year follow-up | |
Secondary | Measure of nipple-to-nipple distance | Measure of the distance between both nipples in centimetres using tape preoperatively, after 6 months and one year following surgery | One-year follow-up |
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