Clinical trial NCT03145337: Reconstruction Outcomes in Immediate Post-mastectomy Breast Reconstruction With ADM
Official title: A Prospective, Randomized, Multi-Center Clinical Study Comparing Outcomes in Patients Undergoing Prosthetic, Acellular Dermal Matrix (ADM) Assisted, Immediate Post-Mastectomy Breast Reconstruction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Reconstruction
Lead sponsor: Musculoskeletal Transplant Foundation
Sponsor class: OTHER
First posted: 2017-05-09
Enrollment: 224
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, randomized, controlled
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. 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
2. Females at least 18 years of age
3. 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
4. Have signed a written informed consent
5. Have the ability to understand and comply with the requirements and follow-up time points of the study

Exclusion Criteria:

1. Previous breast surgery with the exception of biopsy
2. Previous radiation treatment in either breast at any time
3. Undergoing autologous breast reconstruction
4. Pre-pectoral implant placement
5. Undergoing delayed reconstruction
6. Requiring Wise pattern reduction of mastectomy skin flap
7. History of chronic steroid use within the past 6 months
8. History of HIV positive
9. Previous organ transplant
10. Pregnant or lactating females
11. Clinically significant systemic disease, as determined by the investigator, which could affect study participation or study results

Primary outcomes:
measure: Post Reconstruction Complication Rates
timeFrame: 12 months
Secondary outcomes:
measure: Comparison of Each Complication Rate
timeFrame: 12 months
measure: Comparison of Aesthetic Outcomes (Photographs)
timeFrame: 12 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University Medical Center
state: Illinois
city: Evanston
country: United States
facility: NorthShore Health Systems
state: Illinois
city: New Orleans
country: United States
facility: Louisiana State Health Science Center
state: Louisiana
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Jamaica Plain
country: United States
facility: Faulkner Brigham & Women's Hospital
state: Massachusetts
city: New York
country: United States
facility: New York University Langone Medical Center
state: New York
city: Fort Worth
country: United States
facility: Harris Methodist Southlake Hospital
state: Texas
Study officials:
References: