Clinical trial · Interventional
ORASIS in Breast Reconstruction
ORASIS and Microsurgical Anastomosis Outcomes in DIEP Flap Breast Reconstruction: A Crossover Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Breast Reconstruction | — | UNRESOLVED | — |
| DIEP Flap | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Use of ORASIS Device | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Control Arm
- description
- In the control arm, surgeons will perform two microsurgical anastomoses without the use of ORASIS in either bilateral or unilateral Deep Inferior Epigastric Perforator (DIEP) flap reconstruction. If bilateral DIEP flap reconstruction is performed in the control arm, only the first microsurgical anastomosis for each bilateral DIEP flap reconstruction will be assessed. In both study arms, surgeons will perform end-to-end anastomosis using current standard-of-care techniques. This will include the formation of anastomoses between the deep inferior epigastric artery (DIEA) perforators and internal mammary artery (IMA) in the antegrade direction of blood flow using 8-0 nylon sutures, as well as the deep inferior epigastric vein (DIEV) perforators and internal mammary vein (IMV).
- type
- EXPERIMENTAL
- label
- ORASIS Arm
- description
- In the ORASIS arm, surgeons will perform two microsurgical anastomoses with the use of ORASIS in either bilateral or unilateral Deep Inferior Epigastric Perforator (DIEP) flap reconstruction. If bilateral DIEP flap reconstruction is performed in the treatment arm, ORASIS will only be used in the first microsurgical anastomosis performed in each bilateral DIEP flap reconstruction; only the breast reconstructed with the use of ORASIS will be assessed. In both study arms, surgeons will perform end-to-end anastomosis using current standard-of-care techniques. This will include the formation of anastomoses between the deep inferior epigastric artery (DIEA) and internal mammary artery (IMA) in the antegrade direction of blood flow using 8-0 nylon sutures, as well as the deep inferior epigastric vein (DIEV) perforators and internal mammary vein (IMV).
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available