Clinical trials: Breast Reconstruction
Breast Cancer Female
PEMF and PEC Blocks in Mastectomy Reconstruction Patients
This is a prospective randomized controlled double-blind interventional study comparing the effect of pulsed-electromagnetic field device (PEMF), pectoral interfascial block (PIB), and placebo on postoperative pain control.
- Trial name
- NCT03360214
- Testing
- Bupivacaine Hydrochloride, Pulsed Electromagnetic Field (PEMF) Device, Ropivacaine Hydrochloride
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Columbia University
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 Augmentation, Breast Reconstruction
NATRELLE® 410 Full and Moderate Height/Projection Breast Implant Continued Access Post-Approval Study
Post-approval study of the safety and effectiveness of NATRELLE® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants (Styles 410 FM, FF, MM, or MF) for breast augmentation, reconstruction, or revision
- Conditions
- Breast Augmentation, Breast Reconstruction, Breast Implant Revision
- Trial name
- NCT01853605
- Testing
- Anatomically shaped silicone gel-filled breast implants
- Where
- United States
- Volunteers
- 3,811 people, healthy volunteers welcome
- Sponsor
- Allergan
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
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
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
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-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
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, Breast Reconstruction
Evaluation of the Cook Biodesign® Nipple Reconstruction Cylinder (NRC)
Patients with a desire for nipple reconstruction following breast cancer and breast reconstruction will receive a surgical procedure to reconstruct one or both nipples utilizing the COOK Biodesign® Nipple Reconstruction Cylinder.
- Conditions
- Breast Cancer, Breast Reconstruction, Nipple Reconstruction
- Trial name
- NRC (NCT01216319)
- Testing
- Nipple reconstruction
- Where
- 4 sites in United States
- Volunteers
- 50 people
- Sponsor
- Cook Group Incorporated
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.
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.
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.
Pain, Postoperative, Mammaplasty
Combination Dexamethasone and Bupivacaine Pain Control in Reduction Mammaplasty
The addition of dexamethasone to non-liposomal bupivacaine in perineural blocks has been shown to enhance pain control and prolong the time until first request for postoperative narcotics in the fields of orthopedic, thoracic…
- Trial name
- NCT04919317
- Testing
- Dexamethasone 4mg, Saline
- Where
- United States
- Volunteers
- 56 people
- Sponsor
- Temple University
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 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 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
Breast Reconstruction, Contour Irregularities
Immunophenotyping of Fresh Stromal Vascular Fraction From Adipose Derived Stem Cells (ADSC) Enriched Fat Grafts
The purpose of this study is to investigate if there is a relationship between the take of fat grafts with and without ADSCs and the presence of specific surface markers on the cells of the stromal vascular fraction.
- Conditions
- Breast Reconstruction, Contour Irregularities, Volume Insufficiency
- Trial name
- NCT01771913
- Testing
- centrifuged fat graft, ADSCs enriched fat graft
- Where
- Brazil
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- University of Sao Paulo
Breast Cancer
Study of Radiation Fractionation on Patient Outcomes After Breast REConstruction (FABREC) for Invasive Breast Carcinoma
This study is a randomized trial of hypofractionation (short-course) radiation therapy versus conventional radiation therapy in women who have undergone mastectomy and immediate breast reconstruction.
- Trial name
- NCT03422003
- Testing
- Radiation Therapy
- Where
- 15 sites in United States
- Volunteers
- 400 people
- Sponsor
- Dana-Farber Cancer Institute
Breast Augmentation, Breast Reconstruction
Safety and Effectiveness of Style 410 Silicone-Filled Breast Implant Study
Safety and effectiveness of Style 410 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
- NCT00690339
- Testing
- Style 410 Silicone-Filled Breast Implants
- Where
- United States
- Volunteers
- 941 people, healthy volunteers welcome
- Sponsor
- Allergan Medical