The New Fabric for Sling Method in Expander-Implant ...
Transcript of The New Fabric for Sling Method in Expander-Implant ...
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The New Fabric for Sling Method in Expander-Implant Immediate
Breast Reconstruction
Plastic and Reconstructive SurgeryOkayama university hospital
Satoko WatanabeYoshihiro Kimata
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COI Disclosure Information
I have the following financial relationship to disclose.ü In-kind support for this activity from
GUNZE medical division
Lead PresenterSatoko Watanabe
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Background
There have been several kinds of devices used for sling method in immediate two-stage breast reconstruction with tissue expander (TE).
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ObjectThis presentation is to show a prospective study protocol for assessment of the new bioabsorbable polyglycolic acid (PGA) felt to adapt for immediate two-stage breast reconstruction based on TE with sling method.
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Materials and Methods
• The PGA felt (NEOVEIL sheet ,GUNZE medical division, Japan) was developed as a scaffold on regenerative medicine.
• This product is commonly used for reinforcing to the suturing partin other surgery.
• This sheet will be absorbed within 15 weeks after implantation.
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Materials and MethodsPGA felt was adapted to cover TE in lower lateral pole of breast at first stage.
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Participantü Informed concent was available.ü Primary breast cancer patientü Immediate two-stage breast
reconstruction with TE following mastectomy
ü January 2010 – September 2011ü Target sample size 30
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Outcome• Primary outcome
Incidence of implant losswithin 30 days after surgery.
• Secondary outcome - Incidence of any adverse event - Postoperative pain- Patient-reported outcome (PRO)- Aesthetic outcome. - Histology of soft tissue around TE
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Inclusion criteria
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Study FlowInformed consent
Enrollment
Two-staged reconstruction with TE using PGA felt
Exchange to implant
Poor skin viability
Excluded
Following up and assessment at 1 month and 3, 6, 12months
ExpansionAdjuvant therapy TE without PGA felt
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Advantage
• Low cost• Soft texture• High biocompatibility• Proven safety for several decades
in other surgery
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Disadvantage
• Inflammatory reaction at early stage during absorption
• Lack of evidence on breast reconstruction
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Limitation
This study is not randomized control trial, but prospective observational study in a single-center.