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

Summary

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.

Eligibility

Age range

18+ years

Sex

Female

Healthy volunteers

No

Interventions

• 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.

Locations (2)