Prospective Trial of Subcutaneous Versus Subpectoral 2-St... | NCT02775409

Studies
Prospective Trial of Subcutaneous Versus Subpectoral 2-Staged Implant-Based Breast Reconstruction

NCT02775409

Sponsor

Mayo Clinic

Status

Completed

Last Update Posted

Dec 30, 2021Actual

Enrollment

200Actual

Phase

Not Applicable

Conditions

Breast Reconstruction Following Mastectomy

Interventions

Subcutaneous placement
Submuscular placement

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

Dec 2021

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

May 1, 2016Actual

Primary Completion Date

Feb 6, 2020Actual

Completion Date

Feb 6, 2020Actual

First Submitted Date

May 13, 2016

First Submission Date that Met QC Criteria

May 13, 2016

First Posted Date

May 17, 2016Estimated

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

Dec 29, 2021

Last Update Posted Date

Dec 30, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

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

This study is for women scheduled to have immediate breast reconstruction following mastectomy using a tissue expander. The primary purpose of this study is to learn whether there are differences in the outcome between placing the tissue expander above the muscle or below the muscle. The study will evaluate pain, wellbeing, and overall satisfaction with reconstruction. A secondary purpose is to learn whether there are differences in complications and costs between the two locations.

Detailed Description

Not provided

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

200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Subcutaneous	Active Comparator	Subcutaneous placement of tissue expander	Procedure: Subcutaneous placement
Submuscular	Active Comparator	Submuscular placement of tissue expander	Procedure: Submuscular placement

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Subcutaneous placement	Procedure	The tissue expander will be placed above the muscle.	Subcutaneous

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in patient satisfaction	Difference in patient satisfaction between the two groups using the physical well being scale.	Baseline, Year 3

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Women at least 18 years of age, who will undergo immediate unilateral or bilateral implant-based breast reconstruction following therapeutic skin-sparing or nipple-sparing mastectomy.
Women at least 18 years of age, who will undergo immediate bilateral implant-based breast reconstruction following risk-reduction (prophylactic) skin-sparing or nipple-sparing mastectomy.

Exclusion Criteria:

Subjects who are unable to read or speak English.
Patients desiring autologous reconstruction.
BMI >40.
History of radiation therapy to the breast(s), e.g. history of breast conservation therapy.
Current nicotine and/or tobacco use.
Documented diagnosis of chronic pain.
Women who are pregnant or breast-feeding *
Women who decline the use of acellular dermal matrix (ADM).
Surgeon decision not to proceed with tissue expander reconstruction.
Women undergoing single stage (straight to implant) reconstruction.

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

Name	Affiliation	Role
Minh-Doan Nguyen, MD	Mayo Clinic	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic		Rochester	Minnesota	55905	United States

Label	URL
Mayo Clinic Clinical Trials	View source

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Present/publish results at professional meetings/journals

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided