Clinical trials: Breast Reconstruction
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 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
Breast Ptosis, Obesity
Evaluation of Dermal Closure With an Absorbable Barbed Suture as Compared to a Conventional Absorbable Suture
The objective of this study is to evaluate the use of an absorbable barbed suture as compared to a conventional absorbable suture when used for dermal closure during certain body contouring procedures.
- Trial name
- NCT00959374
- Testing
- V-Loc 180/90 Wound Closure Device, 3-0 Monocryl Absorbable Sutures
- Where
- 8 sites in United States, Germany
- Volunteers
- 229 people, healthy volunteers welcome
- Sponsor
- Medtronic - MITG
Breast-Conserving Surgery
Regenerative Collagen Scaffold for Breast Volume Restoration After Breast Cancer Excision
This clinical trial evaluates the safety and efficacy of High Purity Type I Collagen scaffold for breast volume restoration following breast-conserving surgery (BCS).
- Trial name
- NCT07219316
- Testing
- High Purity Type I Collagen Scaffold (Regenerative Matrix)
- Where
- 2 sites in India
- Volunteers
- 40 people
- Sponsor
- Adichunchanagiri Institute of Medical Sciences, B G Nagara
Postoperative Pain
Phase 2B Upper Extremity Nerve Block Study
This is a Phase 2B, randomized, assessor-blind, active- and saline placebo-controlled, multicenter study in subjects undergoing augmentation mammoplasty to evaluate the analgesic efficacy, safety, and pharmacokinetics (PK) of…
- Trial name
- NCT03011333
- Testing
- HTX-011, Bupivacaine HCl without epinephrine
- Where
- 2 sites in United States
- Volunteers
- 243 people
- Sponsor
- Heron Therapeutics
Delayed Healing
PICO Breast Reduction Clinical Study Looking at Incision Healing Complications
The purpose of this study is to see if the use of a single-use negative pressure wound therapy system (NPWT) will have an effect on the reduction of post-surgical incision healing complications following breast reduction surgery…
- Trial name
- NCT01640366
- Testing
- PICO
- Where
- 6 sites in United States, France and 2 more
- Volunteers
- 200 people
- Sponsor
- Smith & Nephew, Inc.
Breast Hypertrophy, Abdominal Elastosis
Randomized Controlled Trial of Subcuticular Skin Closure Versus Steri-strip S Closure
Purpose: The aims of this randomized clinical trial are: 1. to assess scar quality from the patient and surgeon perspectives 2. to assess patient comfort in the days immediately following surgery 3.
- Conditions
- Breast Hypertrophy, Abdominal Elastosis, Breast Reconstruction
- Trial name
- NCT00727025
- Testing
- wound closure device (Steri-Strip™)
- Where
- United States
- Volunteers
- 51 people
- Sponsor
- Dartmouth-Hitchcock Medical Center
Pain, Postoperative, Mammaplasty
Efficacy of Liposomal Bupivacaine for Prolonged Postoperative Analgesia in Patient Undergoing Breast Reconstruction With Tissue Expander
Patients undergoing breast reconstruction with tissue expanders will be treated with a local anesthetic during their procedure and monitor their post-operative pain level and amount of oral pain medication taken.
- Trial name
- NCT04278846
- Testing
- Depofoam bupivacaine, Bupivacaine hydrochloride (HCl)
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- The Cleveland Clinic
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 Cancer
Decellularized, Whole Donor Nipple-Areola Complex Reconstruction Grafts
The goal of this study is to evaluate safety and healing time after nipple-areolar complex (NAC) reconstruction with the BioAesthetics' decellularized human nipple-areolar complex (dcl-hNAC) graft in patients who have had…
- Trial name
- NCT04534010
- Testing
- NACgraft
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Stanford University
Breast Augmentation, Breast Reconstruction
Safety and Effectiveness of Natrelle(TM) Cohesive Round Silicone-Filled Breast Implants
Safety and effectiveness of Natrelle™ Cohesive Round 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
- NCT00689871
- Testing
- Natrelle(TM) Silicone-Filled Breast Implants
- Where
- United States
- Volunteers
- 715 people, healthy volunteers welcome
- Sponsor
- Allergan Medical
Surgical Wound, Breast Surgery
Continuous Diffusion of Oxygen Treatment for Incision Wounds
This is an exploratory randomized controlled trial study to test feasibility, acceptability, and proof of concept efficacy of Continuous Diffusion of Oxygen (CDO) adjunct therapy for decreasing healing time and reducing tissue…
- Conditions
- Surgical Wound, Breast Surgery, Mammoplasty, Incision Wound
- Trial name
- NCT04307355
- Testing
- Transcu O2®, Tegaderm, Silagen
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- Baylor College of Medicine
Hematoma Postoperative, Venous Thromboembolism
Use of Tranexamic Acid in Reduction Mammoplasty
Breast reduction mammoplasty (BRM) is among the most commonly performed procedures in plastic surgery. However, postoperative hematoma is one of the most common complications following BRM.
