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ORASIS in Breast Reconstruction

2026年6月29日 更新者：Duke University

ORASIS and Microsurgical Anastomosis Outcomes in DIEP Flap Breast Reconstruction: A Crossover Randomized Controlled Trial

The purpose of this study is to assess the use of ORASIS during microsurgical anastomosis formation in Deep Inferior Epigastric Perforator (DIEP) flap breast reconstruction and its potential effects on surgical precision, surgeon efficiency, and anastomosis outcomes. The investigators hypothesize that the use of ORASIS will decrease the amount of time needed to perform microsurgical anastomoses, reduce interruptions for irrigation and suction, and increase the quality of anastomoses in DIEP flap breast reconstruction.

調査の概要

状態

まだ募集していません

条件

介入・治療

研究の種類

介入

入学 (推定)

30

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

研究場所

  • アメリカ
    • North Carolina
      • Durham、North Carolina、アメリカ、27710
        • Duke University Medical Center
        • コンタクト：
      • Raleigh、North Carolina、アメリカ、27609
        • Duke Raleigh Hospital
        • コンタクト：

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

Inclusion:

  • Female Deep Inferior Epigastric Perforator (DIEP) flap breast reconstruction patients who have received a prior mastectomy (either unilateral or bilateral) on the breast undergoing reconstruction
  • Patients who received mastectomies for oncologic or prophylactic indications
  • Patients receiving either immediate or delayed DIEP flap breast reconstruction
  • Age 18 or older at the time of patient consent and DIEP flap surgery

Exclusion:

  • History of any prior tissue expander placement or breast reconstruction on the breast undergoing DIEP flap reconstruction
  • Patients receiving DIEP flap breast reconstruction for indications other than oncologic or prophylactic post-mastectomy breast reconstruction
  • Under the age of 18 at the time of patient consent or DIEP flap surgery

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：クロスオーバー割り当て
  • マスキング：独身

武器と介入

参加者グループ / アーム
介入・治療
介入なし：Control Arm
In the control arm, surgeons will perform two microsurgical anastomoses without the use of ORASIS in either bilateral or unilateral Deep Inferior Epigastric Perforator (DIEP) flap reconstruction. If bilateral DIEP flap reconstruction is performed in the control arm, only the first microsurgical anastomosis for each bilateral DIEP flap reconstruction will be assessed. In both study arms, surgeons will perform end-to-end anastomosis using current standard-of-care techniques. This will include the formation of anastomoses between the deep inferior epigastric artery (DIEA) perforators and internal mammary artery (IMA) in the antegrade direction of blood flow using 8-0 nylon sutures, as well as the deep inferior epigastric vein (DIEV) perforators and internal mammary vein (IMV).
実験的：ORASIS Arm
In the ORASIS arm, surgeons will perform two microsurgical anastomoses with the use of ORASIS in either bilateral or unilateral Deep Inferior Epigastric Perforator (DIEP) flap reconstruction. If bilateral DIEP flap reconstruction is performed in the treatment arm, ORASIS will only be used in the first microsurgical anastomosis performed in each bilateral DIEP flap reconstruction; only the breast reconstructed with the use of ORASIS will be assessed. In both study arms, surgeons will perform end-to-end anastomosis using current standard-of-care techniques. This will include the formation of anastomoses between the deep inferior epigastric artery (DIEA) and internal mammary artery (IMA) in the antegrade direction of blood flow using 8-0 nylon sutures, as well as the deep inferior epigastric vein (DIEV) perforators and internal mammary vein (IMV).
デバイス：Use of ORASIS Device
The study intervention is the use of the ORASIS device during Deep Inferior Epigastric Perforator (DIEP) flap breast reconstruction. ORASIS is a dual irrigation and suction device that can be placed in the surgical field during the formation of microsurgical anastomoses. The device was previously registered with the Food and Drug Administration (FDA) under registration number 878.4200; the device is currently not registered with the FDA as it is pending renewal. The device is manufactured by a partner company (Spectroplast/Ricoh UK) with compliance to international quality standards. The manufacturer has successfully implemented the ISO 9001 Quality Management System across operational areas following a comprehensive audit process that supports compliance with FDA Current Good Manufacturing Practice (cGMP) requirements (21 CFR Part 820) for Class I medical devices. Spectroplast/Ricoh UK is certified under FDA ISO 10993 standards for biological evaluation of medical devices.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Mean anastomosis time (minutes)
時間枠：From first suture placement to anastomosis completion
Total anastomosis time will be defined as the number of minutes from first suture placement to anastomosis completion.
From first suture placement to anastomosis completion
Mean ischemia time (minutes)
時間枠：From pedicle transection to anastomosis completion
Total ischemia time will be defined as the number of minutes from flap division to flap reperfusion.
From pedicle transection to anastomosis completion

