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Changes in breast morphology and the correlative factors after direct-to-implant prepectoral breast reconstruction following nipple-sparing mastectomy : prospective observational study

Changes in breast morphology and the correlative factors after direct-to-implant prepectoral breast reconstruction following nipple-sparing mastectomy : prospective observational study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CRIS
Registry ID
KCT0007105
Enrollment
100
Registered
2022-03-21
Start date
2022-03-09
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

Pusan National University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: All patients can participate in this study only if they meet all of the following criteria. (1) Patients over 19 years of age (2) Among patients who need total mastectomy for breast cancer, patients who undergo surgery through nipple-sparing mastectomy. (3) Patients who undergo direct-to-implant prepectoral technique with breast implants after total mastectomy (4) Patients who use Acelluar Dermal Matrix for breast reconstruction (5) Patients who agree to participate in the study and can be followed up within the study period

Exclusion criteria

Exclusion criteria: Patients with any of the following criteria were excluded from this study. (1) A patient undergoing chemotherapy for cancer other than breast cancer (2) Patients with confirmed local recurrence or systemic metastasis of breast cancer

Design outcomes

Primary

MeasureTime frame
3D breast scanning (Linear Distance, Breast projection, Breast volume/volumetric distribution, Breast surface/area distribution, Nipple position, Areola diameter, N-IMF distance)

Secondary

MeasureTime frame
Manual measurement (Areola diameter, N-IMF distance)

Countries

Korea, Republic of

Contacts

Public Contactyejin son

Pusan National University Hospital

syj4134@naver.com+82-51-240-7553

Outcome results

None listed

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