Clinical trials: Mammary Reconstruction
Venous Thromboembolism
Apixaban vs Enoxaparin Following Microsurgical Breast Reconstruction-An RCT
Subcutaneous enoxaparin is currently the gold standard for VTE chemoprophylaxis. However, the efficacy of chemoprophylaxis with subcutaneous enoxaparin is affected by patient-level factors, thus, resulting in VTE events despite…
- Trial name
- NCT04504318
- Testing
- Apixaban 2.5 MG Oral Tablet, Enoxaparin 40Mg/0.4mL Prefilled Syringe
- Where
- United States
- Volunteers
- 82 people
- Sponsor
- Stanford University
Other Reconstructive Surgery
Use of Pulsed Electromagnetic Fields (PEMF) After Breast Reconstruction Surgery
Pedicled transverse rectus abdominus myocutaneous (TRAM) flaps are the most common post-mastectomy breast reconstructive surgeries that utilize the patient's tissue.
- Trial name
- NCT01262599
- Testing
- Ivivi Torino II PEMF Device
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- Columbia University
Breast Cancer, Breast Cancer Female
Study of Nerve Block Pain Management in Patients Undergoing a Double Mastectomy With Immediate Reconstruction
The purpose of this study is to determine if the injection site or sites used for administering pain medication (nerve blocks) before a double mastectomy with immediate reconstruction with tissue expanders reduce the need for…
- Trial name
- NCT04016376
- Testing
- PVB Protocol, PECS-1, Serratus
- Where
- United States
- Volunteers
- 1,507 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
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
Postoperative Pain, Postoperative Nausea and Vomiting
Pre-op Paravertebral Blocks to Decrease Post-op Pain Following Mastectomy With Immediate Tissue Expander (TE) Reconstruction
Primary Objective To determine if post-operative static pain scores differ between women undergoing bilateral mastectomy followed by bilateral immediate tissue expander reconstruction randomized either to ropivacaine- (treatment)…
- Conditions
- Postoperative Pain, Postoperative Nausea and Vomiting, Quality of Life
- Trial name
- NCT02161705
- Testing
- Ropivacaine, Saline
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- Johns Hopkins University
Breast Cancer
Intraoperative Pathway in DIEP Flap Breast Reconstruction
Efficiency in the operating room can be difficult in long cases with multiple surgeons. We used a team based approach to develop an intraoperative pathway for microsurgical breast reconstruction with a deep inferior epigastric…
- Trial name
- NCT00543764
- Testing
- pathway
- Where
- United States
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Beth Israel Deaconess Medical Center
Pain, Postoperative
Pectoralis (II) Block With Liposomal Bupivacaine vs Bupivacaine for Breast Surgery
This is a randomized controlled pilot study evaluating length of pain control with either liposomal bupivacaine or with bupivacaine plus decadron after PEC II injection in patients having bilateral mastectomies with immediate…
- Trial name
- NCT03383198
- Testing
- Liposomal bupivacaine right injection, Liposomal bupivacaine left injection
- Where
- United States
- Volunteers
- 5 people, healthy volunteers welcome
- Sponsor
- Prisma Health-Upstate
Breast Cancer, Ductal Carcinoma
Nipple-Areola Complex (NAC) Irradiation After Nipple-Sparing Mastectomy and Reconstruction
The purpose of this research study is to see if a participant's nipple and areola can be safely preserved by adding radiation to these areas after a nipple-sparing mastectomy and immediate breast reconstruction.
- Trial name
- NCT01208974
- Testing
- Nipple-Sparing Mastectomy, Breast Reconstruction, Axillary Surgery
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- University of Miami
Breast Cancer
One-stage Breast Reconstruction Using Dermal Matrix/Implant Versus Two-stage Expander/Implant Procedure
Currently the two-stage tissue expander/implant (TE/I) technique is the standard breast reconstructive option for breast cancer patients selected for immediate, skin-sparing mastectomy.
- Trial name
- AllodermRCT (NCT00956384)
- Testing
- One-stage dermal matrix/implant procedure, Two-stage tissue expander/implant procedure
- Where
- 4 sites in Canada
- Volunteers
- 198 people, healthy volunteers welcome
- Sponsor
- University Health Network, Toronto
Breast Augmentation, Breast Reconstruction
Safety and Effectiveness of Style 410 Silicone-Filled Breast Implant Study
Safety and effectiveness of Style 410 Silicone-Filled Breast Implants in women undergoing primary augmentation, primary reconstruction, or revision of existing breast implants.
- Conditions
- Breast Augmentation, Breast Reconstruction, Revision of Augmentation or Reconstruction
- Trial name
- NCT00690339
- Testing
- Style 410 Silicone-Filled Breast Implants
- Where
- United States
- Volunteers
- 941 people, healthy volunteers welcome
- Sponsor
- Allergan Medical
Breast Augmentation, Breast Reconstruction
NATRELLE® 410 Full and Moderate Height/Projection Breast Implant Continued Access Post-Approval Study
Post-approval study of the safety and effectiveness of NATRELLE® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants (Styles 410 FM, FF, MM, or MF) for breast augmentation, reconstruction, or revision
- Conditions
- Breast Augmentation, Breast Reconstruction, Breast Implant Revision
- Trial name
- NCT01853605
- Testing
- Anatomically shaped silicone gel-filled breast implants
- Where
- United States
- Volunteers
- 3,811 people, healthy volunteers welcome
- Sponsor
- Allergan
Breast Cancer
Study of Radiation Fractionation on Patient Outcomes After Breast REConstruction (FABREC) for Invasive Breast Carcinoma
This study is a randomized trial of hypofractionation (short-course) radiation therapy versus conventional radiation therapy in women who have undergone mastectomy and immediate breast reconstruction.
- Trial name
- NCT03422003
- Testing
- Radiation Therapy
- Where
- 15 sites in United States
- Volunteers
- 400 people
- Sponsor
- Dana-Farber Cancer Institute
Pain, Breast
The Use Of Liposomal Bupivacaine For Pain Control
The purpose of this research study is to determine how well the local anesthetic, liposomal bupivacaine, controls postoperative pain after mastectomy and breast reconstruction.
- Trial name
- NCT03722927
- Testing
- Bupivacaine, Liposomal Bupivacaine
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Wake Forest University Health Sciences
Breast Reconstruction, Contour Irregularities
Immunophenotyping of Fresh Stromal Vascular Fraction From Adipose Derived Stem Cells (ADSC) Enriched Fat Grafts
The purpose of this study is to investigate if there is a relationship between the take of fat grafts with and without ADSCs and the presence of specific surface markers on the cells of the stromal vascular fraction.
- Conditions
- Breast Reconstruction, Contour Irregularities, Volume Insufficiency
- Trial name
- NCT01771913
- Testing
- centrifuged fat graft, ADSCs enriched fat graft
- Where
- Brazil
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- University of Sao Paulo
Breast Reconstruction, Breast Augmentation
Mentor MemoryGel Post-Approval Study
In November 2006, U.S. Food and Drug Administration (FDA) approved Mentor's MemoryGel silicone gel-filled breast implants for use in women who are undergoing primary or revisional breast augmentation and primary or revisional…
- Conditions
- Breast Reconstruction, Breast Augmentation, Breast Revision
- Trial name
- MGPAS (NCT00756652)
- Testing
- Mentor Silicone Gel-Filled Breast Implants, Saline Breast Implants
- Volunteers
- 42,491 people, healthy volunteers welcome
- Sponsor
- Mentor Worldwide, LLC
Breast Cancer
Comparison of One-port and Two-port Tissue Expanders for Breast Reconstruction
Appropriate patients undergoing going immediate breast reconstruction with tissue expanders following mastectomy will be randomized to receive one-port or two-ports tissue expanders.
- Trial name
- NCT02725801
- Testing
- Allergen one-port tissue expander placement, AlloX2 two-port tissue expander placement
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Lesley Wong
Breast Cancer
Optimizing Decision Making About Breast Reconstruction After Mastectomy: A Patient-Centered Approach
Although clinical decision tools (CDTs) exist for a variety of treatments, CDTs designed to support personalized breast reconstruction decisions, particularly about type and timing of reconstruction, are lacking.
- Trial name
- NCT03346161
- Testing
- Usual care American Society of Plastic Surgeons booklet "Breast Reconstruction", Decision tool, Usual Care Group - Outcome Measures
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- Washington University School of Medicine
Scar Formation
Study of GBT009 for Treatment of Incisional Wounds Following Breast Reconstruction Surgery
The primary objective of this study is to assess whether intradermal injections of GBT009 along full thickness incisions following surgery results in an improvement in scar appearance.
- Trial name
- NCT01053897
- Testing
- GBT009
- Where
- 2 sites in United States
- Volunteers
- 5 people
- Sponsor
- Garnet BioTherapeutics, Inc.
Breast Cancer
Selective Intraoperative Administration of Local Anesthesia in Breast Reconstruction
Subjects are being asked to participate in this study because they will be undergoing unilateral (one) or bilateral (two) mastectomy surgery with immediate reconstruction involving insertion of a tissue expander.
- Trial name
- NCT02525718
- Testing
- Saline, 0.25 % bupivacaine (2.5 mg/ml) w/ 1:100,000 epinephrine & 4 mg dexamethasone
- Where
- United States
- Volunteers
- 47 people
- Sponsor
- Northwestern University
Nonmalignant Breast Conditions, Breast Cancer
Trial of Drain Antisepsis After Tissue Expander Breast Reconstruction
Surgical site infection (SSI) after breast and axillary surgery occurs more often than for other clean surgical procedures. Infection in the setting of a tissue expander can be devastating and can lead to early implant loss and…
- Trial name
- NCT01286168
- Testing
- Sodium hypochlorite (Dakin's Solution), Chlorhexidine gluconate disk, Control
- Where
- 2 sites in United States
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- Mayo Clinic