Single center, randomized, prospective, comparative study to evaluate the effect of ADM coverage method in prepectoral implant breast reconstruction

Single center, randomized, prospective, comparative study to evaluate the effect of ADM wrapping and tenting method in prepectoral implant breast reconstruction

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0007046

Enrollment

Registered

2022-03-04

Start date

2022-03-30

Completion date

Unknown

Last updated

2022-03-08

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

Conditions

None listed

Interventions

Medical Device : To evaluate the effect of ADM wrapping and tenting method in breast reconstruction

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients over the age of 19 2) Patients who need mastectomy for breast cancer 3) Patients who are planning to undergo one stage immediate breast reconstruction (prepectoral) using an implant after mastectomy (skin preservation/nipple preservation) 4) Patients who will use acellular allogeneic dermis for breast reconstruction 5) Patients who consent to the clinical study and can follow-up during the study period

Exclusion criteria

Exclusion criteria: 1) Patients undergoing chemotherapy for cancer other than breast cancer 2) Patients with confirmed local recurrence or systemic metastasis of breast cancer 3) Patients who are scheduled to undergo delayed breast reconstruction (two stage) during breast reconstruction 4) Patients with underlying diseases such as infectious diseases, autoimmune diseases (especially rheumatic diseases, etc.), and blood clotting disorders 5) Patients with systemic diseases other than breast cancer (especially uncontrolled diabetes, etc.) 6) Pregnant or lactating women 7) Patients who are judged by the principle investigator to be difficult to participate in the study (Current smokers, moderate obesity, etc.)

Design outcomes

Primary

Measure	Time frame
Comparison of Capsular Contracture after Reconstructive Surgery	—

Secondary

Measure	Time frame
Patient Satisfaction Assessment After Reconstructive Surgery;Comparison of Capsular Contracture after Reconstructive Surgery	—

Countries

Korea, Republic of

Contacts

Public ContactHyeongcheol lee

Korea University Anam Hospital

jobdragon@hanmail.net+82-2-920-5440

Outcome results