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
Use of Mobile App Home Monitoring After Ambulatory Surgery
The Effect of Mobile App Home Monitoring on the Number of In-Person Visits Following Ambulatory Surgery
This study evaluate if in an ambulatory breast reconstruction patient population at Women's College Hospital (WCH), can we avert in-person follow-up care through the use of mobile app home monitoring compared to conventional…
- Trial name
- NCT02318953
- Testing
- Mobile app follow-up care, Conventional, in-person follow-up care
- Where
- Canada
- Volunteers
- 70 people
- Sponsor
- Women's College Hospital
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.
Blood Transfusion, Blood Transfusion, Autologous
A Study to Determine the Effectiveness of Epoetin Alfa in Facilitating Self-donation of Blood Before Surgery in Non-anemic Patients Who Are Undergoing Orthopedic, Heart and Blood Vessel, or Breast Reduction Surgery; Performed in Combination With a Procedure to Reduce Blood Loss During Surgery.
The purpose of this study is to determine the safety and effectiveness of epoetin alfa and whether epoetin alfa will enable self-donation of blood during an 11-day period before surgery (which is shorter than the conventional…
- Conditions
- Blood Transfusion, Blood Transfusion, Autologous, Orthopedic Procedures, Orthopedic Surgery
- Trial name
- NCT00270023
- Testing
- epoetin alfa
- Volunteers
- 112 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Reconstructive Surgical Procedures
A Retrospective Assessment of OviTex PRS (OviTex)
The objective of this retrospective-prospective, observational study is to evaluate the safety profile overall and within two device types of OviTex PRS in previous pre-pectoral or sub-pectoral implant-based breast…
- Trial name
- PRS (NCT05736848)
- Testing
- OviTex® PRS
- Where
- 11 sites in United States
- Volunteers
- 200 people
- Sponsor
- Tela Bio Inc
Surgical Side Infections After Breast Reduction
Increased Microcirculation for Preventing Postoperative Wound Infections in Patients Undergoing Reduction Mammoplasty
In this prospective study we investigated the impact of an improved postoperative microcirculation and its effect of surgical side infections after breast reduction.
- Trial name
- NCT01538173
- Testing
- 250ml HES 6%, 9% NaCl 500ml
- Where
- Germany
- Volunteers
- 334 people
- Sponsor
- Max Dieterich
Breast Implant; Complications, Breast Implant Protrusion
Standard Silicone-based vs. B-Lite® Light Weight Breast Implant After Total Mastectomy and Radiotherapy for Breast Cancer
Reconstructive surgery with breast implants after total mastectomy for breast cancer is invariably related to several possible complications, such as atrophy of surrounding tissues, skin thinning, capsular contracture, wound…
- Conditions
- Breast Implant; Complications, Breast Implant Protrusion, Breast Cancer, Radiotherapy Side Effect
- Trial name
- BLITE-01 (NCT03737500)
- Testing
- B-Lite® light weight breast implant, Standard silicone-based breast implant
- Where
- Italy
- Volunteers
- 49 people
- Sponsor
- Istituti Clinici Scientifici Maugeri SpA
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 Neoplasm
Comparison of FlexHD and Alloderm Outcomes in Breast Reconstructive Surgery
FlexHD and Alloderm are two common products used in breast reconstruction to hold tissue expanders and implants in place. There have been few chart review studies comparing outcomes between the two materials in breast…
- Trial name
- NCT02372305
- Testing
- FlexHD, Alloderm
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- University of Arkansas
Mammoplasty, Scarring
A Study of Granexin® Gel for the Reduction of Scar Formation in Surgical Wounds Following Bilateral Anchor Incision Breast Surgery
The purpose of this study is to evaluate effectiveness of Granexin® gel in reducing scar formation in surgical incisional wounds.
- Conditions
- Mammoplasty, Scarring, Scar, Breast Reconstruction
- Trial name
- NCT04331080
- Testing
- Granexin® gel 100 μM, Granexin® gel 200 μM, Vehicle gel
- Where
- 11 sites in United States
- Volunteers
- 184 people, healthy volunteers welcome
- Sponsor
- Xequel Bio, Inc.
Implant Based Breast Reconstruction
Post-market Surveillance Study to Evaluate the Quality of Life and the Safety and Effectiveness of the TIGR® Matrix After Reconstructive Breast Surgery
The goal of this observational study is to evaluate the quality of life of participants who have undergone implant-based breast surgery. This will be done using the BREAST-Q questionnaire.
- Trial name
- TIGR-Matrix (NCT06511167)
- Testing
- TIGR® Matrix
- Where
- 5 sites in Germany
- Volunteers
- 135 people
- Sponsor
- AWOgyn
Breast Cancer, Mastectomy
Same-Day Awake Mastectomy With Immediate Breast Reconstruction for Patients With Breast Cancer
The goal of this clinical trial is to learn if the AMADeuS care pathway is as safe as usual hospital care and works as well for pain control in women having mastectomy with immediate prepectoral breast reconstruction.
- Conditions
- Breast Cancer, Mastectomy, Prepectoral Breast Reconstruction, ERAS Programmes
- Trial name
- AMADeuS (NCT07510698)
- Testing
- AMADeuS Perioperative Pathway, Usual Perioperative Care
- Where
- Italy
- Volunteers
- 100 people
- Sponsor
- University of Rome Tor Vergata
Breast Surgery, Macromastia
Comparison of ESP and SPSIP Blocks in Breast Surgery
This study aims to compare the efficacy of the ESP and SPSIP blocks in managing postoperative pain following breast surgery. Breast surgery, particularly after oncological and reconstructive procedures, often leads to significant…
- Conditions
- Breast Surgery, Macromastia, Mammaplasty, Modified Radical Mastectomy
- Trial name
- NCT06611644
- Testing
- Erector Spinae Plane Block, SPSIPB blcok, Control
- Where
- Turkey (Türkiye)
- Volunteers
- 75 people
- Sponsor
- Çanakkale Onsekiz Mart University
Breast Carcinoma
An Investigational Surgical Procedure (Vascularized Lymph Node Transfer) in Reducing the Risk of Lymphedema in Patients With Breast Cancer Undergoing Breast Reconstruction
This trial studies how an investigational surgical procedure called vascularized lymph node transfer works in lowering the risk of arm swelling (lymphedema) in patients with breast cancer undergoing breast reconstruction.
- Trial name
- NCT03990610
- Testing
- Mammoplasty, Vascularized Lymph Node Transfer
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- M.D. Anderson Cancer Center
Breast Cancer Patients
Efficacy and Safety of Prepectoral Prosthesis Immediate One-Stage Breast Reconstruction Versus Two-Stage Expander/Prosthesis Reconstruction in Postoperative Adjuvant Radiotherapy Breast Cancer Patients: A Prospective, Single-Center, Cohort Study
Prospective Evaluation of the Efficacy and Safety of Prepectoral Immediate One-Stage Prosthetic Breast Reconstruction Versus Two-Stage Expander/Prosthesis Reconstruction in Postoperative Adjuvant Radiotherapy Breast Cancer…
- Trial name
- NCT07037576
- Testing
- Breast Reconstruction Surgery
- Where
- China
- Volunteers
- 104 people
- Sponsor
- Henan Cancer Hospital
Breast Cancer
Hypofractionated Radiotherapy After Breast Reconstruction for Breast Cancer
This study aims to evaluate the efficacy and safety of hyperfractionated radiotherapy (40Gy/15 fractions) compared to conventional fractionated radiotherapy (50Gy/25 fractions) in breast cancer patients undergoing breast…
- Trial name
- NCT07831889
- Testing
- Whole-dose radiotherapy, Conventional fractionated radiotherapy
- Volunteers
- 960 people
- Sponsor
- Tianjin Medical University Cancer Institute and Hospital
Mastectomy, Mammaplasty
A Comparative Analysis of REVOLVE, LipoGrafter, and Viality in Autologous Fat Grafting During Breast Surgery
The purpose of this study is to learn whether there is a superior fat processing method in terms of graft retention in breast reconstruction after mastectomy.
- Conditions
- Mastectomy, Mammaplasty, Breast Reconstruction
- Trial name
- NCT04891510
- Testing
- REVOLVE Advanced Adipose System, LipoGrafter, Viality
- Where
- United States
- Volunteers
- 135 people
- Sponsor
- Weill Medical College of Cornell University
Breast Cancer
Evaluation of the Safety and Efficacy of Single-Port Robot-Assisted Endoscopic Breast-Conserving Surgery and Nipple-sparing Matectomy With Reconstruction in Early-Stage Breast Cancer Patients
This study is testing a new, less invasive way to perform breast cancer surgery using a single-port robotic system (a robot-assisted surgical tool made in China, called the Shurui SR-ENS-600).
- Trial name
- NCT07781163
- Testing
- single-port robot-assisted surgery
- Volunteers
- 30 people
- Sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Surgical Site Infection
Dressing Wear Time After Breast Augmentation With Prosthesis
This study was designed to determine whether the duration of dressing wear following augmentation mammaplasty influence skin colonization and eventually surgical site infections rates.
- Trial name
- NCT01553604
- Testing
- augmentation mammaplasty
- Where
- Brazil
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Daniela Francescato Veiga
Drain Output After Breast Reduction Surgery, Breast Reductions
Effect of Intravenous and Topical Tranexamic Acid on Drain Output in Breast Reduction Surgery
This study aims to evaluate whether tranexamic acid (TXA), a medication that helps reduce bleeding, can decrease fluid drainage after breast reduction surgery.
- Trial name
- NCT07131592
- Testing
- IV TXA, Topical TXA, Topical saline
- Where
- United States
- Volunteers
- 160 people
- Sponsor
- Massachusetts General Hospital