Menu
Not yet recruiting NCT07670754

ORASIS in Breast Reconstruction

No phase Interventional DIEP Flap Breast Reconstruction Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Use of ORASIS Device.
Who it may be relevant to
Registry conditions: DIEP Flap, Breast Reconstruction, Breast Cancer. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • Device Use 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 p

Primary outcome measures

  • Mean anastomosis time (minutes) [Time frame: From first suture placement to anastomosis completion]
  • Mean ischemia time (minutes) [Time frame: From pedicle transection to anastomosis completion]
Secondary outcome measures (5)
  • Mean number of interruptions per procedure [Time frame: From beginning of microsurgical anastomosis to end of microsurgical anastomosis]
  • Mean NASA-TLX (Task Load Index) score [Time frame: From beginning of microsurgical anastomosis to end of microsurgical anastomosis]
  • Mean Surgical Assessment Metric Scale (SAMS) overall scores [Time frame: From beginning of microsurgical anastomosis to end of microsurgical anastomosis]
  • Surgeon Survey [Time frame: Within 1 month after conclusion of DIEP flap surgery procedure]
  • Incidence of postoperative complications 0-48 hours after procedure [Time frame: Within 48 hours after DIEP flap surgery]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 2 centers
  • Duke University Medical Center — Durham
  • Duke Raleigh Hospital — Raleigh

Identifiers

NCT: NCT07670754 · Pro00118006

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