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Prospective study to evaluate the protective effect of BellaCell acellular dermal matrix from radiation therapy in prosthetic breast reconstruction

Prospective study to evaluate the protective effect of BellaCell acellular dermal matrix from radiation therapy in prosthetic breast reconstruction

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CRIS
Registry ID
KCT0005935
Enrollment
80
Registered
2021-02-23
Start date
2021-10-18
Completion date
Unknown
Last updated
2023-08-01

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

Conditions

None listed

Interventions

Sponsors

Asan Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Breast cancer patients aged 20 years or older and under 80 years of age who undergo breast reconstruction immediately after total mastectomy

Exclusion criteria

Exclusion criteria: 1) Those who have previously had mastectomy, breast augmentation, or breast reconstruction 2) When both breasts are performed at the same time or when the opposite side is performed 3) When inserting an expander 4) Patients who have undergone organ transplant and are taking immunosuppressants 5) Those whose mental state may affect the progress of clinical trials due to alcohol and drug abuse 6) Those who are unable to conduct the survey conducted in this clinical trial 7) Those who participated in other clinical trials within 120 days before screening 8) When other investigators determine that it is inappropriate for this clinical trial

Design outcomes

Primary

MeasureTime frame
Postoperative chemotherapy and radiation therapy

Secondary

MeasureTime frame
Vital sign (Blood pressure, pulse, body temperature);Adverse effect(Previous abdominal resection, augmentation, reconstruction, dilator insertion, organ transplantation, taking immunosuppressants, alcohol and drug abuse, etc.);Breast reconstruction surgery;Evaluate the progress of surgery and the presence of complications

Countries

Korea, Republic of

Contacts

Public ContactHyun Ho

Asan Medical Center

tripleh1952@gmail.com+82-2-3010-5914

Outcome results

None listed

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