Clinical trials: Breast Implants
Breast Reconstruction, Patient Education
Educational Session To Optimize Patient's Breast Reconstruction Experience at McMaster
This pilot study uses a randomized controlled trial design to introduce an educational session for breast reconstruction patients. Participants will be randomly assigned to the (1) control group or the (2) experimental group.
- Trial name
- RESTORE (NCT03743753)
- Testing
- Experimental
- Where
- 2 sites in Canada
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- McMaster University
Breast Cancer
SPY Intra-Operative Angiography & Skin Perfusion in Immediate Breast Reconstruction w/ Implants
The investigators hope to learn the value of the SPY ELITE® intra-operative angiography in reducing post-operative complications associated with low breast skin blood flow after breast reconstruction using implants.
- Trial name
- NCT01315119
- Testing
- SPY Intra-Operative Angiography
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Stanford University
Breast Reconstruction
Do Closed Suction Drains Affect the Complications Rate of Breast Reconstruction With Silicone Prosthesis?
The purpose of this study is to describe the relations between closed suction drains placement in breast reconstructions procedures with silicone prothesis to the development of local wound complications (seroma, hematoma…
- Trial name
- NCT00973544
- Testing
- Cultures taken from the drain discharge
- Volunteers
- 100 people
- Sponsor
- Sheba Medical Center
Postoperative Pain, Postoperative Nausea and Vomiting
Pre-pectoral AlloDerm® to Reinforce Tissues in Tissue Expander Breast Reconstruction
Primary Objective: To describe postoperative static pain scores on the Pain Visual Analog Scale at Day 1 in a population of women undergoing bilateral mastectomy followed by immediate, bilateral pre-pectoral tissue expander…
- Conditions
- Postoperative Pain, Postoperative Nausea and Vomiting, Quality of Life, Breast Cancer
- Trial name
- NCT03195322
- Testing
- Pre-pectoral Tissue Expander
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Johns Hopkins University
Postoperative Seroma Rate, Drainage Tube Removal Time, and Capsular Contracture Rate, Seroma Following Procedure
Pseudomonas Aeruginosa Injection Combined With Polyvinylpyrrolidone-Iodine in Immediate Breast Reconstruction Surgery With Implants
Brief Summary This study hypothesizes that in immediate breast reconstruction following tumor resection, the application of inactivated Pseudomonas aeruginosa preparation (PAP) may reduce infection rates by decreasing…
- Trial name
- RCT of PAI + P (NCT07460297)
- Testing
- Pseudomonas aeruginosa, Povidone-Iodine
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Jianyi Li
Breast Reconstruction, Implant-Based Breast Reconstruction (IBBR)
Pre- Versus Sub-pectoral Implant-based Breast Reconstruction After Skin-sparing Mastectomy or Nipple-sparing Mastectomy OPBC-02PREPEC
This trial is to investigate whether pre-pectoral Implant-Based Breast Reconstruction (IBBR) provides better Quality of Life (QoL) with respect to long-term (24 months) physical well-being (chest) compared to sub-pectoral IBBR…
- Trial name
- OPBC-02PREPEC (NCT04293146)
- Testing
- pre-pectoral IBBR, sub-pectoral IBBR
- Where
- 22 sites in United States, Austria and 5 more
- Volunteers
- 382 people
- Sponsor
- University Hospital, Basel, Switzerland
Breast Augmentation, Mammaplasty
The Study is an Observational Post-market Follow-up Program to Evaluate Long Term (5 Years) Safety of Mentor Breast Implants in Chinese Population
The Mentor Post-Market Clinical Follow-Up Study is a multicenter observational study conducted in China. It aims to collect safety data on Mentor breast implants over a 5-year follow-up period in the Chinese population.
- Trial name
- NCT06510205
- Testing
- Mentor Breast implants
- Where
- 4 sites in China
- Volunteers
- 6,111 people
- Sponsor
- Johnson & Johnson Medical (Shanghai) Ltd.
Mammary Cancer, Erector Spinae Plane Block
Effect of ESPB on Postoperative Pain in Patients With Breast Cancer Implant Reconstruction
Nowadays, the incidence of breast cancer is the first number of malignant tumors, and the primary treatment method is surgery.With the development of medical technology and concept, radical mastectomy combined breast…
- Conditions
- Mammary Cancer, Erector Spinae Plane Block, Postoperative Pain
- Trial name
- NCT06143020
- Testing
- Erector spinae plane block
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Fudan University
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
Breast Reconstruction, Flap Necrosis
a Prospective Study of Surgical Results, Complications and Predictive Values in Chinese Women Breast Reconstruction
This study prospectively evaluates and compares the effectiveness of ICG fluorescence imaging and LSCI in predicting the risk of necrosis following direct-to-implant breast reconstruction.
