Evaluation of a Human Acellular Dermal Matrix in Post Mas... | NCT02263261

Studies
Evaluation of a Human Acellular Dermal Matrix in Post Mastectomy Reconstruction

NCT02263261

Sponsor

Musculoskeletal Transplant Foundation

Status

Completed

Last Update Posted

Sep 20, 2018Actual

Enrollment

40Actual

Phase

Not Applicable

Conditions

Mastectomy
Breast Reconstruction

Interventions

Flex HD Pliable Perforated HADM

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2015

Primary Completion Date

Jun 2016Actual

Completion Date

Nov 2016Actual

First Submitted Date

Oct 6, 2014

First Submission Date that Met QC Criteria

Oct 10, 2014

First Posted Date

Oct 13, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 18, 2018

Last Update Posted Date

Sep 20, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Flex HD Pliable Perforated HADM	Other	Single Arm	Other: Flex HD Pliable Perforated HADM

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Flex HD Pliable Perforated HADM	Other	Human Acellular Dermal Matrix	Flex HD Pliable Perforated HADM

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Aesthetic Outcomes	Aesthetic outcomes evaluated by the operating surgeon and two independent board certified plastic surgeons with breast reconstruction expertise	6 months post reconstruction
Patient-Reported Outcomes

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Liu Plastic surgery		Mountain View	California	94040	United States
Liu Plastic Surgery