NCT02372305

Brief Summary

FlexHD and Alloderm are two common products used in breast reconstruction to hold tissue expanders and implants in place. There have been few chart review studies comparing outcomes between the two materials in breast reconstruction. These studies have determined there is no difference in complication rates between the two materials. However, there have never been any active studies to date. This study will serve as a randomized controlled trial comparing FlexHD and Alloderm. Several outcomes will be measured based off of inclusion and exclusion criteria to determine if either product is more suitable for use in breast reconstruction. This will be performed by randomly assigning patients to receive either FlexHD or Alloderm. Designated outcomes will be followed closely postoperatively. Outcomes will be statistically analyzed to determine complication rates between FlexHD and Alloderm and thus which product is better to use in breast reconstruction.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2016

Geographic Reach
1 country

1 active site

Status
withdrawn

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

February 20, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 26, 2015

Completed
1 year until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2017

Completed
Last Updated

July 18, 2018

Status Verified

July 1, 2018

Enrollment Period

1.8 years

First QC Date

February 20, 2015

Last Update Submit

July 16, 2018

Conditions

Breast Neoplasm

Outcome Measures

Primary Outcomes (1)

  • Wound Dehiscence

    time frame.

    One Year

Study Arms (2)

FlexHD

ACTIVE COMPARATOR

Patients randomly assigned to receive FlexHD for breast reconstruction.

Biological: FlexHD

Alloderm

ACTIVE COMPARATOR

Patients randomly assigned to receive Alloderm for breast reconstruction.

Biological: Alloderm

Interventions

FlexHDBIOLOGICAL

Patients will be randomized to receive FlexHD.

FlexHD
AllodermBIOLOGICAL

Patient will be randomized to receive Alloderm.

Alloderm

Eligibility Criteria

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

You may qualify if:

  • BMI\<30
  • No Prior Breast Radiation
  • No Prior Breast Reduction
  • No Diabetes Mellitus (IDDM and non-IDDM)
  • Non-smoker or quit \>6 weeks prior
  • No breast implants or prior breast implants
  • No inflammatory or autoimmune disorders
  • No current anticoagulation therapy
  • No current pregnant

You may not qualify if:

  • BMI \> 30
  • Prior Breast Radiation
  • Diabetes Mellitus - IDDM and non IDDM
  • Prior Breast Reduction
  • Active Smoker or Recently Quit \<6 weeks
  • Prior Breast Implants
  • Inflammatory/Autoimmune Condition (ex. Lupus)
  • Current Anticoagulation Therapy
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Related Publications (3)

  • Yuen JC, Yue CJ, Erickson SW, Cooper S, Boneti C, Henry-Tillman R, Klimberg S. Comparison between Freeze-dried and Ready-to-use AlloDerm in Alloplastic Breast Reconstruction. Plast Reconstr Surg Glob Open. 2014 Apr 7;2(3):e119. doi: 10.1097/GOX.0000000000000061. eCollection 2014 Mar.

    PMID: 25289313BACKGROUND

  • Liu DZ, Mathes DW, Neligan PC, Said HK, Louie O. Comparison of outcomes using AlloDerm versus FlexHD for implant-based breast reconstruction. Ann Plast Surg. 2014 May;72(5):503-7. doi: 10.1097/SAP.0b013e318268a87c.

    PMID: 23636114BACKGROUND

  • Brooke S, Mesa J, Uluer M, Michelotti B, Moyer K, Neves RI, Mackay D, Potochny J. Complications in tissue expander breast reconstruction: a comparison of AlloDerm, DermaMatrix, and FlexHD acellular inferior pole dermal slings. Ann Plast Surg. 2012 Oct;69(4):347-9. doi: 10.1097/SAP.0b013e31824b3d97.

    PMID: 22868313BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

FlexHDAlloderm

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Pallavi A Kumbla, MD

    UAMS

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2015

First Posted

February 26, 2015

Study Start

March 1, 2016

Primary Completion

December 21, 2017

Study Completion

December 21, 2017

Last Updated

July 18, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)