TY - JOUR
T1 - The new bioabsorbable sheet for the sling method in immediate breast reconstruction with expander-implant
T2 - A study protocol for interventional prospective study
AU - Watanabe, Satoko
AU - Mukai, Yuko
AU - Kimata, Yoshihiro
N1 - Funding Information:
This study includes the following researchers: data collection and data management group, Ryoko Nakagiri and Miho Saiga; safety monitoring committee, Aya Ono, Shiro Hinotsu, shinji Ohtani and Kiyoshi Yamada. Yuko Mukai assisted in the preparation of the study protocol. Takayuki Iwamoto, Tadahiko Shien, Naruto Taira, Hiroyoshi Doihara, Yoshihiro Kimata approved the final version of the study protocol and agree to the accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. NEOVEIL sheets using in this study will be supported by GUNZE medical division and Kyoto Medical Planning.
Publisher Copyright:
© 2020 Nagoya University.
PY - 2020/2/1
Y1 - 2020/2/1
N2 - The popularity of a sling method using biomaterial sheets for immediate breast reconstruction based on prosthesis has been increasing in western countries. However, acellular dermal matrix, which is representative of the biomaterial sheet, is not available and the sling method also has not been accepted in Japan. We focused on a new bioabsorbable sheet (NEOVEIL sheet) as a substitute for the sling method and report a prospective study protocol to assess the safety and effectiveness of this material. This was an ongoing, single center, open-label, single-arm study. Inclusion criteria and exclusion criteria are defined restrictively. If the surgeon determined that the perfusion of skin envelope after mastectomy is poor, the surgical procedure can be modified and that patient was excluded from the study. The primary outcome was the incidence of tissue expansion or implant explantation occurring within 1 month after surgery. The secondary outcomes are as follows: (1) aesthetic outcome using a rating scale; (2) symmetry of the nipple areolar complex position; (3) patient reported outcomes using BREAST-Q; (4) pain intensity using the Visual Analog Scale; (5) histology of the capsule around the tissue expander; (6) inflation volume at the first stage and overall inflation time of expansion; and (7) other adverse events regarding the surgery. This study will determine the safety and effectiveness of the sling method using a NEOVEIL sheet in Japanese women.
AB - The popularity of a sling method using biomaterial sheets for immediate breast reconstruction based on prosthesis has been increasing in western countries. However, acellular dermal matrix, which is representative of the biomaterial sheet, is not available and the sling method also has not been accepted in Japan. We focused on a new bioabsorbable sheet (NEOVEIL sheet) as a substitute for the sling method and report a prospective study protocol to assess the safety and effectiveness of this material. This was an ongoing, single center, open-label, single-arm study. Inclusion criteria and exclusion criteria are defined restrictively. If the surgeon determined that the perfusion of skin envelope after mastectomy is poor, the surgical procedure can be modified and that patient was excluded from the study. The primary outcome was the incidence of tissue expansion or implant explantation occurring within 1 month after surgery. The secondary outcomes are as follows: (1) aesthetic outcome using a rating scale; (2) symmetry of the nipple areolar complex position; (3) patient reported outcomes using BREAST-Q; (4) pain intensity using the Visual Analog Scale; (5) histology of the capsule around the tissue expander; (6) inflation volume at the first stage and overall inflation time of expansion; and (7) other adverse events regarding the surgery. This study will determine the safety and effectiveness of the sling method using a NEOVEIL sheet in Japanese women.
KW - Biomaterial
KW - Immediate breast reconstruction
KW - Prospective study
KW - Sling method
KW - Tissue expander
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U2 - 10.18999/nagjms.82.1.39
DO - 10.18999/nagjms.82.1.39
M3 - Article
C2 - 32273631
AN - SCOPUS:85085745762
VL - 82
SP - 39
EP - 45
JO - Nagoya Journal of Medical Science
JF - Nagoya Journal of Medical Science
SN - 0027-7622
IS - 1
ER -