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Breast Implant Pocket Adjustment using ADM Layer Remodeling in Implant-based Breast Reconstruction

Breast Implant Pocket Adjustment using ADM Layer Remodeling in Implant-based Breast Reconstruction

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CRIS
Registry ID
KCT0007525
Enrollment
20
Registered
2022-07-21
Start date
2022-07-06
Completion date
Unknown
Last updated
2022-09-20

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

CHA Gangnam Medical Center CHA University
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: All subjects can participate in the clinical trial only when all of the following criteria are met. ? the patients who signed informed consent form ? 19 over year of age ? Must be one of the following items apply, i) in second stage, be expected wrinkling deformity due to mismatched between expanded implant pocket and implant contour or implant position seems asymmetry with contralateral breast after tissue expander removal, also lower pole skin flap could not be expanded enough because of skin flap necrosis or implant failure, among patients who got a breast reconstruction surgery using tissue expander. ii) Included one of the following symptoms, among patients who have already undergone ADM-assisted Implant-based breast reconstruction. (a) those patients with significant asymmetry in the breast reconstructed with breast implants compared to contralateral breast. (b) complain of breast hardness or pain due to capsular contracture

Exclusion criteria

Exclusion criteria: if any of the following items apply, the subject is excluded from the clinical trial. ? In case of radiation therapy in mastectomy site due to breast cancer ? Those with chemo therapy except breast cancer ? Those with whole body disease ? pregnant, lactating women ? Other clinical trial investigators judged to be inappropriate

Design outcomes

Secondary

MeasureTime frame
complication(acute and delayed complication);evaluation of satisfaction

Primary

MeasureTime frame
measurement of nipple position and inframammary fold position change

Countries

Korea, Republic of

Contacts

Public ContactEun-A hwang

CHA University

pshwang@chamc.co.kr+82-2-3468-3141

Outcome results

None listed

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