Clinical trials: DIEP Flap
DIEP Flap, Breast Reconstruction
ORASIS in Breast Reconstruction
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…
- Conditions
- DIEP Flap, Breast Reconstruction, Breast Cancer
- Trial name
- NCT07670754
- Testing
- Use of ORASIS Device
- Where
- 2 sites in United States
- Volunteers
- 30 people
- Sponsor
- Duke University
Breast Cancer
CT-Angiography Prior to DIEP Flap Breast Reconstruction
This study will Investigate whether or not preoperative computed tomography (CT) angiography will lower operative times and post operative complications for breast reconstruction performed with a deep inferior epigastric artery…
- Trial name
- NCT02883387
- Testing
- Preoperative CT angiography, No Preoperative Imaging
- Where
- United States
- Volunteers
- 39 people
- Sponsor
- University of Colorado, Denver
Breast Neoplasms, Ischemia-Reperfusion Injury
DIEP Flap Breast Reconstruction: Perioperative Biomarkers and Outcomes
Brief Summary This observational study will follow patients who undergo DIEP flap breast reconstruction to better understand a common surgical challenge called ischemia-reperfusion (I/R) injury.
- Conditions
- Breast Neoplasms, Ischemia-Reperfusion Injury, Postoperative Complications, Wound Healing
- Trial name
- NCT07263347
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Hubei Cancer Hospital
Breast Neoplasms, Breast Reconstruction
DIEP-MDS for Risk Stratification of Flap Vascular Compromise and Failure in Breast Reconstruction
This multicenter retrospective observational study will develop and validate a CTA-based quantitative risk score-the DIEP Morphological Deviation Score (DIEP-MDS)-to estimate the risk of flap-related vascular compromise and flap…
- Conditions
- Breast Neoplasms, Breast Reconstruction, Postoperative Complications
- Trial name
- DIEP-MDS (NCT07761390)
- Where
- 20 sites in China
- Volunteers
- 1,500 people
- Sponsor
- Zhuliling
Breast Cancer, Breast Reconstruction
Sensory Restoration After DIEP Flap Neurotization
Common goals of breast reconstruction include obtaining satisfactory breast symmetry, softness, and appropriate size and shape. Advances in surgical techniques have prompted a new goal: achieving breast sensation after…
- Conditions
- Breast Cancer, Breast Reconstruction, Sensory Restoration
- Trial name
- NCT04533373
- Testing
- DIEP Flap Neurotization
- Where
- United States
- Volunteers
- 156 people
- Sponsor
- Johns Hopkins University
Arterial Hypotension
Effect of Phenylephrine Versus Norepinephrine on Venous Return
Induction of general anesthesia often induces a decrease in the mean arterial blood pressure (MAP) caused by arterial and venous dilatation.
- Trial name
- NCT03872570
- Testing
- Phenylephrine, Norepinephrine
- Where
- Belgium
- Volunteers
- 40 people
- Sponsor
- Algemeen Ziekenhuis Maria Middelares
Breast Reconstruction, Anesthesia
Comparing Local Anesthetics for TAP Block During Abdominally-based Free Flap for Breast Reconstruction
This study will compare the efficiency of transversus abominus plane (TAP) block using liposomal bupivacaine versus plain bupivacaine that is administered in the operating room under ultrasound guidance prior to the in patients…
- Conditions
- Breast Reconstruction, Anesthesia, Transverse Abdominis Plane Block
- Trial name
- NCT03700970
- Testing
- Liposomal bupivacaine, Regular bupivacaine
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Vanderbilt University Medical Center
Hypotension During Surgery
Goal-directed Fluid Therapy During Deep Inferior Epigastric Perforator (DIEP) Free Flap Breast Reconstruction
Adequate free flap perfusion during Deep Inferior Epigastric Perforator (DIEP) flap breast reconstruction surgery requires maintaining blood pressure above 100 mmHg and avoiding excessive fluid administration.
- Trial name
- GDFT DIEP-flap (NCT06080178)
- Testing
- Plasma-lyte (static group), Norepinephrine (static group), Plasma-lyte (dynamic group)
- Where
- Belgium
- Volunteers
- 82 people
- Sponsor
- Algemeen Ziekenhuis Maria Middelares
Mammaplasty
A Bilateral Interconnected DIEP Flap Based on One Vessel Pedicle for Breast Reconstruction
Bilateral DIEP flap needs two groups of vessel pedicles. We suppose that the bilateral DIEP flap may survive on one vessel pedicle by means of interconnection of bilateral DIEA.
- Trial name
- NCT00514748
- Testing
- DIEP, Interconnected DIEP
- Where
- China
- Sponsor
- Chinese Academy of Sciences
Fat Necrosis
Indocyanine Green for Perfusion Assessment of DIEP Flaps
Currently during DIEP flap reconstruction, the perfusion of the flap is assessed by the clinical view of the surgeon. Identification of demarcated ischemic zones of the DIEP flap could be optimized by using fluorescence imaging…
- Trial name
- FAFI (NCT05507710)
- Testing
- Near-infrared fluorescence imaging of perfusion
- Where
- 2 sites in Netherlands
- Volunteers
- 280 people
- Sponsor
- Leiden University Medical Center
Breast Cancer
BENEFIT OF MECHANICAL ISCHEMIC PRECONDITIONING ON TOLERANCE OF ADIPOSE TISSUE TO ISCHEMIA REPERFUSION OF TYPE DIEP (DEEP INFERIOR EPIGASTRIC PERFORATOR) FREE FLAPS.
