Clinical trials: Post-mastectomy Breast Reconstruction
Breast Asymmetry Between Native Breast and Reconstructed Breast
Performance of OrbiSymm in Subjects Referred to Contra Lateral Breast Symmetrisation
This is a Phase IV, multicenter, open label, non-randomized comparative group study to assess the safety and performance of the OrbiSymm system in subjects referred to contra lateral breast symmetrization involving a breast…
- Trial name
- NCT02649283
- Testing
- OrbiSymm device, Breast symmetrisation
- Where
- Italy
- Volunteers
- 60 people
- Sponsor
- Orbix Medical Ltd.
Breast Cancer
Implant-based Breast Reconstruction and Mastectomy With Fat Grafting After Breast Conserving Surgery and Radiotherapy
Higher rates of complications and poorer cosmetic outcomes have been reported after salvage mastectomy and implant-based versus autologous reconstruction in patients previously exposed to radiation therapy (i) on the breast as…
- Trial name
- NCT06119633
- Testing
- Immediate tissue expander and lipofilling after mastectomy
- Where
- 2 sites in Italy
- Volunteers
- 163 people
- Sponsor
- Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
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
Breast Neoplasm
Effect of Pectoral Nerve Block on Post-op Pain in Patients Undergoing Mastectomy and Immediate Reconstruction
Patients undergoing total mastectomy with immediate breast reconstruction with a tissue expander or implant under general anesthesia will be randomly assigned to the addition of a pectoral nerve block or no regional block.
- Trial name
- NCT02913573
- Testing
- Ultrasound, 0.25% bupivacaine
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Huntington Memorial Hospital
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
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
Pain, Postoperative, Non-Opioid Pain Management
Virtual Reality After Breast Reconstruction Surgery
This is a pilot study of virtual reality (VR) non-opioid management for women undergoing mastectomy and implant-based reconstruction.
- Conditions
- Pain, Postoperative, Non-Opioid Pain Management, Virtual Reality
- Trial name
- VR4BR (NCT03801616)
- Testing
- Virtual Reality
- Where
- United States
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Cedars-Sinai Medical Center
Breast Cancer
The Effect of Digital Technology-Supported Education on Patients Undergoing Breast Reconstruction After Mastectomy: A Randomized Controlled Study
The goal of this randomized, controlled study is to test the effectiveness of digital technology-supported education on patients undergoing breast reconstruction after mastectomy.
- Trial name
- NCT06166953
- Testing
- digital technology-supported education
- Where
- Turkey (Türkiye)
- Volunteers
- 38 people
- Sponsor
- Baskent University
Breast Neoplasm Female, Complication of Radiation Therapy
Delayed-immediate Versus Delayed Breast Reconstruction in Breast Cancer Patients With Mastectomy and Radiation Therapy
In breast cancer patients treated by mastectomy and adjuvant post-mastectomy radiation therapy (PMRT) reconstruction is often delayed until 6 - 12 month after completion of chemotherapy and PMRT, due to high risk of complication.
- Conditions
- Breast Neoplasm Female, Complication of Radiation Therapy, Breast Implant; Complications
- Trial name
- NCT03730922
- Testing
- Delayed-immediate reconstruction, Delayed reconstruction
- Where
- 8 sites in Denmark
- Volunteers
- 590 people
- Sponsor
- Danish Breast Cancer Cooperative Group
Breast Cancer
Delayed-Delayed Breast Reconstruction
The goal of this clinical research study is to learn if delayed-delayed breast reconstruction in women who require post-mastectomy radiation therapy will improve cosmetic outcomes and result in fewer complications compared to the…
- Trial name
- NCT01256528
- Testing
- Delayed Breast Reconstruction
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- M.D. Anderson Cancer Center
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
Breast Cancer
Compare Outcomes Between Two Acellular Dermal Matrices
This study will evaluate the performance of Alloderm RTU medium (LifeCell) vs. Cortiva 1mm Allograft Dermis (RTI Surgical®, Inc.).
- Trial name
- NCT02891759
- Testing
- Alloderm RTU, Cortiva 1mm Allograft Dermis, Skin or nipple-sparing mastectomy
- Where
- United States
- Volunteers
- 320 people
- Sponsor
- Washington University School of Medicine
Sensation Disorder
A Comparative Study of Nipple Sensation Preservation After Nipple-Sparing Mastectomy With Conventional, Endoscopic, Robotic Techniques
The goal of this comparative study is to learn how different surgical methods affect nipple and skin sensation after nipple-sparing mastectomy (NSM).
- Trial name
- NIPSENSE (NCT07062458)
- Testing
- Nipple Sensation Assessment
- Where
- Italy
- Volunteers
- 90 people
- Sponsor
- Candiolo Cancer Institute - IRCCS
Mastectomy, Breast Reconstruction
CiNPWT Using in Mastectomy Wound Care After DIEP Flaps for Breast Reconstruction
Background: Closed-incision negative pressure wound therapy (ciNPWT) is effective in reducing postoperative complications, yet its use in free flap breast reconstruction mastectomy wound remains controversial due to concerns that…
- Conditions
- Mastectomy, Breast Reconstruction, Closed-Incision Negative Pressure Therapy
- Trial name
- NCT07546968
- Testing
- Closed-Incision Negative Pressure Wound Therapy (CiNPWT)
- Where
- Taiwan
- Volunteers
- 253 people
- Sponsor
- Chiayi Christian Hospital
Breast Cancer, Mastectomy
Post-Operative Outcomes of Low Thermal Dissection vs. Traditional Electrosurgery
Low thermal dissection devices have been introduced as a tool to improve surgical outcomes. PlasmaBlade, a low thermal dissection device, has shown to be associated with effective cutting, and significantly lower temperature than…
- Conditions
- Breast Cancer, Mastectomy, Perfusion; Complications, Hemostasis
- Trial name
- NCT03711916
- Testing
- PlasmaBlade 3.0S
- Where
- 2 sites in United States
- Volunteers
- 20 people
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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
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
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
Breast Carcinoma
A 3D-Printed External Breast Prosthesis for the Improvement of Patient-reported Outcomes Among Breast Cancer Patients That Underwent a Mastectomy Without Reconstruction
This clinical trial evaluates whether a three-dimensional (3D)-printed external breast prosthesis improves patient-reported outcomes (PRO) among breast cancer patients that underwent surgical removal of the breast (mastectomy)…
- Trial name
- NCT07047872
- Testing
- Computer-Aided Diagnosis, Prosthetics Intervention, Questionnaire Administration
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Mayo Clinic
Seroma
Arnica Montana and Bellis Perennis for Prevention of Seroma After Mastectomy
Arnica montana and Bellis perennis for Prevention of Seroma Following Mastectomy.
- Trial name
- HOM (NCT03512639)
- Testing
- Homeopathic Medication
- Volunteers
- 55 people
- Sponsor
- Shaare Zedek Medical Center