- Trial name
- TREX-ARM (NCT04947514)
- Testing
- Tranexamic acid
- Where
- United States
- Volunteers
- 98 people, healthy volunteers welcome
- Sponsor
- Montefiore Medical Center
Mammaplasty
Analgesic Efficacy of Liposomal Bupivacaine vs. Bupivacaine HCL as a Tap Block After Abdominally Based Autologous Breast Reconstruction
This study will evaluate the efficacy of analgesia provided by liposomal bupivacaine (Exparel) when compared to bupivacaine HCL as a transverse abdominis plane (TAP) block in terms of discharge milestones, opioid use, costs, and…
- Trial name
- NCT02662036
- Testing
- Bupivicaine HCL, Liposomal bupivacaine
- Where
- United States
- Volunteers
- 70 people
- Sponsor
- Washington University School of Medicine
Breast Cancer
Decision Support Workshop for Breast Reconstruction
The purpose of this study is to determine the effectiveness of a pre-consultation decision support workshop for breast reconstruction after breast cancer, in facilitating the decision-making process, compared to routine…
- Trial name
- DSW (NCT01857882)
- Testing
- Decision Support Workshop
- Where
- Canada
- Volunteers
- 41 people
- Sponsor
- University Health Network, Toronto
Breast Augmentation, Breast Reconstruction
CPG Styles Study: A Study of the Safety of the Contour Profile Gel Breast Implants (CPG Styles Study)
The CPG Styles Study is designed to demonstrate the safety of different styles of Mentor's Contour Profile Gel (CPG) breast implants in women who are undergoing primary augmentation, primary reconstruction, or revision.
- Conditions
- Breast Augmentation, Breast Reconstruction, Breast Revision
- Trial name
- NCT01959880
- Testing
- The Contour Profile Gel (CPG) breast implants
- Where
- United States
- Volunteers
- 1,891 people, healthy volunteers welcome
- Sponsor
- Mentor Worldwide, LLC
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
Adjunct Study of Natrelle(TM) Cohesive Round Silicone-Filled Breast Implants
Safety and effectiveness of Natrelle™ Cohesive Round Silicone-Filled Breast Implants in women undergoing primary reconstruction or revision of existing breast implants.
- Trial name
- NCT00691327
- Testing
- Natrelle(TM) Silicone-Filled Breast Implants
- Where
- United States
- Volunteers
- 84,329 people, healthy volunteers welcome
- Sponsor
- Allergan Medical
Postoperative Pain
Bupivacaine HCl PK and Safety in Augmentation Mammoplasty
This is a Phase 4, randomized, open-label study of bupivacaine HCl administered either by instillation into the surgical site or by injection into the surgical site in subjects undergoing bilateral submuscular augmentation…
- Trial name
- NCT03705065
- Testing
- Bupivacaine HCl
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Heron Therapeutics
Transversus Abdominis Plane (TAP) Block Catheter, DIEP or Free MS-TRAM Breast Reconstruction
TAP Block in DIEP or Free MS-TRAM Donor Site: A RCT
Breast reconstruction using a patient's own abdominal tissue is one of the most common methods for restoring mastectomy defects for breast cancer patients.
- Conditions
- Transversus Abdominis Plane (TAP) Block Catheter, DIEP or Free MS-TRAM Breast Reconstruction, Local Pain Management, Abdominal/ Donor Site
- Trial name
- NCT01398982
- Testing
- Bupivacaine (study group), Isotonic saline (control group)
- Where
- Canada
- Volunteers
- 93 people
- Sponsor
- University Health Network, Toronto