Implant Based Breast Reconstruction
Conditions
Brief summary
Prospective, multi-center, single-arm clinical study in females undergoing immediate implant-based breast reconstruction using a pre-pectoral technique
Interventions
OTHERNo intervention
Historical Control Arm
DEVICEFlexHD® Pliable
Acellular Dermal Matrix
Sponsors
MCRA (an IQVIA business)
Bruder Consulting International, LLC
Musculoskeletal Transplant Foundation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Females at least 22 years of age * Scheduled to undergo unilateral or bilateral mastectomy with immediate implant-based, prepectoral breast reconstruction * Willing to provide Informed Consent * Able to return for all required study visits * Must read and understand English language
Exclusion criteria
* Is of childbearing potential and has a positive pregnancy test within 7 days of study procedure * Has a residual gross tumor at the intended reconstruction site * Has undergone previous breast surgery, such as lumpectomy or breast augmentation, at the site of implantation with the exception of a biopsy * Has undergone previous radiation therapy to the reconstruction site or chest wall, or is scheduled to undergo post-operative radiation therapy at the reconstruction site * Completed chemotherapy within 3 weeks prior to surgery * Has been diagnosed with a comorbid condition determined by the investigator to place the subject at an increased risk of complications * Has a Body Mass Index (BMI) \>35 * Has used nicotine products within 1 month of screening * Must not have taken oral corticosteroids for a minimum of 1 month prior to the procedure or have a history of long-term use of systemic oral corticosteroids or anticipate the use during course of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of major complication | 12 months | Complications that require additional hospitalization or reoperation |
| Frequency of reconstructive failure | 12 months | Removal/explantation of the breast implant |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in patient reported outcomes | 12 months | Change from baseline in patient reported outcomes as measured by the BREAST-Q (Scoring 0-100; 0=less satisfaction; 100= greater satisfaction) |
| Pain | 12 months | Pain scores as measured by the Numerical Pain Rating Scale (NPRS) (Scoring 0-10; 0=no pain; 10= worst imaginable pain) |
| Adverse events | 12 months | Reported adverse events |
Countries
United States
Outcome results
None listed