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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02775409

Enrollment

200

Registered

2016-05-17

Start date

2016-05-01

Completion date

2020-02-06

Last updated

2021-12-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Reconstruction Following Mastectomy

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.

Interventions

PROCEDURESubcutaneous placement

The tissue expander will be placed above the muscle.

PROCEDURESubmuscular placement

The tissue expander will be placed below the muscle

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026