Reconstruction Outcomes in Immediate Post-mastectomy Breast Reconstruction With ADM

Breast Reconstruction Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03145337
• Other study ID #: MTF 16-04-01
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 1, 2017
• Est. completion date: May 2019

Study information

• Verified date: May 2018
• Source: Musculoskeletal Transplant Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 224
• Est. completion date: May 2019
• Est. primary completion date: February 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Reconstruction

Intervention

Biological:
• FlexHD ADM (Cohort A)
Tissue assisted breast reconstruction with FlexHD pliable perforated ADM
• AlloDerm RTU ADM (Cohort B)
Tissue assisted breast reconstruction with AlloDerm RTU perforated ADM

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Northwestern University Medical Center	Chicago	Illinois
United States	NorthShore Health Systems	Evanston	Illinois
United States	Harris Methodist Southlake Hospital	Fort Worth	Texas
United States	Faulkner Brigham & Women's Hospital	Jamaica Plain	Massachusetts
United States	Louisiana State Health Science Center	New Orleans	Louisiana
United States	New York University Langone Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Musculoskeletal Transplant Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Comparison of Aesthetic Outcomes (Photographs)	A blinded comparison of aesthetic outcomes (photographs) using pre-defined criteria	12 months