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ORASIS in Breast Reconstruction

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests ORASIS during DIEP flap breast reconstruction, which uses tissue from the belly to rebuild a breast. It looks at whether ORASIS helps surgeons join tiny blood vessels faster and more precisely, with fewer stops to rinse or suction the area. It is for women age 18 or older having breast reconstruction after breast removal to treat or prevent cancer.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Women having DIEP flap surgery to rebuild a breast that was removed by mastectomy. One or both breasts may have been removed.
  • The breast was removed to treat cancer or help prevent it.
  • Breast reconstruction may happen right after breast removal or later.
  • Age 18 or older when agreeing to join the study and when having DIEP flap surgery.

Who can't join

  • Any past breast reconstruction or placement of a tissue expander, a device that stretches skin, in the breast being rebuilt.
  • Having DIEP flap surgery for a reason other than rebuilding a breast removed to treat or prevent cancer.
  • Under age 18 when agreeing to join the study or when having DIEP flap surgery.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (2)

NC