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NCT Number: NCT05162677

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

Breast cancer is the most common form of cancer among women. Five to ten percent of all breast cancers are due to hereditary factors, with pathogenic variants in the breast cancer genes BRCA1/2 accounting for 2-5% of all breast cancer. Women with pathogenic variants in BRAC1/2 and other pathogenic gene mutations leading to an increased risk of breast cancer can undergo prophylactic mastectomy, reducing the risk of breast cancer up to 90%. Among women who have undergone prophylactic mastectomy, 1-1,9% are diagnosed with breast cancer, but little is known about the correlation between residual glandular tissue and skin flap thickness, as well as the oncological risk of residual glandular tissue. Furthermore, there is a balance between how much subcutaneous tissue should be resected to achieve maximal reduction of glandular tissue, while leaving viable skin flaps. In addition, there are established surveillance guidelines for women with pathogenic variants in BRCA1/2 who do not undergo risk-reducing surgery, but no published consensus or guidelines regarding appropriate medical follow-up for those who opt for prophylactic mastectomy. The aim of this study is to investigate the correlation between skin flap thickness, residual glandular tissue and skin flap necrosis following prophylactic mastectomy in women with results from postoperative magnetic resonance tomography, ultrasound and physical examination, as well as evaluate patient satisfaction and quality of life pre- and postoperatively with different questionnaires.

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Key information

Conditions

Prophylactic Mastectomy

Age range

18 year–74 year

Sex eligibility

Female

Study type

Observational

Primary location

Plastic Surgery Unit, Umeå University hospital

Umeå, Sweden

Location status: Recruiting

Location contact

Rebecca Wiberg, MD, PhD

CONTACT

[email protected]

+4670-3884369

Who can participate

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

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.

Treatment and study plan

Primary outcomes

  1. Presence of residual glandular tissue

    Time frame: Residual glandular tissue will be evaluated 1 year postoperatively

    Residual glandular tissue will be reported as being present or not present through postoperative evaluation with magnetic resonance tomography, ultrasound and mammography. The quadrants of the left and right breast will be examined after which the findings will be documented in pre-printed templates.

  2. Presence of residual glandular tissue

    Time frame: Residual glandular tissue will be evaluated 3 years postoperatively

    Residual glandular tissue will be reported as being present or not present through postoperative evaluation with magnetic resonance tomography, ultrasound and mammography. The quadrants of the left and right breast will be examined after which the findings will be documented in pre-printed templates.

  3. Measurement of skin flap thickness

    Time frame: Skin flap thickness will be evaluated 1 year postoperatively

    The skin flap thickness will be evaluated postoperatively with magnetic resonance tomography, ultrasound and mammography. The quadrants of the left and right breast will be examined after which the findings will be documented in pre-printed templates. The skin flap thickness will be defined as the thickness of the skin (epidermis, dermis, subcutaneous tissue) measured at the examinations rather than the thickness of the skin flaps perioperatively. All measurements will be made in mm.

  4. Measurement of skin flap thickness

    Time frame: Skin flap thickness will be evaluated 3 years postoperatively

    The skin flap thickness will be evaluated postoperatively with magnetic resonance tomography, ultrasound and mammography. The quadrants of the left and right breast will be examined after which the findings will be documented in pre-printed templates. The skin flap thickness will be defined as the thickness of the skin (epidermis, dermis, subcutaneous tissue) measured at the examinations rather than the thickness of the skin flaps perioperatively. All measurements will be made in mm.

Secondary outcomes

  1. Change in evaluation of patient satisfaction

    Time frame: Change in patient satisfaction will be evaluated pre- and postoperatively. The women will receive the questionnaires 1 month preoperatively, 1 year postoperatively and 3 years postoperatively.

    Patient satisfaction will be evaluated pre- and postoperatively with four different validated questionnaires; BREAST-Q, BRECON23, QLQ-C30 and Cancer-worry scale.

  2. Change in evaluation of patient quality of life

    Time frame: Change in patient quality of life will be evaluated pre- and postoperatively. The women will receive the questionnaires 1 month preoperatively, 1 year postoperatively and 3 years postoperatively.

    Patient quality of life will be evaluated pre- and postoperatively with four different validated questionnaires; BREAST-Q, BRECON23, QLQ-C30 and Cancer-worry scale.

  3. Number of participants with acute postoperative complications

    Time frame: Clinical examination will be performed 2-4 weeks postoperatively.

    Postoperative complications will be evaluated postoperatively by clinical examination and documented in pre-printed templates, and pictures will be taken. The complications will include breast related complications (skin flap necrosis, infection, hematoma, seroma and implant loss) and non-breast related complications (deep vein thrombosis, pulmonary embolism).

  4. Number of participants with long term postoperative complications

    Time frame: Clinical examination will be performed 1 year postoperatively.

    Postoperative complications will be evaluated postoperatively by clinical examination and documented in pre-printed templates, and pictures will be taken. The complications will include breast related complications (skin flap necrosis, infection, hematoma, seroma and implant loss) and non-breast related complications (deep vein thrombosis, pulmonary embolism).

  5. Number of participants with long term postoperative complications

    Time frame: Clinical examination will be performed 3 years postoperatively.

    Postoperative complications will be evaluated postoperatively by clinical examination and documented in pre-printed templates, and pictures will be taken. The complications will include breast related complications (skin flap necrosis, infection, hematoma, seroma and implant loss) and non-breast related complications (deep vein thrombosis, pulmonary embolism).

Study contacts

Contact information is provided by the study sponsor or research team.

Rebecca Wiberg, MD PhD

CONTACT

[email protected]

+4690-785 0000

Sponsors and collaborators

Lead sponsor

Umeå University

Other

Registry information

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Dec 17, 2021
Registry last updated
May 8, 2024

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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