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Reconstruction Outcomes in Immediate Post-mastectomy Breast Reconstruction With ADM

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ClinicalTrials.gov Identifier: NCT03145337
Recruitment Status : Active, not recruiting
First Posted : May 9, 2017
Last Update Posted : September 19, 2018
Sponsor:
Information provided by (Responsible Party):
Musculoskeletal Transplant Foundation

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.

Condition or disease Intervention/treatment Phase
Breast Reconstruction Biological: FlexHD ADM (Cohort A) Biological: AlloDerm RTU ADM (Cohort B) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 224 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, randomized, controlled
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
Primary Purpose: Treatment
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
Actual Study Start Date : July 1, 2017
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Cohort A
FlexHD ADM
Biological: FlexHD ADM (Cohort A)
Tissue assisted breast reconstruction with FlexHD pliable perforated ADM
Other Name: 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 Name: AlloDerm RTU ADM




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Comparison of Each Complication Rate [ Time Frame: 12 months ]
    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

  2. Comparison of Aesthetic Outcomes (Photographs) [ Time Frame: 12 months ]
    A blinded comparison of aesthetic outcomes (photographs) using pre-defined criteria



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03145337


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

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Responsible Party: Musculoskeletal Transplant Foundation
ClinicalTrials.gov Identifier: NCT03145337     History of Changes
Other Study ID Numbers: MTF 16-04-01
First Posted: May 9, 2017    Key Record Dates
Last Update Posted: September 19, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No