Reconstruction Outcomes in Immediate Post-mastectomy Breast Reconstruction With ADM

MTF Biologics

Status: Unknown

Conditions: Breast Reconstruction

Treatments: Biological: AlloDerm RTU ADM (Cohort B); Biological: FlexHD ADM (Cohort A)

Study type: Interventional

Funder types: Other

Identifiers

NCT03145337

MTF 16-04-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 224 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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224 participants in 2 patient groups

Cohort A

Active Comparator group

Description:

FlexHD ADM

Treatment:

Biological: FlexHD ADM (Cohort A)

Cohort B

Active Comparator group

Description:

AlloDerm RTU ADM

Treatment:

Biological: AlloDerm RTU ADM (Cohort B)