Clinical trials: Mastectomy and Breast Reconstruction
Breast Cancer, Psychosocial Effects of Cancer and Its Treatment
Factors Affecting Decisions About Breast Reconstruction After Mastectomy in Black and Latina Women
RATIONALE: Learning about the reasons for choosing to have, or not to have, breast reconstruction after mastectomy for breast cancer may help doctors understand why black or Latina women may or may not undergo breast…
- Trial name
- NCT00519974
- Testing
- counseling intervention, study of socioeconomic and demographic variables, management of therapy complications
- Where
- 6 sites in United States
- Volunteers
- 55 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Breast Reconstruction, Breast Cancer
Evaluation of Well Being and Patient Reported Outcomes After Robotic Single-port Nipple Sparing Mastectomy and Implant Reconstruction
This study is being carried out to better understand how different types of mastectomy surgeries affect women's recovery, satisfaction, and overall well-being after breast cancer surgery and reconstruction.
- Conditions
- Breast Reconstruction, Breast Cancer, Hereditary Breast/Ovarian Cancer (brca1, brca2), Robotic Surgery
- Trial name
- Reborn-i (NCT07236359)
- Testing
- Intervention, Standard open nipple sparing mastectomy with immediate implant-based reconstruction
- Volunteers
- 108 people
- Sponsor
- Beaumont Hospital
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
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
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
Breast Cancer, Implant Breast Reconstruction
Hypofractionated vs. Conventionally Fractionated Postmastectomy Radiotherapy After Implant-Based Reconstruction
This is a prospective, randomized controlled, non-inferiority clinical trial designed to compare the outcomes of hypofractionated radiotherapy versus conventionally fractionated radiotherapy following mastectomy and implant-based…
- Trial name
- NCT07835139
- Testing
- ConvRT, HypoRT
- Where
- China
- Volunteers
- 534 people
- Sponsor
- Fudan University
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
Breast Cancer Invasive
Prospective, Multicentric Study Evaluating the Surgical Treatment by Mastectomy With Immediate Prosthetic Breast Reconstruction in Patients With Breast Cancer and Receiving Adjuvant Therapy by TomoTherapy +/-Chemotherapy.
Prospective, multicentric, non-randomized phase II study evaluating the surgical treatment by mastectomy with immediate prosthetic breast reconstruction in patients with breast cancer and receiving adjuvant therapy by TomoTherapy…
- Trial name
- MARTA (NCT03627988)
- Testing
- Mastectomy with Immediate prosthetic breast reconstruction and adjuvant tomotherapy
- Where
- 2 sites in France
- Volunteers
- 66 people
- Sponsor
- Institut Claudius Regaud
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
Breast Cancer, Mastectomy
Same-Day Awake Mastectomy With Immediate Breast Reconstruction for Patients With Breast Cancer
The goal of this clinical trial is to learn if the AMADeuS care pathway is as safe as usual hospital care and works as well for pain control in women having mastectomy with immediate prepectoral breast reconstruction.
- Conditions
- Breast Cancer, Mastectomy, Prepectoral Breast Reconstruction, ERAS Programmes
- Trial name
- AMADeuS (NCT07510698)
- Testing
- AMADeuS Perioperative Pathway, Usual Perioperative Care
- Where
- Italy
- Volunteers
- 100 people
- Sponsor
- University of Rome Tor Vergata
Breast Cancer
Impact of Radiotherapy on Patients Undergoing DIEP Flap Breast Reconstruction
The investigators intend to undertake a study to investigate the effect of radiotherapy on deep inferior epigastric perforator flap reconstructions (DIEP).
