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Comparative evaluation of capsule formation and contracture severity with various ADMs in expander-implant breast reconstruction after postmastectomy radiotherapy : prospective observational study

Comparative evaluation of capsule formation and contracture severity with various ADMs in expander-implant breast reconstruction after postmastectomy radiotherapy : prospective observational study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CRIS
Registry ID
KCT0007065
Enrollment
66
Registered
2022-03-10
Start date
2020-05-26
Completion date
Unknown
Last updated
2022-04-04

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

Conditions

None listed

Interventions

None listed

Sponsors

Seoul National University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Patients over 19 years of age (2) Patients who need total mastectomy for breast cancer (3) Patients undergoing immediate two-stage implant breast reconstruction after total mastectomy (skin preservation) is performed. (4) Patients who use Acelluar Dermal Matrix for breast reconstruction (5) Patients who need radiotherapy after breast reconstruction (6) Patients who agree to participate in the study and can be followed up within the study period

Exclusion criteria

Exclusion criteria: (1) A patient undergoing chemotherapy for cancer other than breast cancer (2) Patients with confirmed local recurrence or systemic metastasis of breast cancer (3) Patients with underlying conditions such as infectious diseases, systemic autoimmune diseases (especially rheumatoid diseases, etc.), and blood coagulation disorders (4) Patients with systemic diseases other than breast cancer (5) Pregnant women or lactating women (6) Other patients who were judged to be difficult to participate in this study by the investigator

Design outcomes

Primary

MeasureTime frame
tissue engraft evaluation;Evaluation of the effectiveness of capsule formation

Secondary

MeasureTime frame
Patient satisfaction evaluation;Complications evaluation

Countries

Korea, Republic of

Contacts

Public ContactUng Sik Jin

Seoul National University Hospital

usj1011@snu.ac.kr+82-2-2072-3642

Outcome results

None listed

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