Clinical trials: Mammaplasty
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
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
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
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
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 Augmentation, Breast Reconstruction
A Pilot Study to Evaluate the BodyLogic TM System (Mentor) in Augmentation Mammaplasty
At a national level of 15%, the reoperation rate following augmentation mammaplasty is too high. We are conducting a survey to examine the pre-operative methods by which plastic surgeons determine implant volume, size, shape and…
- Trial name
- NCT00684749
- Where
- United States
- Volunteers
- 142 people
- Sponsor
- University of Minnesota
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 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, Non-Opioid Pain Management
Virtual Reality After Breast Reconstruction Surgery
This is a pilot study of virtual reality (VR) non-opioid management for women undergoing mastectomy and implant-based reconstruction.
- Conditions
- Pain, Postoperative, Non-Opioid Pain Management, Virtual Reality
- Trial name
- VR4BR (NCT03801616)
- Testing
- Virtual Reality
- Where
- United States
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Cedars-Sinai Medical Center
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
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
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, 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
Mammoplasty, Postoperative Pain
Study of EXPAREL in Patients Undergoing Breast Augmentation
This is a Phase 4, prospective, open-label, non-randomized, sequential study with two treatment groups differing only in the technique used for EXPAREL administration (instillation or infiltration).
- Trial name
- NCT01582490
- Testing
- Instillation - EXPAREL, Infiltration - EXPAREL
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- Pacira Pharmaceuticals, Inc
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
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
Perfusion; Complications
The Effect of Nitroglycerin Ointment, Fluorescent Angiography, and Incisional Negative Pressure Wound Therapy on Mastectomy Skin Flap Perfusion-Related Problems
This is a randomized study using a variety of techniques to compare and examine blood flow to the remaining skin after mastectomy. All treatments being used are considered standard of care and are not experimental.
- Trial name
- NCT03716050
- Testing
- Nitroglycerin, Negative Pressure Wound Therapy/ Wound VAC, Fluorescent Angiography with indocyanine-green (not to exceed 5mg/kg)
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- Wake Forest University Health Sciences
Breast Augmentation, Breast Reconstruction
NATRELLE® 410 X-Style and L-Style Breast Implants Continued Access Study
This study is a prospective, multicenter, nonrandomized study to provide access to and evaluate 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
- NCT01870869
- Testing
- Anatomically shaped, silicone-filled breast implants with low height/projection or extra-full projection
- Where
- 58 sites in United States
- Volunteers
- 1,951 people, healthy volunteers welcome
- Sponsor
- Allergan
Postoperative Pain
Evaluation of the Safety and Efficacy of a Single Dose of SKY0402 in Subjects Undergoing Augmentation Mammoplasty
The primary objective of this study was to demonstrate the superiority of SKY0402 over conventional, commercially-available bupivacaine HCl with respect to the duration of the analgesic effect achieved by a single local…
- Trial name
- NCT01206608
- Testing
- SKY0402 + bupivacaine HCl, Mid-dose SKY0402 + bupivacaine HCl
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Pacira Pharmaceuticals, Inc
Breast Reconstruction
The Use of Alloderm Versus Dermacell in Immediate Implant Based Breast Reconstruction
Breast reconstruction after mastectomy has been shown to provide psychosocial benefits to breast cancer patients and is considered an integral part of breast cancer treatment.
- Trial name
- REaCT-ADM (NCT03064893)
- Testing
- Alloderm, Dermacell
- Where
- Canada
- Volunteers
- 62 people
- Sponsor
- Ottawa Hospital Research Institute