二次結果の測定

結果測定
メジャーの説明
時間枠
Mean number of interruptions per procedure
時間枠：From beginning of microsurgical anastomosis to end of microsurgical anastomosis
Interruptions will be defined as instances where the surgeon pauses for suction/irrigation in the control arm vs. automatic suction/irrigation in the ORASIS arm.
From beginning of microsurgical anastomosis to end of microsurgical anastomosis
Surgeon Survey
時間枠：Within 1 month after conclusion of DIEP flap surgery procedure
A post-procedure survey (Likert scale) will be administered after each procedure assessing ease of use, surgeon perception of precision, and overall satisfaction with the ORASIS device.
Within 1 month after conclusion of DIEP flap surgery procedure
Incidence of postoperative complications 0-48 hours after procedure
時間枠：Within 48 hours after DIEP flap surgery
Notable complications include flap failure, re-operation/take-back and wound dehiscence, seroma, hematoma, and surgical site infection.
Within 48 hours after DIEP flap surgery
Mean NASA-TLX (Task Load Index) score
時間枠：From beginning of microsurgical anastomosis to end of microsurgical anastomosis
The NASA Task Load Index (NASA-TLX) is a validated tool to measure cognitive and physical workload for surgeons, reported as a score between 0 to 100.
From beginning of microsurgical anastomosis to end of microsurgical anastomosis
Mean Surgical Assessment Metric Scale (SAMS) overall scores
時間枠：From beginning of microsurgical anastomosis to end of microsurgical anastomosis
The Surgical Assessment Metric Scale (SAMS) is a validated tool that assesses proficiency across key technical metrics such as suture placement, knot quality, and overall flow of the procedure on a scale of 1-5. Performed anastomoses will be recorded by the digital microscope, and the quality and precision of the anastomosis will be assessed by a blinded rater using the previously validated SAMS score checklist.
From beginning of microsurgical anastomosis to end of microsurgical anastomosis

その他の成果指標

結果測定
メジャーの説明
時間枠
Number of surgeons per case
時間枠：During the entirety of the DIEP flap procedure
Number of surgeons per case, stratified by level of training (i.e. 1 vs 2 microsurgeons required +/- residents). For example, allowing a microsurgeon to perform the anastomosis alone as opposed to a co-surgeon case would reduce operative costs.
During the entirety of the DIEP flap procedure
Estimated cost difference per case (economic impact metrics)
時間枠：During the entirety of the DIEP flap procedure
Based on average operating room (OR) time cost for plastic surgery procedures at Duke (dollars per minute).
During the entirety of the DIEP flap procedure

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Duke University

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年12月1日

一次修了 (推定)

2027年12月1日

研究の完了 (推定)

2027年12月1日

試験登録日

最初に提出

2026年6月22日

QC基準を満たした最初の提出物

2026年6月22日

最初の投稿 (実際)

2026年6月26日

学習記録の更新

投稿された最後の更新 (実際)

2026年7月1日

QC基準を満たした最後の更新が送信されました

2026年6月29日

最終確認日

2026年6月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • Pro00118006

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

IPD プランの説明

Confidentiality of subject data will be ensured by de-identification of subject data. During data collection, subject identifiers and relevant data elements will be recorded in the database. Then, study-specific identification numbers will be assigned to each subject. Prior to dissemination of any information in this database beyond the DUMC's secure servers or firewall, all identifiers will be stripped from the database and data will only be referenced by the study-specific identification numbers.

The adequacy of the Duke Research Data Lifecycle will be evaluated and approved by the Surgery CRU and IT personnel prior to study conduct. Any publications or presentations that result from this research will not identify any subjects individually and will present data in aggregate form only. Data collected as part of this study will not be submitted to the FDA; data collected will only be used for publication as part of an assessment of device efficacy.

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

はい

米国で製造され、米国から輸出された製品。

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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