臨床研究等提出・公開システム

A single-arm clinical study on the efficacy and safety of polyglycolic acid sheet (Neovert<R>) as a substitute for fascia in primary breast reconstruction

Efficacy and safety of polyglycolic acid sheet in primary breast reconstruction

Mori Hiroki

Institute of Science Tokyo Hospital

1-5-45 Yushima Bunkyo-ku Tokyo

moriplas@tmd.ac.jp

Yasunaga Mami

Institute of Science Tokyo Hospital

1-5-45 Yushima Bunkyo-ku Tokyo

+81-3-5803-5923

hisho.plas@tmd.ac.jp

Recruiting

July. 18, 2025

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

1) Patients undergoing unilateral or bilateral mastectomy for benign or malignant breast tumors and hereditary breast and ovarian cancer syndrome who meet either of the following conditions
<1>Patients who are scheduled to undergo primary one-stage breast reconstruction using breast implants (BI) after resection.
<2> Patients scheduled for primary two-stage breast reconstruction using a tissue expander (TE) after res
ection
3) Patients whose BI to be used is less than 650 ml
4) Patients with breast cancer, Stage IIIA or less in the preoperative diagnosis, without skin invasion, pectoralis major muscle invasion, or advanced lymph node metastasis (N2a or higher)
5) Patients who are at least 18 years of age at the time of obtaining consent
6) Patients who have given written consent to participate in this clinical study

1) Patients allergic to PGA
2) Patients with active infection
3) Patients with a history of radiation to the chest area to be reconstructed (e.g., ipsilateral mammary gland or axilla, ipsilateral lung)
4) Patients who have smoked within 4 weeks prior to obtaining consent
5) Patients with poorly controlled diabetes mellitus
6) Patients who need to receive radiation to the reconstructed breast in the early postoperative period (within 1 month)
7) Patients with conditions that impair wound healing, such as inadequate local blood flow or the effects of medications
8) Pregnant or lactating patients
9)Other patients who are judged by the principal investigator (subinvestigator) to be inappropriate as subjects.

Female

Patients undergoing primary breast reconstruction with artificial prostheses

In cases where a tissue expander (TE) or breast implant (BI) is inserted under the pectoralis major muscle and the defect of the serratus anterior or external oblique fascia is too large to cover the TE or BI, PGA sheet (Neovert<R>) is used as a substitute fascia material.
For submastoid implantation:
When the fascia of the serratus anterior and external oblique abdominis muscles are removed together with the tumor after mastectomy, the outer tail of the TE or BI is covered with a PGA sheet and sutured to the pectoralis major muscle and the serratus anterior and external oblique muscles.
For subcutaneous implantation:
After mastectomy, a PGA sheet is applied to the caudal and lateral sides of the TE or BI for support and suture fixation to the chest wall.

Breast implants, breast tumor

PGA sheet (Neovert<R>)

Extraction rate of TE or BI within 3 months after surgery

1)Infection rate within 3 months after surgery
2)Skin necrosis rate within 3 months after surgery
3)Extraction rate of TE or BI during all periods
4)Operating time
5)Duration of drain placement
6)Period of hospitalization
7)Percentage of successful primary reconstruction

Safety endpoints
Percentage of adverse events and failures

+81-3-5803-4574

May. 23, 2025

No

none