Clinical trials: Breast Reconstruction Following Mastectomy
Breast Cancer, Breast Reconstruction
Autologous Fat Grafting for Total Breast Reconstruction in Irradiated Breast Cancer Patients
The goal of this clinical trial is to learn whether autologous fat transfer (AFT) is as effective and safe as Deep Inferior Epigastric Perforator (DIEP) flap breast reconstruction in irradiated breast cancer patients following…
- Conditions
- Breast Cancer, Breast Reconstruction, Breast Reconstruction After Mastectomy, Breast Cancer Radiation
- Trial name
- AFT-R (NCT07641985)
- Testing
- Autologous fat transfer, Deep inferior epigastric perforator flap
- Where
- Netherlands
- Volunteers
- 280 people
- Sponsor
- Maastricht University Medical Center
Ductal Breast Carcinoma, Invasive Breast Carcinoma
Hypofractionated Radiation Therapy After Mastectomy in Preventing Recurrence in Patients With Stage IIa-IIIa Breast Cancer
This randomized phase III trial studies how well hypofractionated radiation therapy works in preventing recurrence in patients with stage IIa-IIIa cancer who have undergone mastectomy.
- Conditions
- Ductal Breast Carcinoma, Invasive Breast Carcinoma, Lobular Breast Carcinoma, Medullary Breast Carcinoma
- Trial name
- NCT03414970
- Testing
- Radiation Therapy, Questionnaire Administration, Quality-of-Life Assessment
- Where
- 859 sites in United States, Canada
- Volunteers
- 898 people
- Sponsor
- Alliance for Clinical Trials in Oncology
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 Neoplasms
Does Autologous Fat Transplantation Improve Results and Reduce Complications in Breast Reconstruction With Implants?
The purpose of this study is to determine if autologous fat transplantation as a pre-treatment gives better results in breast reconstruction with implants after mastectomy and radiotherapy.
- Trial name
- NCT02637635
- Testing
- Autologous fat transplantation, Expander prosthesis
- Where
- Sweden
- Volunteers
- 45 people
- Sponsor
- Karolinska Institutet
Breast Reconstruction After Mastectomy
A Comparative Study of Delayed Endoscopic DTI and Autologous Flap Reconstruction Post-Mastectomy
In China, low breast-conserving surgery rates and historically minimal immediate reconstruction following mastectomy have resulted in a significant population of women living without a breast, often leading to long-term…
- Trial name
- DEDIA (NCT07602868)
- Volunteers
- 263 people
- Sponsor
- West China Hospital
Postoperative Complications, Recurrence
Surgical and Oncologic Outcomes After Robotic Nipple Sparing Mastectomy and Immediate Reconstruction
Robotic mastectomy with immediate reconstruction was introduced by Toesca et al. in 2015. Since then, several studies have reported the safety and feasibility of robotic nipple-sparing mastectomy with immediate reconstruction.
- Conditions
- Postoperative Complications, Recurrence, Breast Neoplasms, Breast Cancer
- Trial name
- SORI (NCT04108117)
- Testing
- Robotic nipple sparing mastectomy
- Where
- South Korea
- Volunteers
- 659 people, healthy volunteers welcome
- Sponsor
- Severance Hospital
Patient Satisfaction
Unilateral Secondary Breast Reconstruction Using a Muscle-sparing Pedicled Dorsal Flap After Breast Cancer
The use of pedicled dorsal flaps sparing the latissimus dorsi muscle (TDAP and MSLD flap) is a well-described reconstruction method in breast reconstruction after breast cancer.
- Trial name
- RMSU-LDPEM (NCT06230250)
- Where
- France
- Volunteers
- 22 people
- Sponsor
- University Hospital, Brest
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
Mastectomy, Breast Reconstruction
Sensation After Nipple Sparing Mastectomy and Breast Reconstruction With or Without Neurotized Free Tissue Transfer
Tissue Expander/Implant Reconstruction: The purpose of this study is to determine how and when nerve sensation to the breast skin returns after mastectomy.
- Trial name
- NCT03135392
- Testing
- Breast Reconstruction with Artificial Implant, Autologous Breast Reconstruction, Neurotization
- Where
- United States
- Sponsor
- Case Comprehensive Cancer Center
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
Nipple-sparing Mastectomy, Prophylactic Mastectomy
Pilot Study of Single-port Robot-assisted Nipple-sparing Mastectomy
Nipple-sparing mastectomy (NSM) is indicated for breast cancer requiring total mastectomy and without nipple involvement by cancer.
- Conditions
- Nipple-sparing Mastectomy, Prophylactic Mastectomy, Breast Cancer, BRCA1 Mutation
- Trial name
- NCT05448963
- Testing
- da Vinci SPⓇ Single-port System
- Where
- Taiwan
- Volunteers
- 30 people
- Sponsor
- Chang Gung Memorial Hospital
Breast Cancer
Patient Preferences for Breast Reconstruction After Mastectomy
Deciding whether or not to have breast reconstruction after mastectomy is highly challenging for many patients. This study will examine patients' decisions about reconstruction and the effects of reconstruction on quality of life…
- Trial name
- NCT01488357
- Where
- United States
- Volunteers
- 145 people
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
Breast Cancer
SurgiMend in Two-stage Implant-based Breast Reconstruction in Patients With Pre-Mastectomy Radiotherapy
This is a prospective clinical study comparing two-stage breast reconstruction following mastectomy with and without the use of SurgiMend® PRS fetal bovine collagen matrix in patients with pre-mastectomy radiation therapy.
- Trial name
- NCT01959867
- Testing
- SurgiMend® PRS, No Intervention
- Sponsor
- Integra LifeSciences Corporation
Breast Cancer
Cosmetic Result/Toxicity in Post-Mastectomy Immediate Reconstruction Expander+RT
This research study is being done to carefully evaluate the effect of giving radiation therapy after temporary breast reconstruction.
- Trial name
- NCT01664091
- Testing
- post-mastectomy radiation therapy (PMRT), tissue expander (TE), acellular dermal matrix (ADM)
- Where
- 2 sites in United States
- Volunteers
- 32 people
- Sponsor
- Dana-Farber Cancer Institute
Nonmalignant Breast Conditions, Breast Cancer
Trial of Drain Antisepsis After Tissue Expander Breast Reconstruction
Surgical site infection (SSI) after breast and axillary surgery occurs more often than for other clean surgical procedures. Infection in the setting of a tissue expander can be devastating and can lead to early implant loss and…
- Trial name
- NCT01286168
- Testing
- Sodium hypochlorite (Dakin's Solution), Chlorhexidine gluconate disk, Control
- Where
- 2 sites in United States
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- Mayo Clinic
Breast Reconstruction
Prosthetic Breast Reconstruction After Mastectomy
Breast cancer represents a disabling diagnosis for women, and the related destructive surgical intervention of mastectomy inevitably affects their social, relational and working life.
- Trial name
- BrREC2020 (NCT06774352)
- Where
- Italy
- Volunteers
- 200 people
- Sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
Postoperative Pain, Postoperative Nausea and Vomiting
Pre-op Paravertebral Blocks to Decrease Post-op Pain Following Mastectomy With Immediate Tissue Expander (TE) Reconstruction
Primary Objective To determine if post-operative static pain scores differ between women undergoing bilateral mastectomy followed by bilateral immediate tissue expander reconstruction randomized either to ropivacaine- (treatment)…
- Conditions
- Postoperative Pain, Postoperative Nausea and Vomiting, Quality of Life
- Trial name
- NCT02161705
- Testing
- Ropivacaine, Saline
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- Johns Hopkins University
Breast Carcinoma
Skin Sparing Mastectomy and Immediate Breast Reconstruction With Latissimus Dorsi Flap After Neoadjuvant Chemotherapy and Radiotherapy (M-RIC)
The aim of the study is to evaluate the feasibility and morbidity of skin sparing mastectomy and immediate breast reconstruction with latissimus dorsi flap after neoadjuvant chemotherapy and radiotherapy in invasive breast…
- Trial name
- M-RIC (NCT01199354)
- Testing
- Mastectomy, preservation of the skin envelope,followed by immediate reconstruction with autologous latissimus dorsi flap.
- Where
- 11 sites in France
- Volunteers
- 80 people
- Sponsor
- Clinique Clementville
Breast Reconstruction After Mastectomy
Thermal Preconditioning in Mastectomy Patients With Immediate Breast Reduction
The purpose of this research study is to understand patient experiences and the feasibility of using a breast heat preconditioning device (Plexaa BLOOM43), designed to improve postoperative outcomes when used prior to mastectomy…
- Trial name
- NCT07516483
- Testing
- 1 Cycle Thermal Preconditioning, 3 Cycles Thermal Preconditioning, No Intervention
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Wake Forest University Health Sciences
Post Mastectomy
Scapular Mobilization and Proprioceptive Neuromuscular Facilitation on Shoulder Dysfunction After Latissimus Dorsi Flap Breast Reconstruction
this study will be conducted to investigate the effect of scapular mobilization and scapular Proprioceptive neuromuscular facilitation on shoulder dysfunction after latissimus dorsi flap breast reconstruction
- Trial name
- PNF (NCT07547982)
- Testing
- scapular mobilization and scapular proprioceptive neuromuscular facilitation exercises, traditional physical therapy
- Volunteers
- 36 people
- Sponsor
- Cairo University