Clinical trials: Breast Reconstruction
Breast Reconstruction, Abdominal Wall Morbidity
Changes To The Abdominal Wall After DIEP Flap Breast Reconstruction
The purpose of this study was to perform an evaluation of the structural changes in the abdominal wall after harvesting a DIEP flap in breast reconstruction.
- Trial name
- NCT02563977
- Testing
- 2 year postop CT scan of the abdomen
- Where
- Norway
- Volunteers
- 14 people
- Sponsor
- Oslo University Hospital
Breast Reconstruction, Implant-Based Breast Reconstruction (IBBR)
Pre- Versus Sub-pectoral Implant-based Breast Reconstruction After Skin-sparing Mastectomy or Nipple-sparing Mastectomy OPBC-02PREPEC
This trial is to investigate whether pre-pectoral Implant-Based Breast Reconstruction (IBBR) provides better Quality of Life (QoL) with respect to long-term (24 months) physical well-being (chest) compared to sub-pectoral IBBR…
- Trial name
- OPBC-02PREPEC (NCT04293146)
- Testing
- pre-pectoral IBBR, sub-pectoral IBBR
- Where
- 22 sites in United States, Austria and 5 more
- Volunteers
- 382 people
- Sponsor
- University Hospital, Basel, Switzerland
Mammaplasty
Perioperative Care of Breast Reconstruction With Latissimus Dorsi Flap and Tissue Expander: Early Discharge Protocol in a Day Surgery Setting
The pedicled latissimus dorsi flap is a piece of tissue taken from the back that is used to reconstruct the breast after cancerous tissue is removed.
- Trial name
- NCT02791672
- Testing
- Discharge within 24 hours
- Volunteers
- 40 people
- Sponsor
- Ottawa Hospital Research Institute
Perioperative Tissue Oxygenation
Improving Tissue Oxygenation in Breast Reconstruction Surgery
Breast reconstruction is an integral part of breast cancer care. There are two main types of breast reconstruction: alloplastic (using implants), and autologous (using patient's tissue).
- Trial name
- NCT04020172
- Testing
- Dobutamine
- Where
- 2 sites in Canada
- Volunteers
- 40 people
- Sponsor
- Dr. Glenio Mizubuti (MD, PhD)
Breast Reconstruction After Mastectomy, Neurotization
Longitudinal Evaluation of Direct Neurotization Technique in Breast Reconstruction With Fully Autologous Components
This clinical trial aims to evaluate whether direct neurotization using fully autologous components during autologous breast reconstruction improves postoperative breast sensation and sensory-related quality of life in women…
- Conditions
- Breast Reconstruction After Mastectomy, Neurotization, Mastectomy and Breast Reconstruction, Peripheral Nerve Regeneration
- Trial name
- NCT07308275
- Testing
- Autologous Breast Reconstruction With Direct Neurotization, Autologous Breast Reconstruction without Neurotization
- Where
- Indonesia
- Volunteers
- 28 people
- Sponsor
- Fakultas Kedokteran Universitas Indonesia
DIEP Flap Breast Reconstruction, SIEA Flap Breast Reconstruction
Breast and Abdominal Related Morbidity of DIEP and SIEA Flaps
The Deep Inferior Epigastric Perforator flap (DIEP) is the current standard of care in breast reconstruction. The newer Superficial Inferior Epigastric Artery flap (SIEA) is felt to be an improvement as it does not damage the…
- Trial name
- NCT01469494
- Testing
- DIEP flap breast reconstruction, SIEA flap breast reconstruction
- Where
- Canada
- Volunteers
- 91 people
- Sponsor
- University of Manitoba
Breast Cancer
TAP vs QL for Postoperative Analgesia After DIEP Free Flap Breast Reconstruction
The purpose of this study is to compare the efficacy of Transversus abdominus plane (TAP) block and Quadratus Lumborum (QL) block on the quality of recovery after breast reconstruction with deep inferior epigastric perforator…
- Trial name
- NCT05301595
- Testing
- TAP block, QL Block
- Where
- Canada
- Sponsor
- Ottawa Hospital Research Institute
Breast Reconstruction, Patient Education
Educational Session To Optimize Patient's Breast Reconstruction Experience at McMaster
This pilot study uses a randomized controlled trial design to introduce an educational session for breast reconstruction patients. Participants will be randomly assigned to the (1) control group or the (2) experimental group.
