Evaluating AlloMax in Immediate Expander-Based Breast Rec... | NCT01372917

Studies
Evaluating AlloMax in Immediate Expander-Based Breast Reconstruction Study

NCT01372917

Sponsor

National Center for Plastic Surgery, Virginia

Status

Completed

Last Update Posted

Jun 13, 2012Estimated

Enrollment

39Actual

Phase

Not provided

Conditions

Malignant Neoplasm of the Breast
Acquired Absence of the Breast

Interventions

Not provided

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

Jun 2012

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

Jan 2010

Primary Completion Date

Feb 2011Actual

Completion Date

Aug 2011Actual

First Submitted Date

Jun 13, 2011

First Submission Date that Met QC Criteria

Jun 13, 2011

First Posted Date

Jun 14, 2011Estimated

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

Jun 11, 2012

Last Update Posted Date

Jun 13, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mark L. Venturi, MD FACS, Physician, National Center for Plastic Surgery, VirginiaPrincipal Investigator

Lead Sponsor

National Center for Plastic Surgery, VirginiaOTHER

Collaborators

Name	Class
Inova Health Care Services	OTHER
Ohio State University Comprehensive Cancer Center	OTHER
Walter Reed Army Medical Center	FED
C. R. Bard

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

The study is a prospective multi-centered cohort study designed to determine the safety and efficacy of AlloMax in immediate expander-based breast reconstruction. Specifically, the study is designed to determine if sterility of human acellular dermal matrix results in a lower incidence of infection and seroma. The study will determine if gamma radiation, as a method of terminally sterilizing human acellular dermal matrix, has a negative impact on graft incorporation into the host tissue.

Detailed Description

Not provided

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

39Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Allomax		The cohort consists of immediate breast reconstruction patients who have AlloMax placed at the time of their tissue expander based immediate breast reconstruction.

Interventions

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients having immediate breast reconstruction with tissue expanders
Unilateral or bilateral reconstructions
Ages 25 - 65
All breast cancer stages and types

Exclusion Criteria:

BMI > 35
Active smokers
Diabetics
History of radiation or planned radiation
Immunocompromised patients

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Breast cancer patients who opt for immediate breast reconstruction with tissue expanders from clinic.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Center for Plastic Surgery		McLean	Virginia	22102	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22990174	Derived	Venturi ML, Mesbahi AN, Boehmler JH 4th, Marrogi AJ. Evaluating sterile human acellular dermal matrix in immediate expander-based breast reconstruction: a multicenter, prospective, cohort study. Plast Reconstr Surg. 2013 Jan;131(1):9e-18e. doi: 10.1097/PRS.0b013e3182729d4f.

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