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

Breast Reconstruction Following Mastectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02775409
• Other study ID #: 16-000539
• Status: Completed
• Phase: N/A
• Start date: May 1, 2016
• Est. completion date: February 6, 2020

Study information

• Verified date: December 2021
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: February 6, 2020
• Est. primary completion date: February 6, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Reconstruction Following Mastectomy

Intervention

Procedure:
• Subcutaneous placement
The tissue expander will be placed above the muscle.
• Submuscular placement
The tissue expander will be placed below the muscle

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in patient satisfaction	Difference in patient satisfaction between the two groups using the physical well being scale.	Baseline, Year 3

External Links

•   Mayo Clinic Clinical Trials