Clinical trials: Mastectomy
Breast Cancer, Breast Reconstruction
Evaluation of the Cook Biodesign® Nipple Reconstruction Cylinder (NRC)
Patients with a desire for nipple reconstruction following breast cancer and breast reconstruction will receive a surgical procedure to reconstruct one or both nipples utilizing the COOK Biodesign® Nipple Reconstruction Cylinder.
- Conditions
- Breast Cancer, Breast Reconstruction, Nipple Reconstruction
- Trial name
- NRC (NCT01216319)
- Testing
- Nipple reconstruction
- Where
- 4 sites in United States
- Volunteers
- 50 people
- Sponsor
- Cook Group Incorporated
Invasive Breast Cancer
Mometasone Furoate 0.1% Versus Eucerin on Moderate to Severe Skin Toxicities in Breast Cancer Patients Receiving Postmastectomy Radiation
The purpose of this study is to find out if the effect of mometasone furoate is any different from Eucerin in decreasing the severity of redness of the skin during irradiation, preventing the skin from peeling, or reducing the…
- Trial name
- NCT01856543
- Testing
- Eucerin, Mometasone Furoate 0.1%
- Where
- 6 sites in United States
- Volunteers
- 143 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
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
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
Invasive Breast Cancer
Proton Radiation Therapy for Invasive Breast Cancer Following Mastectomy
In this study we are looking at a type of radiation called proton radiation which is known to spare surrounding tissue and organs from radiation.
- Trial name
- NCT01340495
- Testing
- Proton Radiation
- Where
- United States
- Volunteers
- 70 people
- Sponsor
- Massachusetts General Hospital
Breast Cancer, Postoperative Pain
Comparison of Pre-op and Post-op Pectoralis Nerve Block
The investigators will compare whether patients will have better pain control if they were to receive (PEC I/II block) before surgery or after mastectomy.
- Conditions
- Breast Cancer, Postoperative Pain, Anesthesia, Nerve Block
- Trial name
- NCT03653988
- Testing
- PEC I/II blocks by anesthesiologist - pre-operative, PEC I/II blocks by surgeon - intra-operative
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- Melinda Seering
Breast Carcinoma, Breast Disorder
Blossom Smart Expander Technology in Breast Reconstruction in Participants With Breast Cancer Undergoing Mastectomy
This phase 1 trial studies how well Blossom Smart Expander Technology works in breast reconstruction in participants with breast cancer undergoing mastectomy.
- Trial name
- NCT03657069
- Testing
- Blossom, Breast-Q -Reconstruction module (preoperative) version 2.0 satisfaction with breasts questionnaire
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Stanford University
Hematoma Postoperative
A Randomized Control Trial Assessing the Effect of Topical Tranexamic Acid on Risk of Hematoma in Breast Surgery
This trial is being completed to evaluate the safety and efficacy of topical tranexamic acid use in preventing hematomas in routine breast plastic surgery operations.
- Trial name
- NCT05441592
- Testing
- Tranexamic acid injection, No additional irrigation
- Where
- United States
- Volunteers
- 107 people
- Sponsor
- University of Michigan
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
Postoperative Pain
Effect of Postoperative Single Dose of Ketamine on Pain After Mastectomy
This is a randomized, single blinded, placebo-controlled trial to study the effectiveness of a subanesthetic dose (0.6mg/kg) of ketamine versus placebo (saline) on postoperative pain on adult women undergoing mastectomy.
- Trial name
- NCT04831736
- Testing
- Ketamine
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- NYU Langone Health
Breast Cancer, Mastectomy
Acellular Dermal Matrix in Tissue Expander Breast Reconstruction: A Prospective, Randomized, Clinical Trial Comparing SurgiMend PRS and AlloDerm RTU
The purpose of this study is to assess the relative performance and complication rates between the AlloDerm RTU and SurgiMend PRS products as well as the relative economics of these two treatment options.
- Trial name
- NCT01781299
- Testing
- AlloDerm RTU, SurgiMend PRS
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- University of Pittsburgh
Breast Cancer, Cancer of the Breast
Real-time Intraoperative Breast Cancer Visualization for Margin Assessment
The investigators' preclinical data have demonstrated the feasibility of fluorescence-guided tumor resection by Cancer Vision Goggles (CVG) with LS301 in animal models.
- Trial name
- NCT02807597
- Testing
- LS301, Cancer Vision Goggles and standard fluorescence imaging systems, Surgery
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Samuel Achilefu
Breast Cancer
Surgical Site Infection With 0.05% Chlorhexidine (CHG) Compared to Triple Antibiotic Irrigation
The investigators intend to perform a prospective randomized study and compare the incidence of surgical wound infection between mastectomy wounds irrigated with triple antibiotic solution (one side) and 0.05% CHG (opposite side)…
- Trial name
- NCT02395614
- Testing
- Chlorhexidine irrigation, triple antibiotic irrigation
- Where
- United States
- Volunteers
- 88 people
- Sponsor
- Vanderbilt University Medical Center
Breast Cancer
Psychosocial Outcomes and Contralateral Prophylactic Mastectomy (CPM)
The goal of this research study is to learn more about how different treatment decisions may influence the quality of life in women with breast cancer.
- Trial name
- NCT02263014
- Testing
- Questionnaires
- Where
- 2 sites in United States
- Volunteers
- 345 people, healthy volunteers welcome
- Sponsor
- M.D. Anderson Cancer 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
Mastectomy
Reduction of Post Mastectomy Pain With the Jacki® Recovery Jacket
This research study is studying a garment called the Jacki® recovery jacket that can be worn after surgery as a possible way to manage pain from surgical drains.
- Trial name
- NCT02976103
- Testing
- Jacki Recovery jacket, Standard Care Pain medicine/management
- Where
- 2 sites in United States
- Volunteers
- 139 people
- Sponsor
- Dana-Farber Cancer Institute
Mastectomy
PEAK PlasmaBlade™ 4.0 Versus Traditional Electrosurgery in Mastectomy
The objective of this clinical study is to evaluate the incidence of partial skin necrosis following modified-radical mastectomy with or without same-day (two-stage) reconstruction with the PEAK PlasmaBlade 4.0; to monitor and…
- Trial name
- PRECISE (NCT00943605)
- Testing
- Scalpel and Traditional Electrosurgery, PEAK PlasmaBlade
- Where
- 4 sites in United States
- Volunteers
- 60 people
- Sponsor
- Medtronic Surgical Technologies
Inflammatory Breast Cancer, Invasive Ductal Breast Carcinoma
Accelerated Radiation Therapy After Surgery in Treating Patients With Breast Cancer
This phase II trial studies how well giving accelerated radiation therapy (RT) after surgery works in treating patients with breast cancer. RT uses high energy x rays to kill tumor cells.
- Conditions
- Inflammatory Breast Cancer, Invasive Ductal Breast Carcinoma, Invasive Lobular Breast Carcinoma, Mucinous Ductal Breast Carcinoma
- Trial name
- NCT01417286
- Testing
- External beam radiation therapy
- Where
- 2 sites in United States
- Volunteers
- 69 people
- Sponsor
- Rutgers, The State University of New Jersey
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
Pain, Postoperative
Perioperative Administration of Pregabalin for Pain After Mastectomy
The investigators hypothesize that pregabalin will decrease post-operative pain scores and analgesic use following total mastectomy compared to placebo.
- Trial name
- NCT00938548
- Testing
- Pregabalin
- Where
- South Korea
- Volunteers
- 70 people
- Sponsor
- Severance Hospital