- Trial name
- NCT03072316
- Testing
- 3D surface imaging, semi-structured interview, applanation tonometry
- Where
- United Kingdom
- Volunteers
- 300 people
- Sponsor
- Royal Marsden NHS Foundation Trust
Breast Reconstruction After Mastectomy, Breast Neoplasm
Post Market Clinical Follow Up to "Patient Reported Outcome" Using a Titanised Polypropylene Mesh (TiLOOP® Bra Pocket)
"PRO-Pocket" - International prospective multicentre Post Market Clinical Follow Up to "Patient reported outcome" in primary or secondary breast reconstruction after mastectomy using a titanised polypropylene mesh (TiLOOP® Bra…
- Conditions
- Breast Reconstruction After Mastectomy, Breast Neoplasm, Breast Cancer, Breast Diseases
- Trial name
- PRO-Pocket (NCT03868514)
- Testing
- TiLOOP® Bra Pocket
- Where
- 12 sites in Austria, Germany
- Volunteers
- 313 people, healthy volunteers welcome
- Sponsor
- pfm medical gmbh
Breast Neoplasms, Breast Carcinoma
Preoperative Radiation Therapy and Immediate Breast Reconstruction
The goal of this phase III randomized controlled trial (PRADAIIBE) is to assess if preoperative radiation therapy (Preop-RT) combined with immediate breast reconstruction (IBR) can safely improve both aesthetic and quality of…
- Conditions
- Breast Neoplasms, Breast Carcinoma, Breast Adenocarcinoma, Cancer
- Trial name
- PRADAIIBE (NCT06739655)
- Testing
- Preoperative radiotherapy, Postoperative radiotherapy, Immediate breast reconstruction
- Where
- 6 sites in Belgium
- Volunteers
- 180 people
- Sponsor
- Cancer Research Antwerp
The Impact of Adipose Tissue Quality on Fat Graft Retention
Lipofilling: Optimal Harvesting Techniques for Breast Reconstruction After Mastectomy in Plastic Aesthetic and Reconstructive Surgery
The primary aim of this project is to standardize the method for lipofilling by identifying the best technique. In this context, the study will investigate the impact of adipose tissue composition and ideal quantity of the…
- Trial name
- LipoTech (NCT05286424)
- Testing
- fat grafting
- Where
- Austria
- Volunteers
- 10 people
- Sponsor
- Medical University of Graz
Breast Cancer, Breast Reconstruction
Endoscopic Nipple-Sparing Mastectomy (E-NSM) With Immediate Multistage Autologous Fat Grafting(IMAFG) for Total Breast Reconstruction Via the Axillary Incision
The goal of this clinical study is to evaluate the effectiveness and safety of a novel breast reconstruction technique combining endoscopic nipple-sparing mastectomy (E-NSM) with immediate multistage fat grafting (IMFG) in female…
- Trial name
- NCT07352137
- Testing
- endoscopic nipple-sparing mastectomy (E-NSM) with immediate implant-based reconstruction
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Guangdong Provincial Hospital of Traditional Chinese Medicine
Breast Cancer, Breast Reconstruction After Mastectomy
Study on the Cosmetic Outcome and Safety Evaluation of 3D Printed Biodegradable Biological Mesh for One-Stage Breast Reconstruction After Radical Mastectomy
Primary objective of this trial: To evaluate the clinical performance (aesthetic outcome and quality of life) and safety of a 3D-printed biodegradable biological mesh in post-mastectomy immediate breast reconstruction.
- Conditions
- Breast Cancer, Breast Reconstruction After Mastectomy, 3D-Printed Biodegradable Biological Mesh
- Trial name
- NCT07365267
- Testing
- Implantation of a silicone breast prosthesis combined with a 3D-printed biodegradable mesh
- Where
- China
- Volunteers
- 25 people
- Sponsor
- Xijing Hospital
Breast Cancer Female
PEMF and PEC Blocks in Mastectomy Reconstruction Patients
This is a prospective randomized controlled double-blind interventional study comparing the effect of pulsed-electromagnetic field device (PEMF), pectoral interfascial block (PIB), and placebo on postoperative pain control.
- Trial name
- NCT03360214
- Testing
- Bupivacaine Hydrochloride, Pulsed Electromagnetic Field (PEMF) Device, Ropivacaine Hydrochloride
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Columbia University
Lymphedema, Lymphedema of Upper Arm
Microvascular Breast Reconstruction With Lymph Node Transfer
this study aims to evaluate the outcomes of simultaneous free abdominal flap \& vascularized lymph node transfer for both breast reconstruction and postmastectomy lymphedema
- Conditions
- Lymphedema, Lymphedema of Upper Arm, Mastectomy; Lymphedema
- Trial name
- NCT04246034
- Testing
- Microvascular Breast Reconstruction with Vascularized Lymph Node Transfer
- Sponsor
- Assiut University
Breast Cancer, Radiotherapy; Complications
Hypo Versus Conventional Fractionation in Reconstructed-Breast Cancer Mastectomy Patients
This randomized Phase III study aims to show major complication rate of hypofractionation radiation therapy is not inferior, compared to conventional fractionation radiation therapy in breast cancer patients undergoing mastectomy…
- Trial name
- NCT05253170
- Testing
- Hypofractionation, Conventional Fractionation
- Volunteers
- 622 people, healthy volunteers welcome
- Sponsor
- Seoul National University Bundang Hospital
Breast Cancer
A Study of the Use of Acellular Dermal Matrix for Breast Reconstruction
The researchers are doing this study to look at the number of complications that occur immediately after prepectoral breast reconstruction when Acellular Dermal Matrix (ADM) is used compared to when ADM is not used.
- Trial name
- NCT05316324
- Testing
- Prepectoral Breast Reconstruction with Acellular Dermal Matrix (ADM), Prepectoral Breast Reconstruction without Acellular Dermal Matrix (ADM)
- Where
- 2 sites in United States
- Volunteers
- 353 people
- Sponsor
- Memorial Sloan Kettering Cancer Center