Clinical trials: Breast Implant; Complications
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
Surgical Site Infection, Capsular Contracture Associated With Breast Implant
Postoperative Antibiotics Following Primary and Secondary Breast Augmentation
Postoperative antibiotics are routinely used for implant-based breast augmentation at the investigators' institution. From 2017-2019, the investigators' institution has conducted approximately 270 primary and secondary breast…
- Conditions
- Surgical Site Infection, Capsular Contracture Associated With Breast Implant, Antibiotic Resistant Infection, Antibiotic Side Effect
- Trial name
- NCT04834310
- Testing
- Cefazolin, Cephalexin
- Volunteers
- healthy volunteers welcome
- Sponsor
- University of California, Los Angeles
Colorectal Neoplasms, Colorectal Cancer
Personalized Patient Derived Xenograft (pPDX) Modeling to Test Drug Response in Matching Host
By obtaining clinical specimens from participants with triple negative breast cancer (TNBC), colorectal cancer (CRC), high grade serous ovarian cancer (HGSOC), and other select tumor types to establish and profile as freshly…
- Conditions
- Colorectal Neoplasms, Colorectal Cancer, Breast Cancer, Breast Neoplasms
- Trial name
- REFLECT (NCT02732860)
- Testing
- Molecular Profiling & In Vivo drug testing in pPDX and organoid cultures
- Where
- Canada
- Volunteers
- 120 people
- Sponsor
- University Health Network, Toronto
Breast Implant; Complications
Breast Reconstruction
Complications following postmastectomy breast reconstruction can compromise surgical outcomes and lead to significant morbidity.
- Trial name
- NCT06332937
- Testing
- postmastectomy breast reconstruction
- Where
- South Korea
- Volunteers
- 5,000 people
- Sponsor
- Seoul National University Hospital
Breast Implant; Complications
Split Chest Breast Neurotization
Several members of the scientific community have suggested that breast neurotization can help return nipple sensation to patients undergoing implant-based breast reconstruction.
- Trial name
- NCT05757778
- Testing
- Sensory Nerve Coaptation
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- NYU Langone Health
Postoperative Pain, Postoperative Nausea and Vomiting
Pre-pectoral AlloDerm® to Reinforce Tissues in Tissue Expander Breast Reconstruction
Primary Objective: To describe postoperative static pain scores on the Pain Visual Analog Scale at Day 1 in a population of women undergoing bilateral mastectomy followed by immediate, bilateral pre-pectoral tissue expander…
- Conditions
- Postoperative Pain, Postoperative Nausea and Vomiting, Quality of Life, Breast Cancer
- Trial name
- NCT03195322
- Testing
- Pre-pectoral Tissue Expander
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Johns Hopkins University
Bacterial Infection, Anti-infective Agents
Postoperative Antibiotic Requirements Following Immediate Breast Reconstruction
Antibiotics are used routinely in postoperative tissue expander based breast reconstruction (TE) and autologous flap (AF) breast reconstruction procedures.
- Conditions
- Bacterial Infection, Anti-infective Agents, Breast Implantation
- Trial name
- NCT01244698
- Testing
- Cefadroxil discontinued early, Cefadroxil until drain removal
- Where
- United States
- Volunteers
- 132 people, healthy volunteers welcome
- Sponsor
- Stony Brook University
Breast Implant-Associated Anaplastic Large Cell Lymphoma, Capsular Contracture, Implant
Breast-implant ASsocIated anaplastIc Large Cell Lymphoma and CApsular Contracture
BASILICA is a UK NIHR Biomedical Research Centre funded study recruiting patients at The Royal Marsden NHS Foundation Trust. The study aims to obtain blood and tissue samples from patients with breast implant-associated…
- Conditions
- Breast Implant-Associated Anaplastic Large Cell Lymphoma, Capsular Contracture, Implant, Breast Implant; Complications
- Trial name
- BASILICA (NCT05017337)
- Where
- 2 sites in United Kingdom
- Volunteers
- 100 people
- Sponsor
- Royal Marsden NHS Foundation Trust
Capsular Contracture, Implant
Ultrasound Guided Treatment of Steroids for Capsular Contracture in Patients With Reconstructed/Augmented Breast
Ultrasound guided treatment of steroids for capsular contracture in patients with reconstructed/augmented breast
- Trial name
- NCT03171974
- Testing
- Dexamethasone, US
- Where
- Israel
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Rabin Medical Center
Rare Disorders, Undiagnosed Disorders
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
The Coordination of Rare Diseases at Sanford (CoRDS) is an international patient registry that serves as a centralized resource for rare disease research.
