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Completed

NCT Number: NCT01002014

Nipple Sparing Mastectomy - Cosmetic Outcomes

The purpose of this study is to observe the cosmetic outcomes, patient satisfaction, and complications after skin sparing mastectomy with preservation of the nipple areolar complex.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Breast Reconstruction Cosmesis Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Levine Cancer Institute

Charlotte, North Carolina, 28204, United States

About this study

The outcomes will be observed in patients with both known cancer diagnosis and in those with indications for prophylactic mastectomy. The cosmetic appearance and complications will be followed through several post operative visits throughout the duration of the study. This study is conducted in conjunction with the plastic and reconstructive surgeons who will be performing the breast reconstruction procedures. Patient satisfaction will be measured via survey format. In addition, local recurrence rates will be compared to patients undergoing traditional mastectomy.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients requiring mastectomy for cancer and/or prophylaxis
  • Age greater than or equal to 18 at time of surgery
  • BMI less than or equal to 35
  • If mastectomy is indicated for removal of breast cancer, tumor is clinically T1 or T2

Exclusion criteria

  • Currently smoking
  • Prior radiation to the affected breast
  • Systemic lupus erythematosus
  • Central tumor location and/or tumor within 2 cm of NAC
  • Paget's disease of the nipple
  • Clinical evidence of tumor involvement in the nipple
  • Clinical evidence of axillary nodal tumor involvement
  • Lymphovascular invasion of the tumor on core biopsy

Treatment and study plan

Nipple sparing mastectomy

Procedure

Skin sparing mastectomy with preservation of the nipple areolar complex

Primary outcomes

  1. Cosmetic Appearance

    Time frame: First Post Operative year

  2. Patient Satisfaction

    Time frame: First Post Operative Year

  3. Presence of tumor in nipple areolar complex frozen section

    Time frame: Duration of Study

  4. Presence of tumor in nipple areolar complex permanent histology

    Time frame: Duration of study

Secondary outcomes

  1. Complications

    Time frame: First Post Operative year

  2. Local Recurrence

    Time frame: One year

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

Preservation of the Nipple Areolar Complex With Skin Sparing Mastectomy

Important dates

Study start
2009
Primary completion
2016
Study completion
2018
First posted
Oct 27, 2009
Registry last updated
Apr 21, 2022

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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