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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Arm | No Intervention | 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). | |
| ORASIS Arm | Experimental | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Use of ORASIS Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean anastomosis time (minutes) | 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) | Total ischemia time will be defined as the number of minutes from flap division to flap reperfusion. | From pedicle transection to anastomosis completion |
| Measure | Description | Time Frame |
|---|---|---|
| Mean number of interruptions per procedure | 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 |
| Mean NASA-TLX (Task Load Index) score |
| Measure | Description | Time Frame |
|---|---|---|
| Estimated cost difference per case (economic impact metrics) | 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 |
| Number of surgeons per case |
Inclusion:
Exclusion:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joey Liang | Contact | 4252097705 | joey.liang@duke.edu | |
| Ash Patel, MB ChB | Contact | ash.patel@duke.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
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.
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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This crossover study will utilize two arms: a control arm without the use of ORASIS and a treatment arm with the use of ORASIS. Each surgeon will serve as their own control by performing two anastomoses without the use of ORASIS and two anastomoses with the use of ORASIS. The order of procedures with or without ORASIS use will be randomized to minimize bias due to learning or fatigue. Blinding is not possible due to the visible use of the ORASIS device in the treatment arm of the study.
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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 | 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 |
| Surgeon Survey | 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 | 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 |
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 |
| Duke Raleigh Hospital | Raleigh | North Carolina | 27609 | United States |
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| D017437 |
| Skin and Connective Tissue Diseases |