Clinical trials: Mastectomy and Breast Reconstruction
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
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 Cancer, Unilateral
MIAMI Safe Surgery for Multiple Breast Cancers
Sometimes women have more than one breast cancer in the same breast at the same time. These women are usually offered a mastectomy (removal of that breast) and breast reconstruction.
- Trial name
- MIAMI (NCT03514654)
- Testing
- Mastectomy, Therapeutic Mammoplasty
- Where
- 7 sites in United Kingdom
- Volunteers
- 4 people
- Sponsor
- University College, London
Breast Cancer
To Evaluate the Effectiveness and Safety of Mastectomy Combined With Immediate Breast Reconstruction in Breast Cancer (NJMU-Reconstruction Cohort)
The new technology of endoscopic-assisted system, as an emerging technology, has shown certain application prospects in breast surgery.
- Trial name
- NCT06817954
- Testing
- endoscopic-assisted mastectomy and immediate breast reconstruction, mastectomy and immediate breast reconstruction
- Where
- China
- Volunteers
- 800 people
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University
Mastectomy Related Lymphedema, Breast Reconstruction
A Comparison of Dermal Autograft to AlloDerm in Breast Reconstruction
Breast Cancer affects about 1 out of 8 American women. Twenty percent of breast cancer patients undergo some form of breast reconstruction. Several types of reconstructive procedures are available for appropriate patients.
- Conditions
- Mastectomy Related Lymphedema, Breast Reconstruction, Breast Cancer
- Trial name
- NCT01561287
- Testing
- Dermal Autograft, AlloDerm
- Where
- United States
- Volunteers
- 48 people
- Sponsor
- University of Kentucky
Patients With Breast Cancer Requiring Mastectomy and Suitable for Reconstruction
Impact of ADM in Reduction of Surgical Complexity of Breast Reconstructions With Implants (Nava)
The objective of this study is to demonstrate that acellular dermal matrix, Strattice™ Reconstructive Tissue Matrix, can reduce the surgical complexity and post-operative pain of breast reconstructions with implants by avoiding…
- Trial name
- NCT01853436
- Testing
- Strattice™ Reconstructive Tissue Matrix
- Where
- Italy
- Volunteers
- 36 people
- Sponsor
- LifeCell
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
Ventral Hernia, Post-mastectomy Breast Reconstruction
Analysis and Characterization of Biologic Implants
The purpose of this study is to investigate what happens to biologic mesh in the body over time on a molecular level. To date, it is not known what agents, enzymes, or proteins are interacting at the implantation site that…
- Trial name
- NCT01060046
- Where
- United States
- Volunteers
- 241 people
- Sponsor
- Washington University School of Medicine
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 Cancer
Early Rehabilitation After Immediate Reconstruction With TEI in Breast Cancer Patients
The purpose of the study is to find best post-operative rehabilitation protocol after total mastectomy and immediate reconstruction with tissue expander insertion.
- Trial name
- NCT03541161
- Where
- South Korea
- Volunteers
- 115 people
- Sponsor
- Samsung Medical Center
Breast Cancer
Impact of Intraoperative Neurotization on Sensory Recovery of the Nipple and Breast Skin in Patients Undergoing Nipple Sparing Mastectomy With Immediate Implant-Based Reconstruction: NERSENSE, Prospective Randomized Control Study
The purpose of this clinical trial is to demonstrate the superiority of sensory recovery following sensory nerve coaptation compared with no sensory nerve coaptation in patients undergoing nipple-sparing mastectomy with immediate…
- Trial name
- NEARSENSE (NCT07902661)
- Testing
- Nerve anastomosis
- Volunteers
- 110 people
- Sponsor
- Gangnam Severance Hospital
Breast Cancer
A Novel Optical Spectral Imaging System for Imaging Breast Tumor Margins
The goal of this research is to further develop novel optical assay systems for intra operative assessment of tumor margins in partial mastectomy or mastectomy specimens.
- Trial name
- NCT01372631
- Testing
- miniature spectral imaging system, Bench-top optical spectrometer, High resolution microendoscope
- Where
- 2 sites in United States
- Volunteers
- 218 people
- Sponsor
- Duke University
Breast Cancer, Node-positive Breast Cancer
Hypofractionated Regional Nodal Irradiation Clinical Trial for Women With Breast Cancer
Single-arm, phase 2 study evaluating hypofractionated irradiation of breast and regional nodes in women with breast cancer. Patients will be grouped in 3 surgery-related treatment groups: 1) An intact breast following lumpectomy…
- Conditions
- Breast Cancer, Node-positive Breast Cancer, Breast Adenocarcinoma, Invasive Breast Carcinoma
- Trial name
- NCT02515110
- Testing
- External Beam Radiation Therapy
- Where
- 2 sites in United States
- Volunteers
- 137 people
- Sponsor
- Virginia Commonwealth University
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
Wound Complication, Wound Heal
Immunonutrition and Carbohydrate Loading Strategies in Breast Reconstruction
This study is designed to test the following hypothesis: patients undergoing immediate alloplastic and autologous breast reconstruction following mastectomy that receive preoperative immunonutrition will experience a reduction in…
- Conditions
- Wound Complication, Wound Heal, Complications Wound, Surgical Wound Infection
- Trial name
- NCT03764943
- Testing
- Impact Advanced Recovery
- Where
- United States
- Volunteers
- 125 people
- Sponsor
- University of Wisconsin, Madison
Breast Cancer
Dermacell ADM Without Basement Membrane
DermACELL acellular dermal matrix (D-ADM) is the trade name of LifeNet Health's acellular dermal matrix (ADM). LifeNet Health will remove the basement membrane from the D-ADM and this product will be compared to FlexHD® Pliable…
- Trial name
- NCT03667560
- Testing
- Dermacell ADM without basement membrane, FlexHD
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- University of Virginia
Post-Mastectomy Breast Deformity (Disorder)
Investigate Wound Healing, Aesthetics & Pt Satisfaction Post NAC Reconstruction Using a Decellularized Donor NAC Graft
To evaluate the wound healing response following nipple-areolar complex (NAC) reconstruction with a decellularized donor NAC graft (DCLNAC)
- Trial name
- NCT05484934
- Testing
- Regenerative post mastectomy surgery
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- BioAesthetics
Female Breast Cancer, Post Operative Pain
Pulsed Electromagnetic Fields for Analgesia Post Mastectomy
Study aim is to test AlgoCare, a device that uses the technology PEMF (Pulsed ElectroMagnetic Fields) for the treatment of postoperative pain in oncological breast surgery, in order to demonstrate that the use of Algocare in the…
- Trial name
- Algocare (NCT06331793)
- Testing
- Active AlgoCare, Non-active AlgoCare
- Where
- Italy
- Volunteers
- 160 people
- Sponsor
- European Institute of Oncology
Breast Cancer Surgery, Reconstruction Breast Surgery
Improvement in Breast Skin Sensibility After Breast Reconstruction: a Comparison of 3 Surgical Techniques
The goal of this clinical trial is to learn if nerve sutures in free flap breast reconstruction can optimize sensibility in the reconstructed breast in patients opting for DIEP flap breast reconstruction due to breast cancer or…
- Conditions
- Breast Cancer Surgery, Reconstruction Breast Surgery, Sensitization, DIEP Flap Breast Reconstruction
- Trial name
- S-DIEP (NCT06930378)
- Testing
- Nerve Suture
- Where
- Switzerland
- Volunteers
- 63 people
- Sponsor
- Patricia Esther Engels
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