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

JRCT ID: jRCTs032220240

Registered date:03/08/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Benign or malignant breast tumor or hereditary breast and ovarian cancer
• Date of first enrollment: 26/08/2022
• Target sample size: 12
• Study type: Interventional
• Intervention(s): 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 could not be covered by the pectoralis major muscle, which was conventionally covered by the serratus anterior muscle.

Outcome(s)

• Primary Outcome: Silicon breast implant removal rate within 3 months after surgery.

Secondary Outcome

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.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Female

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Aihara Yukiko
• Source(s) of Monetary Support: University of Tsukuba Hospital