Clinical trials: Mammaplasty
Breast Cancer
Surgical Site Infection With 0.05% Chlorhexidine (CHG) Compared to Triple Antibiotic Irrigation
The investigators intend to perform a prospective randomized study and compare the incidence of surgical wound infection between mastectomy wounds irrigated with triple antibiotic solution (one side) and 0.05% CHG (opposite side)…
- Trial name
- NCT02395614
- Testing
- Chlorhexidine irrigation, triple antibiotic irrigation
- Where
- United States
- Volunteers
- 88 people
- Sponsor
- Vanderbilt University Medical 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
Hyperplasia
Harmonic Scalpel Vs. Electrocautery in Breast Reduction Surgery
Purpose: The aims of this randomized clinical trial are to assess and compare 3 different outcomes in women undergoing breast reduction surgery using two different surgical devices: the Harmonic Scalpel and electrocautery.
- Trial name
- NCT00819260
- Testing
- Harmonic Scalpel, Electrocautery
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- Dartmouth-Hitchcock Medical 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
Patient and Surgical Related Risk Factors for Complications
TiLoop® Bra for Breast Reconstruction
A new approach for single stage implant based breast reconstruction (BR) is the use of a titanium-coated polypropylene mesh (TCPM) as an alternative to acellular dermal matrix (ADM).
- Trial name
- NCT01544023
- Volunteers
- 207 people
- Sponsor
- University of Rostock
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 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
Breast - Female
Transversus Abdominis Plane Block in Microsurgical Breast Recon w/Abdominal Free Flap in Breast CA
The primary objective is to determine if pre-operative transversus abdominis plane (TAP) nerve blocks by continued infusion of local anesthetic post-operatively affects post-operative narcotic usage, as compared to a placebo TAP…
- Trial name
- NCT02601027
- Testing
- Transversus Abdominis Plane (TAP) block, Nimbus Infusion Pump IV Administration, Bupivacaine infusion
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- Stanford University
Breast Cancer, Postoperative Pain
Liposomal Bupivacaine in Implant Based Breast Reconstruction
Objectives: 1. To evaluate the effect of liposomal bupivacaine on postoperative pain levels. 2. To evaluate the effect of liposomal bupivacaine on postoperative opioid consumption and opioid related adverse events. 3.
- Trial name
- NCT02659501
- Testing
- Liposomal bupivacaine, Bupivacaine with epinephrine, Morphine sulfate
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Loma Linda University
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.
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
Feasibility Study of Meso BioMatrix Device for Breast Reconstruction
The purpose of the study is to evaluate the safety and feasibility of the use of Meso BioMatrix Acellular Peritoneum Matrix for the reinforcement of weakened soft tissue during 2-stage, tissue expander assisted breast…
- Trial name
- NCT01823107
- Testing
- Meso BioMatrix Device
- Where
- 6 sites in United States
- Volunteers
- 25 people
- Sponsor
- Kensey Nash Corporation
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 Reconstruction, Breast Cancer
Implementing BREASTChoice Into Practice
Breast reconstruction after mastectomy is a highly personal decision. Although it can restore quality of life for many, there are numerous risks associated with the procedure.
- Trial name
- NCT04491591
- Testing
- Breast Reconstruction Education and Support Tool (BREASTChoice), Attention Control Website, Clinician Survey
- Where
- 2 sites in United States
- Volunteers
- 396 people
- Sponsor
- Washington University School of Medicine
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
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
Scar, Surgical Scar
Pilot Study of a Novel 532nm KTP Laser for the Treatment of Fresh Surgical Scars
The purpose of this study is to evaluate the safety and efficacy of the 532nm potassium titanyl phosphate (KTP) laser in comparison with the 595nm pulsed-dye laser (PDL) for the treatment of fresh surgical scars.
- Conditions
- Scar, Surgical Scar, Cicatrix, Cicatrix, Hypertrophic
- Trial name
- NCT01789346
- Testing
- 532nm KTP, 595nm PDL
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Cutera Inc.
Other Reconstructive Surgery, Failure of Muscle Graft
Robotic Harvest of the Latissimus Dorsi (LD) Muscles
The goal of this clinical research study is to learn more about the safety and feasibility of using the Da Vinci Robotic Surgical system in procedures that harvest the latissimus dorsi muscle (a back muscle below your shoulder)…
- Conditions
- Other Reconstructive Surgery, Failure of Muscle Graft, Cancer, Complications
- Trial name
- NCT02274493
- Testing
- da Vinci® Robotic Surgical System, LD muscle flap harvest procedure, Reconstructive surgery
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- M.D. Anderson Cancer Center
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