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

• Sponsor: Mayo Clinic (Other)
• Overall Status: Completed
• CT.gov ID: NCT02775409
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Arms: 2
• Actual Duration (Months): 45.2
• Patients Per Site Per Month: 4.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Reconstruction Following Mastectomy	Procedure: Subcutaneous placement; Procedure: Submuscular placement	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Prospective Trial of Subcutaneous Versus Subpectoral 2-Staged Implant-Based Breast Reconstruction
• Actual Study Start Date: May 1, 2016
• Actual Primary Completion Date: Feb 6, 2020
• Actual Study Completion Date: Feb 6, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change in patient satisfaction [Baseline, Year 3]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

• Mayo Clinic

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Mayo Clinic Clinical Trials

Publications

None provided.

• Responsible Party: Minh-Doan Nguyen, Assistant Professor of Plastic Surgery, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT02775409
• Other Study ID Numbers: 16-000539
• First Posted: May 17, 2016
• Last Update Posted: Dec 30, 2021
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Dec 30, 2021