Clinical trials: Mammary Reconstruction
Mastectomy and Breast Reconstruction
Efficacy Study of Single Stage Breast Reconstruction in Female Participants With Mastectomy
The purpose of this study was to compare the efficacy of immediate single-stage post-mastectomy breast reconstruction with Strattice Reconstructive Tissue Matrix (Strattice) as compared to immediate two-stage post-mastectomy…
- Trial name
- ESSBR (NCT01910298)
- Testing
- Breast Reconstruction, Direct to Implant (DTI) with Strattice™, Two Stage Breast Reconstruction
- Where
- 18 sites in France, Germany and 1 more
- Volunteers
- 131 people
- Sponsor
- LifeCell
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
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
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
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
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 Reconstruction
Becker Continued Access Study
While Core Becker patient follow-up is being completed this Continued Access Study is designed to enroll patients at a limited rate per month to allow for continued physician and patient experience with the device.
- Trial name
- NCT01286870
- Testing
- Mentor Becker 25 Expander/Breast Implant, Mentor Becker 50 Expander/Breast Implant
- Where
- United States
- Volunteers
- 11 people
- 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
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
Surgery, Breast Reconstruction
Impact of the Serratus Plane Block in Pain and the Use of Opioids in Breast Surgery
The purpose of this project is to evaluate the analgesic efficacy of a regional anesthesia technique ( interfascial block at the serratus muscle) performed in patient undergoing breast surgery and the effect of this technique on…
- Trial name
- NCT02905149
- Testing
- Serrato, Control
- Where
- Spain
- Volunteers
- 60 people
- Sponsor
- Instituto de Investigacion Sanitaria La Fe
Breast Cancer
Use of Dermal Matrix in Breast Reconstruction
We propose to evaluate the question of whether there is a significant difference between the traditional method of serratus flap tissue expander reconstruction and the acellular matrix method.
- Trial name
- NCT00692692
- Testing
- DermaMatrix, standard of care tissue expander breast reconstruction surgery after mastectomy
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- Vanderbilt University
Breast Reconstruction
The SERI® Surgical Scaffold Use in Reconstruction Post Market Study for Tissue Support and Repair in Breast Reconstruction Surgery
The purpose of the study is to obtain clinical experience with the use of SERI® Surgical Scaffold for tissue support and repair in breast reconstruction.
- Trial name
- NCT01256502
- Testing
- SERI® Surgical Scaffold
- Where
- United States
- Volunteers
- 160 people
- Sponsor
- Sofregen Medical, Inc.
Soft Tissue Support and Repair
The SeriScaffold® Use in Reconstruction Post Market Study for Tissue Support and Repair in Breast Reconstruction Surgery in Europe
This is a post-market study of the use of SeriScaffold® for soft tissue support and repair in breast reconstruction surgery.
- Trial name
- NCT01389232
- Testing
- SeriScaffold® Surgical Scaffold
- Where
- 5 sites in Germany, Italy and 2 more
- Volunteers
- 104 people
- Sponsor
- Sofregen Medical, Inc.
Breast Augmentation, Breast Reconstruction
Safety and Effectiveness of NATRELLE® 410 Highly Cohesive, Anatomically Shaped, Silicone-filled X-Style and L-Style Breast Implants
This is a prospective, multicenter study of the safety and effectiveness of NATRELLE® 410 Highly Cohesive, Anatomically Shaped, Silicone-Filled X-Style and L-Style Breast Implants.
- Conditions
- Breast Augmentation, Breast Reconstruction, Breast Implant Revision
- Trial name
- NCT01785069
- Testing
- Anatomically shaped, silicone-filled breast implants with low projection or extra-full projection
- Where
- 29 sites in United States
- Volunteers
- 355 people, healthy volunteers welcome
- Sponsor
- Allergan
Ductal Breast Carcinoma, Invasive Breast Carcinoma
Hypofractionated Radiation Therapy After Mastectomy in Preventing Recurrence in Patients With Stage IIa-IIIa Breast Cancer
This randomized phase III trial studies how well hypofractionated radiation therapy works in preventing recurrence in patients with stage IIa-IIIa cancer who have undergone mastectomy.
- Conditions
- Ductal Breast Carcinoma, Invasive Breast Carcinoma, Lobular Breast Carcinoma, Medullary Breast Carcinoma
- Trial name
- NCT03414970
- Testing
- Radiation Therapy, Questionnaire Administration, Quality-of-Life Assessment
- Where
- 859 sites in United States, Canada
- Volunteers
- 898 people
- Sponsor
- Alliance for Clinical Trials in Oncology
Breast Cancer
Bioprosthetic Mesh to Expand the Lower Pole in Tissue Expander Reconstruction
The goal of this clinical research study is to learn if the complication rate and post-surgical appearance differ based on what type of mesh is used for breast reconstruction surgery.
- Trial name
- NCT01310075
- Testing
- Alloderm, Surgimend
- Where
- United States
- Volunteers
- 90 people
- Sponsor
- M.D. Anderson Cancer Center
Breast Cancer
Immediate Postmastectomy Breast Reconstruction (Strattice Breast)
This prospective, multicenter, open-label study will assess the clinical outcomes of the LTM product in three planned analyses. The primary objective of this study is to prospectively assess the clinical outcomes associated with…
- Trial name
- NCT00619762
- Testing
- LTM - a porcine-based surgical mesh
- Where
- 5 sites in United States
- Volunteers
- 17 people
- Sponsor
- LifeCell
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
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
Evaluation of Half-Dose Molecular Breast Imaging With Wide Beam Reconstruction Processing
The primary objective of this work is to determine if half-dose Molecular Breast Imaging (MBI) performed with 4 mCi Tc-99m sestamibi with or without Wide Beam Reconstruction applied can achieve image quality and diagnostic…
- Trial name
- Split-Dose (NCT01653964)
- Testing
- Molecular breast imaging
- Where
- United States
- Volunteers
- 83 people, healthy volunteers welcome
- Sponsor
- Mayo Clinic