Clinical trials: Mastectomy
Mastectomy and Breast Reconstruction
Efficacy Study of Single Stage Breast Reconstruction in Female Participants With Mastectomy
The purpose of this study was to compare the efficacy of immediate single-stage post-mastectomy breast reconstruction with Strattice Reconstructive Tissue Matrix (Strattice) as compared to immediate two-stage post-mastectomy…
- Trial name
- ESSBR (NCT01910298)
- Testing
- Breast Reconstruction, Direct to Implant (DTI) with Strattice™, Two Stage Breast Reconstruction
- Where
- 18 sites in France, Germany and 1 more
- Volunteers
- 131 people
- Sponsor
- LifeCell
Breast Cancer
One-stage Breast Reconstruction Using Dermal Matrix/Implant Versus Two-stage Expander/Implant Procedure
Currently the two-stage tissue expander/implant (TE/I) technique is the standard breast reconstructive option for breast cancer patients selected for immediate, skin-sparing mastectomy.
- Trial name
- AllodermRCT (NCT00956384)
- Testing
- One-stage dermal matrix/implant procedure, Two-stage tissue expander/implant procedure
- Where
- 4 sites in Canada
- Volunteers
- 198 people, healthy volunteers welcome
- Sponsor
- University Health Network, Toronto
Radiation Dermatitis, Breast Cancer
Topical Dermaprazole for Radiation Dermatitis in Breast Cancer Patients (TOPAZ)
Radiotherapy is a mainstay of treatment in breast cancer treatment, in the adjuvant setting. Radiation dermatitis occurs in up to 65% of these patients; currently, there is no standard of care for this treatment-related toxicity.
- Trial name
- NCT05269160
- Testing
- Dermaprazole 1%, Dermaprazole 2%
- Where
- 2 sites in United States
- Volunteers
- 3 people
- Sponsor
- Baylor College of Medicine
Breast-cancer
Seroma Formation After Modified Radical Mastectomy With Flap Fixation Technique in Breast Cancer Patients
The goal of this clinical trial is to evaluate the effectiveness of mastectomy flap fixation in breast cancer patients. The main questions it aims to answer are: To compare seroma formation after mastectomy flap fixation with…
- Trial name
- NCT06243796
- Testing
- Flap fixation technique
- Where
- Thailand
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Nakhon Phanom Hospital
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
A Pilot Trial to Assess the Impact of Acupuncture on Post-mastectomy Pain, Nausea, Anxiety and Ability to Cope
The purpose of the study is to compare the effect of acupuncture to the standard of care (control group) on pain, nausea, anxiety, ability to cope, costs and length of hospital stay in post-mastectomy patients at Abbott…
- Trial name
- NCT02122796
- Testing
- Acupuncture
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Allina Health System
Pain, Postoperative
Pectoralis (II) Block With Liposomal Bupivacaine vs Bupivacaine for Breast Surgery
This is a randomized controlled pilot study evaluating length of pain control with either liposomal bupivacaine or with bupivacaine plus decadron after PEC II injection in patients having bilateral mastectomies with immediate…
- Trial name
- NCT03383198
- Testing
- Liposomal bupivacaine right injection, Liposomal bupivacaine left injection
- Where
- United States
- Volunteers
- 5 people, healthy volunteers welcome
- Sponsor
- Prisma Health-Upstate
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
Stage I Breast Cancer, Stage II Breast Cancer
Comparison of Use of Indocyanine Green and 99mTc-labeled Radiotracer for Axillary Lymphatic Mapping in Patients With Breast Cancer
This clinical trial will enroll up to 130 adult women with a confirmed diagnosis of clinical stage 1 or 2 breast cancer who are undergoing breast cancer surgery with lumpectomy or mastectomy and planned axillary sentinel node…
- Trial name
- NCT02419807
- Testing
- Indocyanine Green Solution, Technetium Tc-99m Sulfur Colloid, Lymphoscintigraphy
- Where
- United States
- Volunteers
- 102 people
- Sponsor
- Case Comprehensive Cancer Center
Mastectomy, Upper Limb Amputation Below Elbow
Cryoanalgesia to Prevent Acute and Chronic Pain Following Surgery: A Randomized, Double-Masked, Sham-Controlled Study
The ultimate objective of the proposed line of research is to determine if cryoanalgesia is an effective adjunctive treatment for pain in the period immediately following various painful surgical procedures; and, if this…
- Conditions
- Mastectomy, Upper Limb Amputation Below Elbow, Upper Limb Amputation Above Elbow, Lower Limb Amputation Below Knee
- Trial name
- NCT03578237
- Testing
- Cryoneurolysis (active)
- Where
- United States
- Volunteers
- 99 people
- Sponsor
- University of California, San Diego
Breast Cancer
Optimizing Decision Making About Breast Reconstruction After Mastectomy: A Patient-Centered Approach
Although clinical decision tools (CDTs) exist for a variety of treatments, CDTs designed to support personalized breast reconstruction decisions, particularly about type and timing of reconstruction, are lacking.