Breast cancer is the most common cancer amongst women in terms of frequency, with more than 50 000 newly diagnosed cases per year in France. The average 5-year survival rate for women with breast cancer is around 85%.
- Trial name
- PRIMIDIEP (NCT05373069)
- Testing
- Mechanical ischemic preconditioning of diep-type flap
- Where
- France
- Volunteers
- 18 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Breast Cancer
WashU DIEP Flap Video and Patient Understanding Improvement
Patients will complete a survey before and after watching the WashU DIEP Flap Video at their pre-operative standard of care visit, and a third survey at their post-operative standard of care visit.
- Trial name
- NCT06864754
- Testing
- WashU DIEP Flap Video
- Where
- United States
- Volunteers
- 300 people
- Sponsor
- Washington University School of Medicine
Sensitisation
DIEP (Deep Inferior Epigastric Artery Perforator) Flap Sensory Recovery Following Neurotization
The purpose of this study is to compare the sensory return of DIEP flaps with nerve connection to DIEP flaps with no nerve connection to see which is better.
- Trial name
- NCT04818190
- Testing
- Sensory neurotization
- Where
- Canada
- Volunteers
- 30 people
- Sponsor
- University of Manitoba
Deep Inferior Epigastric Perforator Flap Reconstruction
Case Series Comparing Drains to TissuGlu® in a Donor Site DIEP Flap Breast Reconstruction Procedure
To evaluate the safety and effectiveness of a lysine-derived urethane adhesive (TissuGlu® Surgical Adhesive) as a less invasive alternative to surgical drains in the abdominal donor site for deep inferior epigastric perforator…
- Trial name
- NCT03481140
- Testing
- TissuGlu Surgical Adhesive
- Volunteers
- 58 people
- Sponsor
- Cohera Medical, Inc.
Breast Reconstruction
Impact of Drainless Donor Abdominal Site in Deep Inferior Epigastric Perforator (DIEP) Flap on Complications and Duration of Hospital Stay.
Inserting surgical drains is an ancient approach used across different specialties because of its many advantages such as discharge of fluid accumulation, appraising and qualifying drain capacities, lowering infection…
- Trial name
- NCT06468488
- Testing
- DIEP flap surgery without drain, DIEP flap surgery with drains
- Where
- Belgium
- Volunteers
- 150 people
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
Breast Cancer
Preoperative Imaging in DIEP Flap Breast Reconstruction
The purpose of this study is to determine whether preoperative abdominal imaging using either CT angiogram (CTA), or MR angiogram (MRA) will impact perforator dissection time, cost, and patient outcomes in DIEP flap breast…
- Trial name
- NCT02111239
- Testing
- CTA, MRA
- Where
- Canada
- Volunteers
- 60 people
- Sponsor
- Sunnybrook Health Sciences Centre
Breast Cancer
The Effects of Indocyanine Green Angiography (IGA) on Deep Inferior Epigastric Artery Perforator (DIEP) Flap Design and Post-Operative Fat Necrosis
The aim of this study is to prospectively evaluate the effect of intra-operative Indocyanine green angiography (IGA) on both flap design and rate of post-operative fat necrosis in patients undergoing autologous breast…
- Trial name
- SPY (NCT02144961)
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- University of Washington
Reconstructive Surgery, Flap Monitoring
Flap Assessment With Regional Oximetry for Early Detection of Compromise in Free Flap Reconstructive Surgery - FLARE Study
After some operations in which tissue is removed, it is necessary to repair the defect with a piece of tissue from another location in the body.
- Trial name
- FLARE (NCT07887256)
- Testing
- Elective free flap surgery, INVOS monitoring
- Where
- 3 sites in Netherlands
- Volunteers
- 100 people
- Sponsor
- Leiden University Medical Center
Breast Cancer, Perforator Flap
Deep Inferior Epigastric Artery Flap for Breast Reconstruction
Background: There is no consensus on the duration of prophylactic antibiotics for autologous breast reconstruction after mastectomy.
- Conditions
- Breast Cancer, Perforator Flap, Anti-Infectives Adverse Reaction, Infections
- Trial name
- NCT05088239
- Testing
- prophylactic antibiotics duration
- Volunteers
- 108 people
- Sponsor
- Chiayi Christian Hospital
Breast Cancer
Sensory Nerve Coaptation in DIEP Flap Breast Reconstruction
Restoring the sensation of the breast becomes increasingly recognized as a critical part of autologous breast reconstruction. A prospective study was conducted of all patients who underwent either innervated or non-innervated…
- Trial name
- NCT04093999
- Testing
- Sensory nerve coaptation
- Where
- Netherlands
- Volunteers
- 126 people
- Sponsor
- Maastricht University Medical Center