Clinical trials: Breast Reconstruction
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 Female
External Vacuum Expansion: Evaluation in Breast Reconstructive Surgery Evaluation in Breast Reconstructive Surgery
This multicentre randomized controlled trial aims to evaluate a new breast reconstruction technique- autologous fat transfer (AFT).
- Trial name
- EVE (NCT05003635)
- Testing
- EVEBRA device
- Where
- 3 sites in Netherlands
- Volunteers
- 90 people
- Sponsor
- Maastricht University Medical Center
Postoperative Pain, Chronic Pain
A Clinical Trial of a Psycho-educational Intervention to Improve Pain Management After Day Surgery
Evidence indicates that postoperative pain after day surgery is inadequately controlled. Patients have different experiences and knowledge about how to deal with pain, and the need for information and clarification may vary.
- Trial name
- NCT01595035
- Testing
- psychoeducational
- Where
- Norway
- Volunteers
- 200 people
- Sponsor
- Oslo Metropolitan University
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 Early Stage Breast Cancer (Stage 1-3)
The Application of "HUAXI Hole 1" in Reverse-sequence Endoscopic Nipple-sparing Mastectomy With Direct-to-implant Breast Reconstruction
This study is a multicenter, open-label, randomized controlled trial. It will prospectively compare outcomes between patients undergoing reverse-sequence endoscopic NSM (R-E-NSM) with direct-to-implant breast reconstruction…
- Trial name
- HUAXI-h-01 (NCT06995118)
- Testing
- HUAXI hole 1
- Where
- 20 sites in China
- Volunteers
- 337 people
- Sponsor
- Du Zhenggui
Breast Reconstruction, Breast Augmentation
Mentor MemoryGel Post-Approval Study
In November 2006, U.S. Food and Drug Administration (FDA) approved Mentor's MemoryGel silicone gel-filled breast implants for use in women who are undergoing primary or revisional breast augmentation and primary or revisional…
- Conditions
- Breast Reconstruction, Breast Augmentation, Breast Revision
- Trial name
- MGPAS (NCT00756652)
- Testing
- Mentor Silicone Gel-Filled Breast Implants, Saline Breast Implants
- Volunteers
- 42,491 people, healthy volunteers welcome
- Sponsor
- Mentor Worldwide, LLC
Breast Reconstruction, Breast Reconstruction Following Mastectomy
Post-market Prospective Clinical Study of Nagor Perle Mammary Implants
Patients can undergo breast implant surgery for multiple reasons; cosmetic and reconstructive being the primary indications. In order to confidently state safety and due to strict regulation on medical devices it is important to…
- Conditions
- Breast Reconstruction, Breast Reconstruction Following Mastectomy, Breast Revision, Breast Augmentation
- Trial name
- PERLE10PMCF (NCT06013514)
- Testing
- PERLE Sterile Smooth Opaque gel filled mammary implants
- Where
- United Kingdom
- Volunteers
- 60 people
- Sponsor
- GCA (Eurosilicone)
Breast Cancer, Surgery--Complications
Surgical and Patient Reported Outcomes of Robotic Nipple-Sparing Mastectomy
Nipple-sparing mastectomy (NSM) with immediate reconstruction is one of the standard of care surgical treatments of breast cancer (BC) and is used for risk reduction in patients with a high risk for BC.
- Conditions
- Breast Cancer, Surgery--Complications, Genetic Predisposition to Disease, Surgery
- Trial name
- RNSM (NCT04151368)
- Testing
- Robotic Nipple-Sparing Mastectomy (RNSM)
- Where
- Canada
- Volunteers
- 30 people
- Sponsor
- University Health Network, Toronto
Breast Cancer
Evaluation of Half-Dose Molecular Breast Imaging With Wide Beam Reconstruction Processing
The primary objective of this work is to determine if half-dose Molecular Breast Imaging (MBI) performed with 4 mCi Tc-99m sestamibi with or without Wide Beam Reconstruction applied can achieve image quality and diagnostic…
- Trial name
- Split-Dose (NCT01653964)
- Testing
- Molecular breast imaging
- Where
- United States
- Volunteers
- 83 people, healthy volunteers welcome
- Sponsor
- Mayo Clinic
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
Immediate Breast Reconstruction With Free Greater Omentum
Luminal subtype breast cancer, accounting for 70 to 80% of all breast cancers, has been reported to be associated with good prognosis.
