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

Not Applicable

Completed

• Conditions: Breast Reconstruction Following Mastectomy

• Registration Number: NCT02775409
• Lead Sponsor: Mayo Clinic

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 available

Study Timeline

• Study Start: 2016-05-01
• Study First Submitted: 2016-05-13
• Study First Submitted QC: 2016-05-13
• Study First Posted: 2016-05-17
• Primary Completion: 2020-02-06
• Study Completion: 2020-02-06
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-29
• Last Update Posted: 2021-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States