ORASIS in Breast Reconstruction

ConditionsDIEP Flap Breast Reconstruction Breast Cancer

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexFemale

Age18+

SponsorDuke University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Crossover

Treatments tested in this trial

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.

Treatment groups

30 Participants

are divided into 2 treatment groups

Group A: Control ArmNo intervention 0 interventions

Group B: ORASIS ArmExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Mean anastomosis time (minutes)

Total anastomosis time will be defined as the number of minutes from first suture placement to anastomosis completion.

Time frame

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.

Time frame

From pedicle transection to anastomosis completion

Secondary outcomes

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.

Time frame

From beginning of microsurgical anastomosis to end of microsurgical anastomosis

Mean NASA-TLX (Task Load Index) score

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.

Time frame

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.

Time frame

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.

Time frame

Within 1 month after conclusion of DIEP flap surgery procedure

Other outcomes

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).

Time frame

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.

Time frame

During the entirety of the DIEP flap procedure

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Duke University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: