Clinical trials: Reconstructive Breast Surgery
Breast Cancer
Breast Reconstruction and Body Map : Assessment by Functional MRI (REMASCO)
Breast reconstruction is an integral part of the management of patients with breast cancer and treated by total mastectomy. The aim of breast reconstruction is to get a satisfying aesthetic and functional result (sensitivity) and…
- Trial name
- REMASCO (NCT02553967)
- Testing
- Functional MRI
- Where
- France
- Volunteers
- 49 people
- Sponsor
- Centre Oscar Lambret
Implant Complication, Implant Infection
Local Antibiotics for Breast Implants
The BREAST-AB Trial is a multi-center, randomized, double blind, placebo-controlled trial investigating the efficacy of local application of gentamicin, vancomycin and cefazolin in decreasing all-cause implant explantation after…
- Conditions
- Implant Complication, Implant Infection, Implant Site Infection, Implant Capsular Contracture
- Trial name
- BREAST-AB (NCT04731025)
- Testing
- Gentamicin, Cefazolin and Vancomycin
- Where
- 8 sites in Denmark
- Volunteers
- 1,003 people, healthy volunteers welcome
- Sponsor
- Mikkel Herly
Breast Reconstruction, Abdominal Wall Morbidity
Changes To The Abdominal Wall After DIEP Flap Breast Reconstruction
The purpose of this study was to perform an evaluation of the structural changes in the abdominal wall after harvesting a DIEP flap in breast reconstruction.
- Trial name
- NCT02563977
- Testing
- 2 year postop CT scan of the abdomen
- Where
- Norway
- Volunteers
- 14 people
- Sponsor
- Oslo University Hospital
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
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
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
no Reconstructive Breast Surgery
Intercostal Nerves Block in the Midaxillary Line Versus Paravertebral Block for no Reconstructive Breast Surgery
The main objectives of the trial are the efficacy and safety of intercostal nerve block in the midaxillary line versus paravertebral block, both guided by ultrasound in patients scheduled for not reconstructive breast surgery.
- Trial name
- NCT02018601
- Testing
- BRILMA, paravertebral block, dexketoprofen
- Where
- Spain
- Volunteers
- 120 people
- Sponsor
- Paula Diéguez García
Breast, Radiotherapy
Prospective Outcomes After Reconstruction and Radiotherapy for Breast Cancer
This study examines the aesthetic outcomes of breast reconstruction after mastectomy for breast cancer in patients who require post-mastectomy radiation treatment.
- Conditions
- Breast, Radiotherapy, Aesthetics, Treatment Outcome
- Trial name
- NCT00845078
- Sponsor
- University of Pittsburgh
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
Quality of Life, Mastectomy
Registry of Mastectomy for Breast Cancer Risk Reduction
This is a registry for patients who have a risk-reduction mastectomy ("prophylactic mastectomy") due to being at high risk for developing breast cancer, followed by breast reconstruction.
- Conditions
- Quality of Life, Mastectomy, Breast Neoplasms, Genetic Predisposition to Disease
- Trial name
- NCT00555503
- Where
- United States
- Volunteers
- 261 people
- Sponsor
- Georgetown University
Breast Cancer, Breast Hypertrophy
Validation of Scales in Reconstructive Breast Surgery
The main purpose of the project is to validate patient reported outcomes measures (PROMs) in reconstructive breast surgery. BREAST-Q will be evaluated for Swedish and Sweden.Hospital Anxiety and Depression Scale (HADS), EuroQol…
- Trial name
- ValPlast (NCT05233891)
- Testing
- Breast reconstruction, Breast reduction
- Where
- Sweden
- Volunteers
- 500 people
- Sponsor
- Vastra Gotaland Region
Hypomastia, Primary Breast Augmentation
3D Breast Imaging for Cosmetic and Reconstructive Breast Surgery
The purpose of this trial is to evaluate the impact of incorporating three-dimensional (3D)imaging during preoperative consultation on patient reported outcomes in primary breast augmentation surgery.
- Trial name
- NCT01964105
- Testing
- 3D Imaging
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Washington University School of Medicine
Ischemia
Skin Flap Visible Light Spectroscopy (VLS) Oximetry for Monitoring Free-Flap Ischemia During Breast Reconstruction and Recovery
The purpose of the study is to understand the relevance of tissue oximetry measures of tissue flaps during surgery and during recovery, and to determine if T-Stat is a reliable and early method of detecting compromised flaps.
- Trial name
- NCT01173133
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Spectros Corporation
Cancer
Objective Flap Assessment During Reconstructive Surgery
The main purpose of this study is to test the ergonomics of an investigational imaging system that can take pictures of blood vessels under the skin.
- Trial name
- NCT00952107
- Testing
- FLARE imaging system
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Beth Israel Deaconess Medical Center
Breast Neoplasms, Skin Abnormalities
Pilot Study of Skin Quality Improvement After Adipose-drived Stem Cell Transfer in Irradiated Breasts
The aim of this study is to evaluate the skin quality of using adipose-drived stromal vascular fraction (SVF) cell taken by automatic centrifuge for adipose-drived cell isolation system into irradiated breasts.
- Trial name
- NCT01801878
- Testing
- Adipose SVF cell, Normal saline
- Where
- South Korea
- Sponsor
- Seoul National University Hospital
Breast Cancer
Wearable Device Tracked Recovery From Autologous Breast Reconstructive Surgery
The purpose of this research study is to learn more about how patients recover after DIEP flap breast reconstruction. We will use a wrist worn activity tracker (Fitbit Inspire 3) to measure steps, heart rate, and sleep before and…
- Trial name
- NCT07631026
- Testing
- Questionnaires
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- M.D. Anderson Cancer Center
Breast Cancer, Reconstructive Surgery
The BREASTrial:Breast Reconstruction Evaluation Using Acellular Dermal Matrix as a Sling Trial
Primary Hypothesis: 1. Alloderm and Dermamatrix have comparable complication rates when used for staged breast reconstruction Secondary hypotheses: 1.
- Trial name
- NCT00872859
- Testing
- Implantation of Dermal Matrix substitute
- Where
- United States
- Volunteers
- 128 people
- Sponsor
- University of Utah
Breast Cancer
A Pilot Study to Evaluate Nipple-Areolar Complex (NAC) Sparing Mastectomy
The goal of this study is to study nipple-areolar complex (NAC) sparing mastectomy as an alternative procedure to the standard skin-sparing mastectomy for women who have breast cancer or are at high-risk for developing breast…
- Trial name
- NCT00539227
- Testing
- NAC Sparing Mastectomy, Questionnaire
- Where
- United States
- Volunteers
- 37 people
- Sponsor
- M.D. Anderson Cancer Center