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A clinical study on subcutaneous breast insertion of tissue expanders using Neoverl sheets

A clinical study on subcutaneous breast insertion of tissue expanders using Neoverl sheets - A clinical study on subcutaneous breast insertion of tissue expanders using Neoverl sheets

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000057331
Enrollment
120
Registered
2025-03-18
Start date
2025-03-20
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

breast cancer

Interventions

Patients with a subcutaneous tissue thickness of at least 1 cm, no problems with breast skin blood flow on intraoperative ICG examination, and no plans for postoperative radiation therapy will be incl
the TE is inserted under the dissected pectoralis major muscle, and the lateral and caudal portions are covered with a Neover Sheet. The anterior sheath and anterior serratus fascia are not dissected

Sponsors

Toyama University
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Adult female patients Patients with primary breast cancer who are scheduled to undergo TE insertion and whose breast skin thickness after breast cancer resection is 0.5 mm or more and who have no skin blood flow problem, and patients whose breast is less than 0.5 mm or who have breast skin blood flow problem but for whom full TE coverage with pectoralis major muscle is difficult, or who have a history of infection, radiation, or breast surgery Patients who have a history of infection, irradiation, or breast surgery and are scheduled to undergo TE insertion for breast reconstruction in the future. Patients who have received a full explanation of the study based on the same document and who have fully understood it, and who have given their consent to participate in the study of their own free will.

Exclusion criteria

Exclusion criteria: Patients receiving steroids or immunosuppressive drugs for other diseases on a continuous basis Patients with poorly controlled diabetes mellitus Smokers Obesity patients with a BMI of 25 or more Other patients whom the investigator deems inappropriate to participate in the study.

Design outcomes

Primary

MeasureTime frame
Tissue expanders extraction rate within 6 months after surgery

Countries

Japan

Contacts

Public ContactKahori Tsukura

Toyama University Hospital Plastic Reconstructive and Aesthetic Surgery

ktsukura73tyrd@gmail.com0764342315

Outcome results

None listed

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