Reconstruction Outcomes in Immediate Post-mastectomy Breast Reconstruction With ADM

A Prospective, Randomized, Multi-Center Clinical Study Comparing Outcomes in Patients Undergoing Prosthetic, Acellular Dermal Matrix (ADM) Assisted, Immediate Post-Mastectomy Breast Reconstruction

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.

Study Overview

• Status: Unknown
• Conditions: Breast Reconstruction
• Intervention / Treatment: Biological: FlexHD ADM (Cohort A); Biological: AlloDerm RTU ADM (Cohort B)

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 Type: Interventional
• Enrollment (Anticipated): 224
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University Medical Center
    • Evanston, Illinois, United States, 60062
      • NorthShore Health Systems
  • Louisiana
    • New Orleans, Louisiana, United States, 70115
      • Louisiana State Health Science Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Jamaica Plain, Massachusetts, United States, 02130
      • Faulkner Brigham & Women's Hospital
  • New York
    • New York, New York, United States, 10017
      • New York University Langone Medical Center
  • Texas
    • Fort Worth, Texas, United States, 76104
      • Harris Methodist Southlake Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Cohort A; FlexHD ADM	Biological: FlexHD ADM (Cohort A); Tissue assisted breast reconstruction with FlexHD pliable perforated ADM; Other Names: FlexHD ADM
Active Comparator: Cohort B; AlloDerm RTU ADM	Biological: AlloDerm RTU ADM (Cohort B); Tissue assisted breast reconstruction with AlloDerm RTU perforated ADM; Other Names: AlloDerm RTU ADM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post Reconstruction Complication Rates	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	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of Each Complication Rate	To compare each complication rate between the cohorts defined as 1) post-operative infection specific to the reconstructed breast(s) requiring either intravenous antibiotic treatment or operative intervention 20 seroma 3) reconstructive failure and 4) reoperation for reasons other than infection	12 months
Comparison of Aesthetic Outcomes (Photographs)	A blinded comparison of aesthetic outcomes (photographs) using pre-defined criteria	12 months

Collaborators and Investigators

• Sponsor: Musculoskeletal Transplant Foundation

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2017
• Primary Completion (Anticipated): February 1, 2019
• Study Completion (Anticipated): May 1, 2019

Study Registration Dates

• First Submitted: May 3, 2017
• First Submitted That Met QC Criteria: May 8, 2017
• First Posted (Actual): May 9, 2017

Study Record Updates

• Last Update Posted (Actual): September 19, 2018
• Last Update Submitted That Met QC Criteria: September 18, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: MTF 16-04-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No