The study of assessing the safety of NEOVEIL sheet in immediate two-stage tissue expander/implant breast reconstruction.

The study of assessing the safety of NEOVEIL sheet in immediate two-stage tissue expander/implant breast reconstruction. - The study of assessing the safety of NEOVEIL sheet in immediate two-stage tissue expander/implant breast reconstruction.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000018644

Enrollment

Registered

2015-08-11

Start date

2015-02-17

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

Using NEOVEIL sheet in immediate two-stage tissue expander/implant breast reconstruction.

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Patients are scheduled skin sparing mastectomy or nipple sparing mastectomy and immediate two-stage tissue expander/implant reconstruction Non obesity Non severe breast ptosis Non smoker Patients who received imformed concent and gained agreement by signature.

Exclusion criteria

Exclusion criteria: Inflammatory cancers Patients who had recieved radiation therapy before mastectomy. Patients who take steroids. Patients who have endocrine disorder. (including diabetes mellitus) Patients with a history of collagen disease. When the doctor considers the patient is not appropriate.

Design outcomes

Primary

Measure	Time frame
Acute removal rate of expander/implant .	—

Secondary

Measure	Time frame
Acute postoperative complication rate Cosmetic outcome following breast reconstruction Patient reported outcome	—

Countries

Japan

Contacts

Public ContactSatoko Watanabe

Okayama University Hospital Department of plastic surgery

pnd689oi@okayama-u.ac.jp086-235-7214

Outcome results

None listed

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