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Safety and effectiveness study of reinforcing mastectmy flap using NEOVEIL sheet in implant breast reconstruction

Safety and effectiveness study of reinforcing mastectmy flap using NEOVEIL sheet in immediate breast reconstruction with silicon breast implant

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs032220240
Enrollment
12
Registered
2022-08-03
Start date
2022-08-26
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Benign or malignant breast tumor or hereditary breast and ovarian cancer

Interventions

In the immediate breast reconstruction with silicon breast implant after nipple sparing mastectomy, we use NEOVEIL sheet to cover the range from the caudal side of the chest to the outside, which coul

Sponsors

Aihara Yukiko
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1) Patients with benign or malignant breast tumor or hereditary breast and ovarian cancer syndrome who were planning to undergo immediate breast reconstruction with silicon breast impalnt after unilateral or bilateral nipple-sparing mastectomy. 2) Patients with benign or malignant breast tumor or hereditary breast and ovarian cancer syndrome who were indicaded for immediate breast reconstruction with tissue expander-silicon breast impalnt using conventional method( muscular poket method) after unilateral or bilateral nipple-sparing mastectomy. 3) In the case of breast cancer which is stage II or lower on preoperative diagnosis, patients with no skin infiltration, pectoralis major muscle infiltration, severe lymph node metastasis (N2a or higher). 4) Patients aged 18 years or older at the time of obtaining the consent form. 5) Silicon breast implant size is 110ml or more, 600ml or less.

Exclusion criteria

Exclusion criteria: 1) Patients with allergies to polyglucholic acid. 2) Patients with active infection. 3) Patients who received prior radiation therapy on the side of their breast who were planning to undergo breast reconstruction. 4) Pregnant or lactating patients. 5) Patients who smoke within 4 weeks before obtaining the consent form. 6) Patients with uncontrolled diabetes at the time of consent. 7) Patients who need radiation therapy to the reconstructed breast within 1 month after surgery. 8) Patients with impaired wound healing such as local blood flow insufficiency or the effects of drugs. 9) In addition, patients who are judged by the research-responsible doctor to be inappropriate as subjects.

Design outcomes

Primary

MeasureTime frame
Silicon breast implant removal rate within 3 months after surgery.

Secondary

MeasureTime frame
Infection rate within 3 months after surgery. Skin infection rate. Type of silicon breast implant. Reconstruction time. Drain detention period. Hospitalization period. Rate of immediate silicon breast reconstructions after patient registration.

Contacts

Public ContactMasahiro Sasaki

University of Tsukuba Hospital

sasaki.masahiro.dw@ms.hosp.tsukuba.ac.jp+81-29-853-3525

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026