Reconstruction Outcomes in Immediate Post-mastectomy Breast Reconstruction With ADM

Not Applicable

• Conditions: Breast Reconstruction
• Interventions: Biological: FlexHD ADM (Cohort A); Biological: AlloDerm RTU ADM (Cohort B)

• Registration Number: NCT03145337
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2017-05-03
• Study First Submitted QC: 2017-05-08
• Study First Posted: 2017-05-09
• Study Start: 2017-07-01
• Status Verified: 2018-05
• Last Update Submitted: 2018-09-18
• Last Update Posted: 2018-09-19
• Primary Completion: 2019-02
• Study Completion: 2019-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 224

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort A	FlexHD ADM (Cohort A)	FlexHD ADM
Cohort B	AlloDerm RTU ADM (Cohort B)	AlloDerm RTU ADM

Primary Outcome Measures

Name	Time	Method
Post Reconstruction Complication Rates	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

Name	Time	Method
Comparison of Each Complication Rate	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
Comparison of Aesthetic Outcomes (Photographs)	12 months	A blinded comparison of aesthetic outcomes (photographs) using pre-defined criteria

Trial Locations

Locations (7)

Faulkner Brigham & Women's Hospital; 🇺🇸 Jamaica Plain, Massachusetts, United States

Northwestern University Medical Center; 🇺🇸 Chicago, Illinois, United States

Harris Methodist Southlake Hospital; 🇺🇸 Fort Worth, Texas, United States

NorthShore Health Systems; 🇺🇸 Evanston, Illinois, United States

New York University Langone Medical Center; 🇺🇸 New York, New York, United States

Louisiana State Health Science Center; 🇺🇸 New Orleans, Louisiana, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States