Clinical trials: Post-mastectomy Breast Reconstruction
Breast Cancer
A Nationwide Multicenter, Single-arm, Retrospective Study of Delayed Endoscopic DTI-BR After Simple Mastectomy
This study is a nationwide multicenter, single-arm, retrospective study. The study aims to conduct a detailed analysis of operation-related parameters, aesthetic outcomes (e.g., BREAST-Q scores and Harris scores), and safety…
- Trial name
- DEDTI-BR (NCT07257003)
- Testing
- delayed endoscopic direct-to-implant breast reconstruction via axillary approach after simple mastectomy
- Where
- China
- Volunteers
- 150 people
- Sponsor
- Du Zhenggui
Pain, Postoperative, Breast Cancer
Speeding Recovery From Pain and Opioid Use
Surgical treatment of breast cancer is associated with significant disability, and pain is often reported as a primary cause for declines in the ability to perform activities of daily living.
- Conditions
- Pain, Postoperative, Breast Cancer, Opioid Use, Surgery
- Trial name
- NCT03388814
- Testing
- Local infiltration of bupivacaine, Pectoralis Nerve block
- Sponsor
- Wake Forest University Health Sciences
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
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
Post-op Outcomes of Enhanced Energy Delivery Dissection for Mastectomy With Immediate Breast Reconstruction
Principal Investigator: Sheldon Feldman, MD Co-Principal Investigator: Mohamad Sebai, MD Department of Surgery, Montefiore Medical Center - Einstein College of Medicine Title Pilot Study: Post-operative outcomes of enhanced…
- Trial name
- NCT03627442
- Testing
- Mastectomy with PhotonBlade, Mastectomy with Bovie
- Volunteers
- 15 people
- Sponsor
- Invuity, Inc.
Breast Cancer
A Comparative Study of Delayed Endoscopic DTI and Latissimus Dorsi ±Impalnt Reconstruction Post-Mastectomy
Breast cancer is the most common malignancy in women. In 2022, China saw about 357,200 new cases and 75,000 deaths, accounting for 15.59% and 7.94% of all new cancer cases and cancer-related deaths, respectively.
- Trial name
- DELTI (NCT07757074)
- Testing
- Surgery options
- Where
- China
- Volunteers
- 268 people
- Sponsor
- Du Zhenggui
Breast Carcinoma
Hypofractionated Post Mastectomy Radiation With Two-Stage Expander/Implant Reconstruction
Hypofractionated radiotherapy could provide more convenient treatment and had similar toxicities.However,reports of hypofractionated radiotherapy with two-stage expander/implant reconstruction are rare,Some studies have shown…
- Trial name
- NCT05045287
- Testing
- hypofractionated radiotherapy
- Where
- China
- Volunteers
- 57 people
- Sponsor
- Chinese Academy of Medical Sciences
Breast Cancer, Acquired Absence of Breast
Long-term Evaluation of Quality of Life and Aesthetic Outcomes After Autologous Breast Reconstruction Using the Profunda Artery Perforator (PAP) Flap
Breast reconstruction using autologous tissue is an important option for women undergoing mastectomy for breast cancer. The profunda artery perforator (PAP) flap is a reliable alternative when abdominal tissue is unavailable or…
- Conditions
- Breast Cancer, Acquired Absence of Breast, Autologous Breast Reconstruction
- Trial name
- QUALIPAP (NCT07728565)
- Where
- France
- Volunteers
- 264 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Breast Cancer, Mastectomy; Lymphedema
Examining the Cosmetic Results, Quality of Life and Patient Satisfaction Achieved With Skin Reducing Nipple Sparing Mastectomy and Implant Based Breast Reconstruction, and Comparing it to Classic Skin- Sparing Mastectomy and Implant- Based Breast Reconstructive Surgeries
This is a response-adaptive (RAR) prospective randomized study with a long-term follow-up and the aim of this clinical study is to measure with qualitative and quantitative indicators the changes in cosmetic results, quality of…
- Conditions
- Breast Cancer, Mastectomy; Lymphedema, Quality of Life, Patient Satisfaction
- Trial name
- NCT04345081
- Testing
- Skin Reducing Nipple Sparing Mastectomy and Implant Based Breast Reconstruction, Skin- Sparing Mastectomy and Implant- Based Breast Reconstructive Surgery
- Where
- Hungary
- Volunteers
- 110 people
- Sponsor
- National Institute of Oncology, Hungary
Breast Cancer
Bupivacaine vs Placebo for Unilateral Mastectomy Surgical Site Post-operative Pain Control
The purpose of this study is to compare using FDA-approved bupivacaine (a numbing medicine), along with the usual medications for post-operative pain control to using the usual medications for postoperative pain control alone.
