Clinical trials: Breast Reconstruction Surgery
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.
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 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.
Macromastia
Study of Prineo (Dermabond Protape) Versus Sutures in Breast Procedures
This is a prospective, controlled, randomized, multi-center clinical study of up to 80 patients with full thickness surgical incisions associated with bi-lateral breast procedures.
- Trial name
- NCT00558246
- Testing
- Dermabond Protape (Prineo), Suture
- Where
- 5 sites in Belgium, Germany and 2 more
- Volunteers
- 79 people
- Sponsor
- Ethicon, Inc.
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
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
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.
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.
Recurrent Ptosis of the Breast
Seri Surgical Scaffold Support of the Lower Pole of the Breast
Will the use of an FDA approved highly purified silk scaffold; Seri Surgical Scaffold help shape and hold the breast up on the chest preventing re-stretching and bottoming out of the breast in breast reduction or…
- Trial name
- SeriSupport (NCT02016612)
- Testing
- Seri Surgical Scaffold
- Where
- 2 sites in United States
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- Bengtson Center
Stage IA Breast Cancer, Stage IB Breast Cancer
Intraoperative Electron Beam Radiotherapy Boost in Treating Patients With Stage I-II Breast Cancer Undergoing Surgery With Reconstruction
This phase II trial studies the side effects of intraoperative electron beam radiotherapy boost and to see how well it works in treating patients with stage I-II breast cancer undergoing surgery with reconstruction.
- Conditions
- Stage IA Breast Cancer, Stage IB Breast Cancer, Stage IIA Breast Cancer, Stage IIB Breast Cancer
- Trial name
- NCT02927912
- Testing
- Electron Beam Therapy, Lumpectomy, Quality-of-Life Assessment
- Where
- 5 sites in United States, Canada
- Volunteers
- 108 people
- Sponsor
- Ohio State University Comprehensive Cancer Center
Breast Cancer
Evaluate the Use of Paravertebral Block in Reconstructive Breast Surgery
Primary Objective: To determine whether the use of a paravertebral block in patients undergoing reconstructive surgery for breast cancer results in decreased immediate post-operative pain compared with patients having only…
- Trial name
- NCT00542542
- Testing
- Paravertebral Block, Propofol, Fentanyl
- Where
- United States
- Volunteers
- 89 people
- Sponsor
- M.D. Anderson Cancer Center
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
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
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
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, Perioperative/Postoperative Complications
Fibrin Sealant in Preventing Fluid Build Up During Surgery in Patients Undergoing Breast Reconstruction
The purpose of this study is to investigate the efficacy of an alternative surgical technique and the use of fibrin sealant in preventing post-operative seroma formation.
- Trial name
- NCT01649505
- Testing
- fibrin sealant (Beriplast P, TISSEEL VH), breast reconstruction
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- OHSU Knight Cancer Institute
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