- Trial name
- BEST (NCT06779019)
- Testing
- LSCI, ICG (Indocyanine Green)
- Where
- China
- Volunteers
- 40 people
- Sponsor
- Peking Union Medical College Hospital
Breast Reconstruction Following Mastectomy
Does Nerve Grafting Improve Sensation After Nipple-Sparing Mastectomy With Implant Reconstruction?
The goal of this clinical trial is to learn if adding an allogeneic (donor) nerve graft during breast reconstruction can improve recovery of breast and nipple sensation in women undergoing bilateral nipple-sparing mastectomy with…
- Trial name
- NCT07819357
- Testing
- Allogeneic Nerve Grafting
- Where
- 3 sites in United States
- Volunteers
- 45 people
- Sponsor
- Endeavor Health
Breast Cancer
Iterative PICC Placement Versus Long Term Device
Peripherally Inserted Central Catheter (PICC) and port-a-cath (PAC) are the most commonly medical devices used for the administration of chemotherapy.
- Trial name
- PICC One Day (NCT02784730)
- Testing
- Iterative PICC placement, Long term PAC placement
- Where
- France
- Sponsor
- Centre Leon Berard
Reconstructive Surgical Procedures
The SurgiMend PRS Retrospective Study
The SurgiMend® PRS Retrospective Study will evaluate the performance and safety of SurgiMend® PRS and SurgiMend® PRS Meshed when used for soft tissue reinforcement under the product's indications for use.
- Trial name
- NCT05182177
- Testing
- SurgiMend PRS
- Where
- 6 sites in Italy, Switzerland and 1 more
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Integra LifeSciences Corporation
Breast Cancer
Cost-Effectiveness of Abdominal-based Autogenous Tissue vs Tissue Expander-Implant Reconstruction - A Feasibility Study
It is estimated that about 25% and 40% of health care expenditures in Canada and USA respectively are wasted because of inefficiencies and not practicing evidence-based medicine.
- Trial name
- NCT02438449
- Testing
- Breast Reconstruction Surgery
- Where
- Canada
- Volunteers
- 61 people, healthy volunteers welcome
- Sponsor
- McMaster University
Breast Cancer, Breast Implant; Complications
Association of Silicone Breast Implants With Overall Wellbeingand Auto-immune Diseases
Background: Implant-based breast reconstructions contribute considerably to the quality of life of breast cancer patients. A knowledge gap exists concerning the potential role of breast implants in the development of so called…
- Conditions
- Breast Cancer, Breast Implant; Complications, Autoimmune Diseases
- Trial name
- AREOLA-B (NCT05400954)
- Testing
- Breast reconstruction with silicone breast implant, Breast conserving surgery/Mastectomy/Autologous reconstruction, Breast Augmentation
- Where
- 7 sites in Netherlands
- Volunteers
- 15,000 people
- Sponsor
- The Netherlands Cancer Institute
Breast Neoplasms
Clinical Outcomes and Complications in Two-stage Breast Reconstruction Using Microtextured and Nanotextured Expanders
This retrospective observational study evaluates clinical outcomes and complication rates in women who underwent two-staged implant-based breast reconstruction using tissue expanders and implants following mastectomy for breast…
- Trial name
- RA-IBBR-NvsM (NCT07442838)
- Where
- Slovakia
- Volunteers
- 88 people
- Sponsor
- Comenius 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
Breast Cancer, Breast Reconstruction
Implant-based Breast Reconstruction in Post-bariatric Women - a Registry-based National Study
The goal of this national registry-based study is to investigate the prevalence of reconstructive breast surgery and risk factors for surgical complications in women who have had weight loss surgery previously.
- Conditions
- Breast Cancer, Breast Reconstruction, Bariatric Surgery, Breast Implant
- Trial name
- NCT07059104
- Testing
- Breast augmentation, Breast reconstruction after mastectomy
- Where
- Sweden
- Volunteers
- 20,000 people
- Sponsor
- Vastra Gotaland Region
Breast Implant Rupture
Prevalence of Asymptomatic Rupture in SILIMED Breast Implants
A prospective clinical research is to assess the prevalence of implant rupture and presence of extracapsular gel in an un-referred population of women who have been implanted with the Silimed gel-filled mammary implants with or…
- Trial name
- NCT02206282
- Volunteers
- 390 people
- Sponsor
- Silimed Industria de Implantes Ltda
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