- Trial name
- NCT03346161
- Testing
- Usual care American Society of Plastic Surgeons booklet "Breast Reconstruction", Decision tool, Usual Care Group - Outcome Measures
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- Washington University School of Medicine
Breast Cancer, Mastectomy
Mastectomy Flap Temperature Study
The purpose of this research study is to measure tissue temperatures and generate a prospective database of participants undergoing mastectomy with or without breast reconstruction at Wake Forest Baptist Hospital (WFBH) in order…
- Trial name
- NCT05395936
- Testing
- Myocardial Probe Temperature Screen, Data Collection
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- Wake Forest University Health Sciences
Breast Cancer, Mastectomy
Single Versus Double Drains After Mastectomy
It is not known whether decreasing the number of drains used decreases patients' discomfort and duration of hospital stay without increasing seroma formation after mastectomies. Hypothesis.
- Trial name
- NCT02202252
- Testing
- Insertion of a single drain, Insertion of double drains, Ultrasonography after removal of the drains
- Where
- Turkey (Türkiye)
- Volunteers
- 60 people
- Sponsor
- Ankara Diskapi Training and Research Hospital
Breast Cancer
Efficacy of Digital Breast Tomosynthesis + Standard 2- Dimensional Mammography in Breast Cancer
The purpose of this study is to determine if a 3-dimensional mammogram (DBT) may provide additional information to evaluate the extent of disease and additional findings that would aid in staging a new breast cancer patient.
- Trial name
- NCT03190083
- Testing
- 2-dimensional mammogram, digital breast tomosynthesis (DBT)
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Case Comprehensive Cancer Center
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
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
Intraductal Carcinoma and Lobular Carcinoma in Situ
Management of Ductal Carcinoma in Situ or Pure Micro-invasive Extended Breast
When invasive components are discovered at mastectomy for vacuum-assisted biopsy (VAB)-diagnosed ductal carcinoma in situ (DCIS), the only option available is axillary lymph node dissection (ALND).
- Trial name
- CINNAMOME (NCT01841749)
- Testing
- sentinel node biopsy and mastectomy
- Where
- France
- Volunteers
- 228 people
- Sponsor
- Institut Bergonié
Breast Cancer
Use of Dermal Matrix in Breast Reconstruction
We propose to evaluate the question of whether there is a significant difference between the traditional method of serratus flap tissue expander reconstruction and the acellular matrix method.
- Trial name
- NCT00692692
- Testing
- DermaMatrix, standard of care tissue expander breast reconstruction surgery after mastectomy
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- Vanderbilt University
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 Cancer
Bioprosthetic Mesh to Expand the Lower Pole in Tissue Expander Reconstruction
The goal of this clinical research study is to learn if the complication rate and post-surgical appearance differ based on what type of mesh is used for breast reconstruction surgery.
- Trial name
- NCT01310075
- Testing
- Alloderm, Surgimend
- Where
- United States
- Volunteers
- 90 people
- Sponsor
- M.D. Anderson Cancer Center