- Trial name
- RESTORE (NCT03743753)
- Testing
- Experimental
- Where
- 2 sites in Canada
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- McMaster 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 Cancer, Surgical Site Infection
NPWT for Abdominal Incisions in DIEP Reconstructions: A RCT
The current study is a single center randomized control trial that will examine the effect of closed incision negative pressure wound therapy (ciNPT) versus conventional dressing on abdominal incision in a deep inferior…
- Conditions
- Breast Cancer, Surgical Site Infection, Wound Dehiscence
- Trial name
- NPWTinDIEP (NCT05338281)
- Testing
- Negative Pressure Wound Therapy
- Where
- Canada
- Sponsor
- Western University, Canada
Breast Reconstruction, Perfusion; Complications
Assessment of Topical Minoxidil on Intraoperative Flap Perfusion and Cutaneous Flap Viability in Breast Recon
The purpose of the study is to determine whether pharmacologic delay using minoxidil in patients undergoing bilateral risk reducing mastectomy with reconstruction could achieve improvement in flap perfusion and flap viability at…
- Conditions
- Breast Reconstruction, Perfusion; Complications, High Risk for Breast Cancer, Genetic Predisposition
- Trial name
- NCT07264790
- Testing
- Minoxidil, Hair mousse
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Duke University
Breast Neoplasms, Germline BRCA1 Gene Mutation
Prospective Study of MAstectomy With Reconstruction Including Robot Endoscopic Surgery
Robotic mastectomy and immediate reconstruction have been introduced in 2015. However, since robotic mastectomy is the latest surgical technique, there is a lack of studies prospectively comparing conventional mastectomy and…
- Conditions
- Breast Neoplasms, Germline BRCA1 Gene Mutation, Germline BRCA2 Gene Mutation, Benign Breast Disease
- Trial name
- MARRES (NCT04585074)
- Testing
- Robotic or endoscopic nipple sparing mastectomy, Conventional mastectomy (including nipple sparing mastectomy, skin sparing mastectomy)
- Where
- 18 sites in South Korea
- Volunteers
- 2,000 people
- Sponsor
- Severance Hospital
Respiratory Function, Breast Reconstruction
The Effect of Breast Reconstruction Surgery Using Tissue Expanders on Respiratory Functions
This study evaluates the effect of breast reconstruction surgery on respiratory functions. 45 patients elected for unilateral or bilateral breast reconstruction surgery will go through respiratory function examinations a month…
- Trial name
- NCT02491762
- Testing
- respiratory function tests
- Where
- Israel
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Yaron Har-Shai
Breast Cancer
Functional MRI Study Reconstructed Breasts
Rationale: To study the effects of mastectomy and autologous breast reconstruction on the sensation of the (reconstructed) breast, not only the peripheral reinnervation of the breast should be studied, but also the changes that…
- Trial name
- NCT03702556
- Testing
- MRI scan
- Where
- Netherlands
- Volunteers
- 30 people
- Sponsor
- Maastricht University Medical Center
Breast Reconstruction After Mastectomy
Thermal Preconditioning in Mastectomy Patients With Immediate Breast Reduction
The purpose of this research study is to understand patient experiences and the feasibility of using a breast heat preconditioning device (Plexaa BLOOM43), designed to improve postoperative outcomes when used prior to mastectomy…
- Trial name
- NCT07516483
- Testing
- 1 Cycle Thermal Preconditioning, 3 Cycles Thermal Preconditioning, No Intervention
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Wake Forest University Health Sciences
Postoperative Pain
Observational Study to Assess Long-Term Follow-Up of Breast Augmentation Subjects
A history and physical focused on clinical sequelae of breast implant rupture was completed by patients to assess long-term clinical sequelae of SKY0402 and its relation to the silicon shell.
- Trial name
- NCT01076686
- Testing
- Questionnaire and Physical Exam
- Volunteers
- 94 people
- Sponsor
- Pacira Pharmaceuticals, Inc
Breast Cancer
A Study of a Decision Tool for People Considering Breast Reconstruction Surgery
The purpose of this study is to find out whether it is practical (feasible) to do a larger study looking at the effectiveness of the Breast Reconstruction Decision Aid Tool (RECONJOINT) for breast reconstruction surgery.
- Trial name
- NCT07335354
- Testing
- RECONJOINT
- Where
- 9 sites in United States
- Volunteers
- 131 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Breast Disease, Breast Cancer
Comparison of Patient Reported Outcome Measures Using the BREAST-Q Questionnaire in Patients Undergoing Pre Versus Sub-pectoral Implant Based Immediate Breast Reconstruction.
The PROM Q study aims to compare patient reported outcome measures (PROMs) in patients undergoing mastectomy and immediate implant based breast reconstruction (IBR).
- Conditions
- Breast Disease, Breast Cancer, Patient Satisfaction, Surgery
- Trial name
- PROM-Q (NCT04842240)
- Testing
- Pre- or sub-pectoral implant based immediate breast reconstruction
- Where
- United Kingdom
- Volunteers
- 60 people
- Sponsor
- The Leeds Teaching Hospitals NHS Trust
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
Primary Radiotherapy And DIEP flAp Reconstruction Trial
Many women with breast cancer now live for decades after their breast cancer treatment. In view of this, modern breast reconstruction surgery after mastectomy for breast cancer aims to reproduce as natural a breast shape as…
- Trial name
- PRADA (NCT02771938)
- Testing
- Radiotherapy before surgery
- Where
- United Kingdom
- Volunteers
- 33 people
- Sponsor
- Royal Marsden NHS Foundation Trust