ORASIS in Breast Reconstruction

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 DIEP (Deep Inferior Epigastric Perforator) 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Breast Cancer; Breast Reconstruction; DIEP Flap
• Intervention / Treatment: Device: Use of ORASIS Device

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Joey Liang; Phone Number: 4252097705; Email: joey.liang@duke.edu
• Study Contact Backup: Name: Ash Patel, MB ChB; Email: ash.patel@duke.edu

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
      • Contact: Joey Liang; Phone Number: 425-209-7705; Email: joey.liang@duke.edu
    • Raleigh, North Carolina, United States, 27609
      • Duke Raleigh Hospital
      • Contact: Joey Liang; Phone Number: 425-209-7705; Email: joey.liang@duke.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion:

• Female 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Arm; In the control arm, surgeons will perform two microsurgical anastomoses without the use of ORASIS in either bilateral or unilateral 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) and internal mammary artery (IMA) in the antegrade direction of blood flow using 8-0 nylon sutures.
Experimental: ORASIS Arm; In the ORASIS arm, surgeons will perform two microsurgical anastomoses with the use of ORASIS in either bilateral or unilateral 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.	Device: Use of ORASIS Device; The study intervention is the use of the ORASIS device during microsurgical anastomosis formation in DIEP flap breast reconstruction procedures. 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 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 demonstrated compliance to international quality standards. The manufacturer has successfully implemented the ISO 9001 Quality Management System across all operational areas following a comprehensive audit process, that supports compliance with FDA 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	The 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	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Estimated cost difference per case (economic impact metrics)	Based on average 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	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

Collaborators and Investigators

• Sponsor: Duke University

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: June 22, 2026
• First Submitted That Met QC Criteria: June 22, 2026
• First Posted (Actual): June 26, 2026

Study Record Updates

• Last Update Posted (Actual): June 26, 2026
• Last Update Submitted That Met QC Criteria: June 22, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Breast Cancer; Breast Reconstruction; DIEP Flap
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: Pro00118006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No