Reconstruction Outcomes in Immediate Post-mastectomy Breast Reconstruction With ADM

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

224 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-01

Study Completion Date

2019-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Breast Reconstruction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective, randomized, controlled

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

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

Study Groups

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Cohort A

FlexHD ADM

Group Type ACTIVE_COMPARATOR

FlexHD ADM (Cohort A)

Intervention Type BIOLOGICAL

Tissue assisted breast reconstruction with FlexHD pliable perforated ADM

Cohort B

AlloDerm RTU ADM

Group Type ACTIVE_COMPARATOR

AlloDerm RTU ADM (Cohort B)

Intervention Type BIOLOGICAL

Tissue assisted breast reconstruction with AlloDerm RTU perforated ADM

Interventions

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FlexHD ADM (Cohort A)

Tissue assisted breast reconstruction with FlexHD pliable perforated ADM

Intervention Type BIOLOGICAL

AlloDerm RTU ADM (Cohort B)

Tissue assisted breast reconstruction with AlloDerm RTU perforated ADM

Intervention Type BIOLOGICAL

Other Intervention Names

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FlexHD ADM AlloDerm RTU ADM

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No