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

NCT02775409 | Completed DMC

• 1 other identifier: 16-000539
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Reconstruction Following Mastectomy

Outcome Measures

Primary Outcomes (1)

• Change in patient satisfaction

  Difference in patient satisfaction between the two groups using the physical well being scale.

  Baseline, Year 3

Study Arms (2)

Subcutaneous

ACTIVE COMPARATOR

Subcutaneous placement of tissue expander

Procedure: Subcutaneous placement

Submuscular

ACTIVE COMPARATOR

Submuscular placement of tissue expander

Procedure: Submuscular placement

Interventions

Subcutaneous placement PROCEDURE

The tissue expander will be placed above the muscle.

Subcutaneous

Submuscular placement PROCEDURE

The tissue expander will be placed below the muscle

Submuscular

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

Study Officials

• Minh-Doan Nguyen, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Plastic Surgery

Study Record Dates

• First Submitted: May 13, 2016
• First Posted: May 17, 2016
• Study Start: May 1, 2016
• Primary Completion: February 6, 2020
• Study Completion: February 6, 2020
• Last Updated: December 30, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will share

Locations

US (1)