Evaluation of a Human Acellular Dermal Matrix in Post Mastectomy Reconstruction

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02263261

Enrollment

Registered

2014-10-13

Start date

2015-03-31

Completion date

2016-11-30

Last updated

2018-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Reconstruction, Mastectomy

Keywords

dermal matrix

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.

Interventions

OTHERFlex HD Pliable Perforated HADM

Human Acellular Dermal Matrix

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Types and incidence of complications	6 months post reconstruction	Documentaiton of any medical and/or surgical problem requiring treatment that arises as a result of the reconstruction procedure

Secondary

Measure	Time frame	Description
Aesthetic Outcomes	6 months post reconstruction	Aesthetic outcomes evaluated by the operating surgeon and two independent board certified plastic surgeons with breast reconstruction expertise
Patient-Reported Outcomes	6 months post reconstruction	Use of the Breast Q survey instrument

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026