Phase
Condition
N/ATreatment
Surgical implantation of the PCL Breast scaffold with autologous fat grafting
Clinical Study ID
Ages > 18 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Females over the age of 18 requiring pre-pectoral breast implant revision orcongenital defect correction surgery, unilateral or bilateral.
Patient willing and able to comply with the study requirements.
Patient is eligible to undergo MRI (i.e., no implanted incompatible metal or metaldevices, no history of severe claustrophobia).
Patient capable of providing valid informed consent.
Patient has sufficient body fat for homologous transplantation.
Exclusion
Exclusion Criteria:
Patients who have undergone Radical Mastectomy or radical removal of chest wall softtissue.
Patients who have had breast or chest wall irradiation.
Prior history of infection in the breast region in the preceding 12 months.
Patients diagnosed with or having a prior history of Breast Implant-AssociatedAnaplastic Large Cell Lymphoma (BIA-ALCL).
The patient has any condition or disease, including uncontrolled diabetes (e.g.,HbA1c > 8%), that is clinically known to impact wound healing ability.
Patient with a known history of immunodeficiency including HIV, concomitant systemiccorticosteroid therapy, chemotherapy, synchronous haematological malignancy or othercause for secondary/primary immunodeficiency.
Known severe concurrent or inter-current illness including cardiovascular,respiratory or immunological illness, psychiatric disorders, alcohol or chemicaldependence, possible allergies that would, in the opinion of the Co-ordinatingPrincipal Investigator, compromise their safety or compliance or interfere withinterpretation of study results.
Body mass Index (BMI) below 20 and above 30 (patients with a BMI above 30 may stillbe eligible pending assessment by investigating team and documentation ofrationale).
Polycaprolactone (PCL) allergy
Women who are currently pregnant or breast feeding, or who are planning to becomepregnant within two years after the breast surgery.
Patient ineligible to undergo MRI.
Patient unable or unwilling to comply with the treatment protocol.
Patient unwilling or unable to provide fully informed consent including but notlimited to patients with intellectual or mental impairment.
Patients with a history of smoking (patients with a history of smoking may still beeligible pending assessment by investigating team and documentation of rationale)
Study Design
Study Description
Connect with a study center
Royal Brisbane and Women's Hospital (RBWH)
Brisbane, Queensland QLD 4029
AustraliaSite Not Available
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.