- Trial name
- NCT03370250
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Xijing Hospital
Breast Cancer
Selective Intraoperative Administration of Local Anesthesia in Breast Reconstruction
Subjects are being asked to participate in this study because they will be undergoing unilateral (one) or bilateral (two) mastectomy surgery with immediate reconstruction involving insertion of a tissue expander.
- Trial name
- NCT02525718
- Testing
- Saline, 0.25 % bupivacaine (2.5 mg/ml) w/ 1:100,000 epinephrine & 4 mg dexamethasone
- Where
- United States
- Volunteers
- 47 people
- Sponsor
- Northwestern University
Complications, Postoperative/Perioperative, Quality of Life
Complications and Long-term Satisfaction in Autologous vs. Implant-Based Breast Reconstruction
Current literature on complications and health-related quality of life in autologous and alloplastic breast reconstruction is inconclusive.
- Conditions
- Complications, Postoperative/Perioperative, Quality of Life, Satisfaction, Patient
- Trial name
- NCT06295042
- Testing
- BREAST-Q Questionnaire
- Where
- Austria
- Volunteers
- 162 people, healthy volunteers welcome
- Sponsor
- Medical University of Graz
Breast Cancer
Opioid Free Versus Opioid Based Anaesthesia for Free Flap Reconstruction Surgery of the Breast: A Phase III Multicentric Randomized Controlled Study.
This study will compare morphine consumption during the first 48 hours postoperatively between the OFA group and the CA control group.
- Trial name
- OFOBA (NCT05439005)
- Testing
- Dexmedetomidine
- Where
- 3 sites in France
- Volunteers
- 158 people
- Sponsor
- Institut Curie
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
Macromastia
Study of Prineo (Dermabond Protape) Versus Sutures in Breast Procedures
This is a prospective, controlled, randomized, multi-center clinical study of up to 80 patients with full thickness surgical incisions associated with bi-lateral breast procedures.
- Trial name
- NCT00558246
- Testing
- Dermabond Protape (Prineo), Suture
- Where
- 5 sites in Belgium, Germany and 2 more
- Volunteers
- 79 people
- Sponsor
- Ethicon, Inc.
Deep Inferior Epigastric Artery Perforator Flap Breast Reconstruction
The Effect of Volatile Anesthesia and Total Intravenous Anesthesia on Shedding of the Endothelial Glycocalyx in Patients Undergoing Mastectomy and Breast Reconstruction Using Deep Inferior Epigastric Artery Perforator Free Flap
The aim of this study was to investigate the effects of total intravenous and inhalation anesthesia on the damage of endothelial glucocorticoids by comparing the concentration of syndecan-1 in patients undergoing mastectomy and…
- Trial name
- NCT05136508
- Testing
- Propofol, Sevoflurane
- Where
- South Korea
- Volunteers
- 50 people
- Sponsor
- Yonsei University
Breast Cancer, Ductal Carcinoma
Nipple-Areola Complex (NAC) Irradiation After Nipple-Sparing Mastectomy and Reconstruction
The purpose of this research study is to see if a participant's nipple and areola can be safely preserved by adding radiation to these areas after a nipple-sparing mastectomy and immediate breast reconstruction.
- Trial name
- NCT01208974
- Testing
- Nipple-Sparing Mastectomy, Breast Reconstruction, Axillary Surgery
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- University of Miami
Breast Cancer Female
Psychological Effects of Implant Loss
Previous quality of life studies have suggested that long term satisfaction with breast reconstruction may be affected by postoperative complications.
- Trial name
- NCT04503018
- Where
- Sweden
- Volunteers
- 150 people
- Sponsor
- Vastra Gotaland Region
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