Clinical trial Recruiting at 1 site Observational Ages 18 to 74 Women only

Evaluating skin flap thickness and glandular tissue in prophylactic mastectomy

Official title: Prophylactic Mastectomy: Prospective Evaluation of the Correlation Between Skin Flap Thickness, Residual Glandular Tissue and Skin Necrosis by Imaging and Clinical Examination

Run by Umeå University · NCT05162677 · Data updated 2026-11-12

This study looks at how the thickness of skin and leftover breast tissue affects healing in women with a high risk of breast cancer who are having preventive mastectomies.

Quick facts

Study typeObservational
Ages18 Years to 74 Years
SexWomen only
Enrollment45 (estimated)
SponsorUmeå University
Academic / other
Locations1 site (Umeå)
StatusRecruiting
StartedAugust 25, 2022
Main results expectedDecember 31, 2027
Study endsDecember 31, 2027
Registry record updatedMay 8, 2024
Trial IDNCT05162677 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are women aged 18-74 who are recommended for prophylactic mastectomy due to hereditary factors.

Probably not a fit

Patients undergoing mastectomy due to existing breast cancer will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to assess the relationship between skin flap thickness, residual glandular tissue, and the occurrence of skin necrosis in women undergoing prophylactic mastectomy due to hereditary breast cancer risk. It focuses on patients with pathogenic variants in BRCA1/2 and other genes, aiming to optimize surgical techniques to minimize residual tissue while preserving viable skin. The study will involve clinical examinations and imaging to gather data on these factors and their implications for breast cancer risk.

Why it matters

Potential benefit: If successful, this study could enhance surgical outcomes and reduce the risk of breast cancer in women at high genetic risk.

How similar studies have gone: While there is limited data on this specific correlation, similar studies have explored the implications of surgical techniques in breast cancer prevention, indicating potential for meaningful insights.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Women that are recommended prophylactic mastectomy at the Department of Plastic Surgery at Umeå University hospital due to hereditary factors that have been investigated by clinical geneticists.
* Age between 18-74 years

Exclusion Criteria:

* Women undergoing mastectomy due to cancer.
* Age \< 18 years or \> 74 years.

Where it's running

  • Plastic Surgery Unit, Umeå University hospital
    Umeå, Sweden
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.