- Trial name
- NCT03351348
- Testing
- Bupivacaine, patient-reported pain scores, saline
- Where
- 7 sites in United States
- Volunteers
- 165 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Post-mastectomy Breast Reconstruction
Long Term Function Outcomes and Pain in Implant-based Post-mastectomy Breast Reconstruction
The objective of this proposal is to broadly assess patient physical functioning following breast reconstruction.
- Trial name
- NCT04477538
- Testing
- Post-mastectomy breast reconstruction physical well-being survey
- Where
- United States
- Volunteers
- 240 people
- Sponsor
- Washington University School of Medicine
Postoperative Complications, Recurrence
Surgical and Oncologic Outcomes After Robotic Nipple Sparing Mastectomy and Immediate Reconstruction
Robotic mastectomy with immediate reconstruction was introduced by Toesca et al. in 2015. Since then, several studies have reported the safety and feasibility of robotic nipple-sparing mastectomy with immediate reconstruction.
- Conditions
- Postoperative Complications, Recurrence, Breast Neoplasms, Breast Cancer
- Trial name
- SORI (NCT04108117)
- Testing
- Robotic nipple sparing mastectomy
- Where
- South Korea
- Volunteers
- 659 people, healthy volunteers welcome
- Sponsor
- Severance Hospital
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 Cancer
The Combination of PECS II Block and Parasternal Block for Radical Mastectomy
The combination of PECS II and parasternal Block provides analgesia after radical mastectomy
- Trial name
- NCT03754816
- Testing
- PECS II and parasternal block, Levobupivacaine
- Where
- Italy
- Volunteers
- 65 people
- Sponsor
- San Salvatore Hospital of L'Aquila
Breast Cancer, Breast Reconstruction
Autologous Fat Grafting for Total Breast Reconstruction in Irradiated Breast Cancer Patients
The goal of this clinical trial is to learn whether autologous fat transfer (AFT) is as effective and safe as Deep Inferior Epigastric Perforator (DIEP) flap breast reconstruction in irradiated breast cancer patients following…
- Conditions
- Breast Cancer, Breast Reconstruction, Breast Reconstruction After Mastectomy, Breast Cancer Radiation
- Trial name
- AFT-R (NCT07641985)
- Testing
- Autologous fat transfer, Deep inferior epigastric perforator flap
- Where
- Netherlands
- Volunteers
- 280 people
- Sponsor
- Maastricht University Medical Center
Breast Cancer, Gynecologic Cancer
Mobile App Postoperative Home Monitoring After Enhanced Recovery Oncologic Surgery
This study will assess whether the implementation of a combination of ERAS (Enhanced Recovery After Surgery) protocols and postoperative followup via a smartphone app can offer 1) improved patient satisfaction, 2) virtual patient…
- Trial name
- ERAS-OncoRe (NCT03456167)
- Testing
- RecoverWell mobile app for follow-up care
- Where
- Canada
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Alberta Health Services, Calgary
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
Nonmalignant Breast Conditions, Breast Cancer
Trial of Drain Antisepsis After Tissue Expander Breast Reconstruction
Surgical site infection (SSI) after breast and axillary surgery occurs more often than for other clean surgical procedures. Infection in the setting of a tissue expander can be devastating and can lead to early implant loss and…
- Trial name
- NCT01286168
- Testing
- Sodium hypochlorite (Dakin's Solution), Chlorhexidine gluconate disk, Control
- Where
- 2 sites in United States
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- Mayo Clinic
Post-Mastectomy Chronic Pain Syndrome (Disorder)
Cryoablation for Post Mastectomy Pain Syndrome
This is a prospective, randomized, parallel-group, treatment control trial with cross-over options performed at four sites. The purpose of this study is to assess the efficacy and safety of cryoablation therapy for the treatment…
- Trial name
- NCT03293940
- Testing
- Cryoablation, Therapeutic Peripheral Nerve Block (tPNB) Injection
- Where
- 4 sites in United States
- Volunteers
- 35 people
- Sponsor
- Emory University
Breast Cancer
Patient Preferences for Breast Reconstruction After Mastectomy
Deciding whether or not to have breast reconstruction after mastectomy is highly challenging for many patients. This study will examine patients' decisions about reconstruction and the effects of reconstruction on quality of life…
- Trial name
- NCT01488357
- Where
- United States
- Volunteers
- 145 people
- Sponsor
- UNC Lineberger Comprehensive Cancer Center