A Prospective, Randomized, Multi-Center Clinical Study Comparing Outcomes in Patients Undergoing Prosthetic, Acellular Dermal Matrix (ADM) Assisted, Immediate Post-Mastectomy Breast Reconstruction
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 224
- Locations
- 13
- Primary Endpoint
- Post Reconstruction Complication Rates
Study Overview
Brief Summary
Evaluation and comparison of clinical and aesthetic outcomes associated with the use of two allograft dermal matrices (ADMs) currently in use for tissue assisted immediate post-mastectomy breast reconstruction.
Detailed Description
This is a level one, prospective, randomized, controlled multi-center clinical study comparing two types of acellular dermal matrices (ADMs) currently used in immediate post-mastectomy prosthetic breast reconstruction. Comparison of these two ADMs will be made in the areas of reconstructive clinical outcomes and aesthetic outcomes. Patients will be randomized into one of two ADM groups as part of their immediate post-mastectomy breast reconstruction. Patients in both groups will be followed for twelve months after their reconstructive surgery. Clinical outcomes will be documented at 1 month, 3 months, 6 months and 12 months following breast reconstructive surgery. For one-stage breast reconstruction, aesthetic outcomes will be assessed and documented at 6 and 12 months following implant placement. For two-stage reconstruction, patients will be evaluated for aesthetic outcomes at a time point 6-12 months following expander-to-implant exchange if it does not coincide with the 12 month post-mastectomy visit.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
3-4 independent breast surgeons using predefined criteria will assess the aesthetic outcomes of each subject using photographs of their pre-mastectomy and 12 month post-reconstructions. The surgeons will not be apprised of the ADM type or post-mastectomy site/surgeon
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Scheduled to undergo immediate, post-mastectomy, tissue assisted breast reconstruction, Reconstruction shall be either one-stage (direct-to-implant) or two-stage, unilateral or bilateral, prophylactic or therapeutic
- •Females at least 18 years of age
- •Non-smokers, former smokers and/or smokers who have not smoked within 1 month before surgery, and who agree to not smoke or utilize e-cigarettes during the post-operative period
- •Have signed a written informed consent
- •Have the ability to understand and comply with the requirements and follow-up time points of the study
Exclusion Criteria
- •Previous breast surgery with the exception of biopsy
- •Previous radiation treatment in either breast at any time
- •Undergoing autologous breast reconstruction
- •Pre-pectoral implant placement
- •Undergoing delayed reconstruction
- •Requiring Wise pattern reduction of mastectomy skin flap
- •History of chronic steroid use within the past 6 months
- •History of HIV positive
- •Previous organ transplant
- •Pregnant or lactating females
- •Clinically significant systemic disease, as determined by the investigator, which could affect study participation or study results
Arms & Interventions
Cohort A
FlexHD ADM
Intervention: FlexHD ADM (Cohort A) (Biological)
Cohort B
AlloDerm RTU ADM
Intervention: AlloDerm RTU ADM (Cohort B) (Biological)
Outcomes
Primary Outcomes
Post Reconstruction Complication Rates
Time Frame: 12 months
To compare the overall complication rate between the cohorts defined as either 1) post-operative infection specific to the reconstructed breast(s) requiring either intravenous antibiotic treatment or operative intervention, 2) seroma, and/or 3) reconstructive failure
Secondary Outcomes
- Comparison of Each Complication Rate(12 months)
- Comparison of Aesthetic Outcomes (Photographs)(12 months)