NCT02263261

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2015

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 6, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 13, 2014

Completed
5 months until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

September 20, 2018

Status Verified

March 1, 2015

Enrollment Period

1.3 years

First QC Date

October 6, 2014

Last Update Submit

September 18, 2018

Conditions

MastectomyBreast Reconstruction

Keywords

dermal matrix

Outcome Measures

Primary Outcomes (1)

  • 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 (2)

  • Aesthetic Outcomes

    6 months post reconstruction

  • Patient-Reported Outcomes

    6 months post reconstruction

Study Arms (1)

Flex HD Pliable Perforated HADM

OTHER

Single Arm

Other: Flex HD Pliable Perforated HADM

Interventions

Flex HD Pliable Perforated HADMOTHER

Human Acellular Dermal Matrix

Flex HD Pliable Perforated HADM

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • BMI \> 40
  • Previous Radiation Treatment. Note: Post-operative radiation treatment does not exclude subjects from study continuation once enrolled.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Liu Plastic surgery

Mountain View, California, 94040, United States

Location

Liu Plastic Surgery

San Jose, California, 95124, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2014

First Posted

October 13, 2014

Study Start

March 1, 2015

Primary Completion

June 1, 2016

Study Completion

November 1, 2016

Last Updated

September 20, 2018

Record last verified: 2015-03

Locations

US(2)