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Completed

NCT Number: NCT02775409

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

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.

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Key information

Conditions

Breast Reconstruction Following Mastectomy

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Subcutaneous placement

Procedure

The tissue expander will be placed above the muscle.

Submuscular placement

Procedure

The tissue expander will be placed below the muscle

Primary outcomes

  1. Change in patient satisfaction

    Time frame: Baseline, Year 3

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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
May 17, 2016
Registry last updated
Dec 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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