Comparison of FlexHD and Alloderm Outcomes in Breast Reco... | NCT02372305

Studies
Comparison of FlexHD and Alloderm Outcomes in Breast Reconstructive Surgery

NCT02372305

Sponsor

University of Arkansas

Status

Withdrawn

Last Update Posted

Jul 18, 2018Actual

Enrollment

0Actual

Phase

Phase 4

Conditions

Breast Neoplasm

Interventions

FlexHD
Alloderm

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

Jul 2018

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

PI is no longer at institution. IRB closed study due to lack of response from PI

Expanded Access Info

Start Date

Mar 2016

Primary Completion Date

Dec 21, 2017Actual

Completion Date

Dec 21, 2017Actual

First Submitted Date

Feb 20, 2015

First Submission Date that Met QC Criteria

Feb 25, 2015

First Posted Date

Feb 26, 2015Estimated

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

Jul 16, 2018

Last Update Posted Date

Jul 18, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

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.

Detailed Description

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
FlexHD	Biological	Patients will be randomized to receive FlexHD.	FlexHD

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Wound Dehiscence	time frame.	One Year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

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

Name	Affiliation	Role
Pallavi A Kumbla, MD	UAMS	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Arkansas for Medical Sciences		Little Rock	Arkansas	72205	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25289313	Background	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.
23636114	Background

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases