This phase III randomized clinical trial will compare direct-to-implant pre-pectoral breast reconstruction with different supportive materials:
the trial will comprise two arms: A-PRE-PECTORAL technique with a biological Acellular Dermal Matrix (ADM) prosthesis coverage and support + FAT GRAFTING VS B-PRE-PECTORAL technique with a synthetic Titanium Coated Polypropylene Mesh (TCPM) prosthesis coverage and support + FAT GRAFTING
Age
18–80
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
Nipple-sparing mastectomy NSM and skin-reducing mastectomy SRM)
Prophylactic and therapeutic.
Included patients baseline characteristics will be:
Age 18-80 years old
BMI between 18.5 and 35.
Former smokers (up until 3 weeks before surgery)
Hypertension at oral medications
Diabetes
Previous breast surgery
Previous breast and chest wall radiation therapy will be allowed.
You may not be if
T4 and metastatic breast cancers
Obese patients (BMI over 35)
Currently smoking patients (within 3 weeks before surgery)
Refusal to sign the consent
Severe comorbidities requiring a chronic therapy (renal failure, heart failure, cardiovascular diseases, pulmonary diseases, hepatic diseases, and metabolic diseases).
Clareo Health | Pre-pectoral Breast Reconstruction PART 1