- Conditions
- Rare Disorders, Undiagnosed Disorders, Disorders of Unknown Prevalence, Cornelia De Lange Syndrome
- Trial name
- CoRDS (NCT01793168)
- Where
- United States
- Volunteers
- 20,000 people
- Sponsor
- Sanford Health
Breast Implant; Complications
Multicenter Post-marketing Survey of SEBBIN Group Silicone Gel-filled Breast Implants
The aim of the study is to allow Groupe SEBBIN to communicate to competent authorities and to the scientific community data relative to the safety and effectiveness of SEBBIN silicone gel-filled breast implants.
- Trial name
- IM02 (NCT04968457)
- Volunteers
- 908 people, healthy volunteers welcome
- Sponsor
- Groupe SEBBIN
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 Cancer, Breast Implant; Complications, Infection or Inflammation
Randomized Feasibility Trial for Mesh in Pre-Pectoral Reconstruction
Surgical mesh products, particularly acellular dermal matrices (ADM), are now used by the majority of plastic surgeons to assist with the nearly 100,000 prosthetic breast reconstruction procedures in the United States, despite…
- Trial name
- NCT05190978
- Testing
- Acellular Dermal Matrix, Reconstruction without ADM
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- University of California, Los Angeles
Breast Neoplasms
Clinical Outcomes and Complications in Two-stage Breast Reconstruction Using Microtextured and Nanotextured Expanders
This retrospective observational study evaluates clinical outcomes and complication rates in women who underwent two-staged implant-based breast reconstruction using tissue expanders and implants following mastectomy for breast…
- Trial name
- RA-IBBR-NvsM (NCT07442838)
- Where
- Slovakia
- Volunteers
- 88 people
- Sponsor
- Comenius University
Breast Implant; Complications, Breast Implantation; Methods, Safety and Performance
Safety and Performance of Motiva® Sizers
The Motiva® Sizer clinical study is a four-year, multicenter, post-marketing, and cohort study, designed to confirm the safety and performance of Motiva® Sizer in breast augmentation or reconstruction procedures.
- Conditions
- Breast Implant; Complications, Breast Implantation; Methods, Safety and Performance, Mammaplasty, Breast Reconstruction
- Trial name
- NCT06274736
- Testing
- Motiva Sizer
- Where
- Costa Rica
- Volunteers
- 133 people, healthy volunteers welcome
- Sponsor
- Establishment Labs
Breast Implant Complication, Breast Implant Shell Defect
Prospective Longitudinal Cohort Study of Implant Age, Pocket Plane, Incision, Surface Texture, and Volume as Predictors of Breast Implant Shell Fissure
This prospective implant-surveillance cohort will evaluate predictors of breast implant shell fissure. Women with aesthetic implants without baseline fissure or rupture will undergo annual clinical and imaging assessment for up…
- Trial name
- NCT07810257
- Testing
- Breast Implant Exposure, Structured Implant Shell Imaging
- Where
- Colombia
- Volunteers
- 3,000 people
- Sponsor
- Research Inc
Systemic Symptoms, Breast Implant Illness
Prospective Controlled Cohort Study of the Incidence, Trajectory, and Clinical Correlates of Persistent Systemic Symptoms in Women With and Without Silicone Breast Implants
This prospective controlled cohort will enroll women before primary aesthetic breast surgery. Women receiving silicone implants will be compared with women undergoing nonimplant mastopexy or reduction.
- Conditions
- Systemic Symptoms, Breast Implant Illness, Breast Implant Complications
- Trial name
- NCT07810803
- Testing
- Silicone Breast Implant Exposure, Standardized Systemic Symptom and Psychosocial Assessment
- Where
- Colombia
- Volunteers
- 3,000 people
- Sponsor
- Research Inc
Pain
Comparison of Two Methods in Pain Caused by Orogastric Tube Placement in Preterm Newborns
Aim : This study will be conducted to determine the effect of breast milk and knitted octopus in reducing pain caused by routine orogastric tube insertion in preterm newborns.
- Trial name
- NCT06438731
- Testing
- BREAST MILK, KNITTED OCTOPUS
- Where
- Turkey (Türkiye)
- Volunteers
- 66 people
- Sponsor
- Pamukkale University
Breast Neoplasm Female, Breast Reconstruction
Axillary Versus Primary Breast Approach for Second-stage Breast Reconstruction
The goal of this clinical trial is to compare the safety of axillary or primary breast approach for second-stage operation in expander-implant breast reconstruction for breast cancer patients.
- Conditions
- Breast Neoplasm Female, Breast Reconstruction, Wound Complication
- Trial name
- AvBSR (NCT05600153)
- Testing
- implant exchange operation
- Where
- China
- Volunteers
- 136 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
Post-operative Pain
A Prospective Trial to Reduce Post-Operative Pain in Implant Based Breast Reconstruction
The investigators hypothesize that in mastectomy patients with breast reconstruction, the addition of bupivacaine and botulinum toxin (BT) will result in better pain control in the acute and chronic setting, compared to…
- Trial name
- NCT02044302
- Testing
- Bupivacaine, Botulinum Toxins, Analgesics
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Yale University