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Comparison of the degree of capsular formation and contracture according to the radiation therapy when reconstructing immediate-2-stage using Acellular dermal matrix in breast cancer patients: a single center, prospective observational study

Comparison of the degree of capsular formation and contracture according to the radiation therapy when reconstructing immediate-2-stage using Acellular dermal matrix in breast cancer patients: a single center, prospective observational study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CRIS
Registry ID
KCT0011384
Enrollment
100
Registered
2025-12-29
Start date
2025-12-29
Completion date
Unknown
Last updated
2026-01-05

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

Samsung Medical Center
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: ?Patients aged 19 years or older ?Patients who underwent immediate two-stage implant-based breast reconstruction following mastectomy ?Patients in whom acellular dermal matrix (ADM) was used during breast reconstruction ?Patients who provided written informed consent and were able to be followed up throughout the study period

Exclusion criteria

Exclusion criteria: ?Patients receiving chemotherapy for malignancies other than breast cancer ?Patients with confirmed local recurrence or distant metastasis of breast cancer ?Patients with underlying conditions such as infectious diseases, systemic autoimmune diseases (including rheumatoid diseases), or coagulation disorders ?Patients with systemic diseases other than breast cancer ?Pregnant or breastfeeding women ?Patients deemed by the principal investigator to be unsuitable for participation in this study

Design outcomes

Primary

MeasureTime frame
Assessment of capsular contracture

Secondary

MeasureTime frame
Assessment of patient satisfaction;Assessment of complication rates

Countries

Korea, Republic of

Contacts

Public ContactJeon Byung-Joon

Samsung Medical Center

saintmed@naver.com+82-2-3410-2235

Outcome results

None listed

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