Breast Cancer, Breast Reconstruction, DIEP Flap
Conditions
Keywords
DIEP Flap, Breast Reconstruction, Breast Cancer
Brief summary
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.
Interventions
DEVICEUse 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.
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean anastomosis time (minutes) | 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. |
| Mean ischemia time (minutes) | From pedicle transection to anastomosis completion | Total ischemia time will be defined as the number of minutes from flap division to flap reperfusion. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean number of interruptions per procedure | 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. |
| Mean NASA-TLX (Task Load Index) score | 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. |
| Mean Surgical Assessment Metric Scale (SAMS) overall scores | 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. |
| Surgeon Survey | 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. |
| Incidence of postoperative complications 0-48 hours after procedure | 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. |
Countries
United States
Contacts
CONTACTJoey Liang
CONTACTAsh Patel, MB ChB
Outcome results
None listed