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Prospective study on quality assurance in reconstructive allogeneic breast surgery after prophylactic mastectomy

Prospective study on quality assurance in reconstructive allogeneic breast surgery after prophylactic mastectomy

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00035165
Enrollment
30
Registered
2024-10-16
Start date
2025-06-10
Completion date
Unknown
Last updated
2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Z40.0

Interventions

Group 1: A prospective cohort study is to be conducted at the Caritas Hospital St. Josef site. The study population consists of all patients for whom a prophylactic or therapeutic subcutaneous mastect

Sponsors

Hochschulzentrum für Plastische, Hand- und Wiederherstellungschirurgie Regensburg
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: -Patients with indication for subcutaneous mastectomy (preservation of the skin mantle) - Unilateral or bilateral removal of the mammary gland - With or without preservation of the nipple-areola complex (MAK) - Unilateral or bilateral breast cancer - Purely prophylactic removal of the mammary gland - Direct allogeneic breast reconstruction - Evidence of a genetic predisposition - Without evidence of a genetic mutation for tumor anxiety

Exclusion criteria

Exclusion criteria: - Two-stage procedure, e.g. with temporary insertion of an expander - Reconstruction with autologous tissue - Patients <18 years of age - Patients in need of care / particularly vulnerable patients

Design outcomes

Primary

MeasureTime frame
Layer thickness of the skin/soft tissue mantle determined intraoperatively using marking wires

Secondary

MeasureTime frame
Histopathologically determined layer thickness in the wound edge area

Countries

Germany

Contacts

Public ContactAnna Wiesmeier

Hochschulzentrum für Plastische, Hand- und Wiederherstellungschirurgie Regensburg

anna.wiesmeier@ukr.de*499417823110

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026