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

December 29, 2021 updated by: Minh-Doan Nguyen, Mayo Clinic
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. 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.
  2. 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:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Subcutaneous
Subcutaneous placement of tissue expander
Procedure: Subcutaneous placement
The tissue expander will be placed above the muscle.
Active Comparator: Submuscular
Submuscular placement of tissue expander
Procedure: Submuscular placement
The tissue expander will be placed below the muscle

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Minh-Doan Nguyen, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2016

Primary Completion (Actual)

February 6, 2020

Study Completion (Actual)

February 6, 2020

Study Registration Dates

First Submitted

May 13, 2016

First Submitted That Met QC Criteria

May 13, 2016

First Posted (Estimate)

May 17, 2016

Study Record Updates

Last Update Posted (Actual)

December 30, 2021

Last Update Submitted That Met QC Criteria

December 29, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 16-000539

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Present/publish results at professional meetings/journals

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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