Evaluating skin flap thickness and glandular tissue in prophylactic mastectomy
Prophylactic Mastectomy: Prospective Evaluation of the Correlation Between Skin Flap Thickness, Residual Glandular Tissue and Skin Necrosis by Imaging and Clinical Examination
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 type | Observational |
|---|---|
| Enrollment | 45 (estimated) |
| Ages | 18 Years to 74 Years |
| Sex | Female |
| Sponsor | Umeå University Academic / other |
| Locations | 1 site (Umeå) |
| Trial ID | NCT05162677 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are women aged 18-74 who are recommended for prophylactic mastectomy due to hereditary factors.
Not a fit: Patients undergoing mastectomy due to existing breast cancer will not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Umeå
- Plastic Surgery Unit, Umeå University hospital — Umeå, Sweden (Recruiting)
Study contacts
- Study coordinator: Rebecca Wiberg, MD PhD
- Email: rebecka.wiberg@umu.se
- Phone: +4690-785 0000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.