Reconstructive, Aesthetic and Patient Reported Outcomes Associated With the Use of Flex HD Pliable, Perforated Human Acellular Dermal Matrix in Implant-Based Breast Reconstruction: A Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- Types and incidence of complications
Study Overview
Brief Summary
Use of a HADM and implant in post-mastectomy breast reconstruction.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Flex HD Pliable Perforated HADM
Single Arm
Intervention: Flex HD Pliable Perforated HADM (Other)
Outcomes
Primary Outcomes
Types and incidence of complications
Time Frame: 6 months post reconstruction
Documentaiton of any medical and/or surgical problem requiring treatment that arises as a result of the reconstruction procedure
Secondary Outcomes
- Aesthetic Outcomes(6 months post reconstruction)
- Patient-Reported Outcomes(6 months post reconstruction)