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Not Yet Recruiting NCT07670754

ORASIS in Breast Reconstruction

Conditions: DIEP Flap, Breast Reconstruction, Breast Cancer

Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 30
Sponsor: Duke University

Location: Duke University Medical Center Durham North Carolina

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 Criteria

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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07670754). StuddyBuddy aggregates publicly available trial information.