Evaluation of a Human Acellular Dermal Matrix in Post Mastectomy Reconstruction

MTF Biologics

Status

Completed

Conditions

Breast Reconstruction

Mastectomy

Treatments

Other: Flex HD Pliable Perforated HADM

Study type

Interventional

Funder types

Other

Identifiers

NCT02263261

MTF 13-03

Details and patient eligibility

About

Use of a HADM and implant in post-mastectomy breast reconstruction.

Full description

This is a prospective, single-site pilot study in which outcomes associated with the use of Flex HD® Pliable™ Perforated, Human Acellular Dermal Matrix and an implant which are used in post-mastectomy breast reconstruction will be obtained. The data collected will include reconstructive outcomes, aesthetic outcomes and patient-reported outcomes in order to ascertain advantages and disadvantages of using this particular HADM in post-mastectomy breast reconstruction.

Enrollment

40 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Scheduled to undergo a single or two-stage, tissue-assisted, implant breast reconstruction
Mastectomy may be unilateral or bilateral, prophylactic or therapeutic
Skin incision may be skin sparing, or nipple-areolar sparing
Have signed written, informed consent
Be at least 18 years of age

Exclusion criteria

Patients undergoing autologous breast reconstruction
Patients undergoing breast reconstruction following complications of breast augmentation, mastopexy, breast reduction, or breast conservation surgery (lumpectomy)
Patients undergoing reconstruction after previously failed attempts at reconstruction
Patients undergoing autologous breast reconstruction in conjunction with a tissue expander (such as a latissimus dorsi flap, DIEP flap)
There will be no exclusions based on race or ethnicity
BMI > 40
Previous Radiation Treatment. Note: Post-operative radiation treatment does not exclude subjects from study continuation once enrolled.