Clinical trials: Implant Breast Reconstruction
Breast Cancer
SurgiMend in Two-stage Implant-based Breast Reconstruction in Patients With Pre-Mastectomy Radiotherapy
This is a prospective clinical study comparing two-stage breast reconstruction following mastectomy with and without the use of SurgiMend® PRS fetal bovine collagen matrix in patients with pre-mastectomy radiation therapy.
- Trial name
- NCT01959867
- Testing
- SurgiMend® PRS, No Intervention
- Sponsor
- Integra LifeSciences Corporation
Mastectomy; Lymphedema, Breast Cancer
Examining and Comparing the Temporal Changes and Results of Cosmetic, Quality of Life and Patient Satisfaction Achieved With Immediate and Delayed-immediate Implant-based Breast Reconstruction Procedures and Contralateral Symmetrization Techniques
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
- Mastectomy; Lymphedema, Breast Cancer, Quality of Life
- Trial name
- NCT04356235
- Testing
- A: expander-silicone implant exchange and contralateral symmetrization with mastopexy and if needed with volume reduction, B: expander-silicone implant exchange with contralateral symmetrization with mastopexy and Ultrapro sling, C: expander-silicone implant exchange and contralateral symmetrization with mastopexy and silicone implant augmentation
- Where
- Hungary
- Volunteers
- 528 people, healthy volunteers welcome
- Sponsor
- National Institute of Oncology, Hungary
Breast Cancer, DCIS
Robotic Nipple Sparing Mastectomy with Immediate Reconstruction
Aim of this trial is to verify whether the patients' quality of life can be improved by a less invasive surgical procedure and whether the use of robotic technique for nipple-sparing mastectomy associated to prepectoral direct…
- Conditions
- Breast Cancer, DCIS, BRCA Mutation
- Trial name
- NCT06860217
- Testing
- Robotic Nipple-Sparing Mastectomy
- Where
- Italy
- Volunteers
- 24 people
- Sponsor
- European Institute of Oncology
Implant Complication, Implant Infection
Local Antibiotics for Breast Implants
The BREAST-AB Trial is a multi-center, randomized, double blind, placebo-controlled trial investigating the efficacy of local application of gentamicin, vancomycin and cefazolin in decreasing all-cause implant explantation after…
- Conditions
- Implant Complication, Implant Infection, Implant Site Infection, Implant Capsular Contracture
- Trial name
- BREAST-AB (NCT04731025)
- Testing
- Gentamicin, Cefazolin and Vancomycin
- Where
- 8 sites in Denmark
- Volunteers
- 1,003 people, healthy volunteers welcome
- Sponsor
- Mikkel Herly
Mastectomy and Breast Reconstruction, Tissue Expander Based Breast Reconstruction
Comparison of Mastectomy Expander Trial
Expanders are used outside their intended use, due to two following facts: It is possible that expander implantation exceed the "approved" duration of 6 months (maximal 10 months).
- Conditions
- Mastectomy and Breast Reconstruction, Tissue Expander Based Breast Reconstruction, Adjuvant Radiotherapy, Long Term Outcome
- Trial name
- COMMET (NCT07434648)
- Testing
- intervention (unilateral/bilateral), scheduled for (NSME/SSME), indication (breast cancer diagnosis (malignancy) with neoadjuvant chemotherapy or DCIS diagnosis without neoadjuvant chemotherapy
- Volunteers
- 80 people
- Sponsor
- Medical University Innsbruck
Breast Cancer, Capsular Contracture Associated With Breast Implant
Predictive Toxicity Test Linked to Radiotherapy After Mastectomy and Immediate Implant Reconstruction
This study evaluates the capacity of the NovaGray RILA Breast® test to predict the toxicity linked to radiotherapy and the impact of implant breast reconstruction.
- Trial name
- PRETORIA (NCT04342546)
- Testing
- NovaGray RILA Breast® test
- Where
- 9 sites in France
- Volunteers
- 250 people
- Sponsor
- Institut du Cancer de Montpellier - Val d'Aurelle
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
Mastectomy and Breast Reconstruction
Efficacy Study of Single Stage Breast Reconstruction in Female Participants With Mastectomy
The purpose of this study was to compare the efficacy of immediate single-stage post-mastectomy breast reconstruction with Strattice Reconstructive Tissue Matrix (Strattice) as compared to immediate two-stage post-mastectomy…
- Trial name
- ESSBR (NCT01910298)
- Testing
- Breast Reconstruction, Direct to Implant (DTI) with Strattice™, Two Stage Breast Reconstruction
- Where
- 18 sites in France, Germany and 1 more
- Volunteers
- 131 people
- Sponsor
- LifeCell
Breast Cancer
One-stage Breast Reconstruction Using Dermal Matrix/Implant Versus Two-stage Expander/Implant Procedure
Currently the two-stage tissue expander/implant (TE/I) technique is the standard breast reconstructive option for breast cancer patients selected for immediate, skin-sparing mastectomy.
- Trial name
- AllodermRCT (NCT00956384)
- Testing
- One-stage dermal matrix/implant procedure, Two-stage tissue expander/implant procedure
- Where
- 4 sites in Canada
- Volunteers
- 198 people, healthy volunteers welcome
- Sponsor
- University Health Network, Toronto
Breast Cancer
Drain Removal on Postoperative Safety and Patient Satisfaction in R-E-NSM With Prepectoral DIBR
Breast cancer is a malignant tumor that seriously threatens the health of women, with an increasing incidence rate. The current main treatment methods include multidisciplinary diagnosis and treatment such as surgery…
- Trial name
- DRAIN (NCT07237828)
- Testing
- Drain Removal Timing After Endoscopic Breast Reconstruction Surgery
- Where
- China
- Volunteers
- 379 people
- Sponsor
- Du Zhenggui
Breast Cancer
Breast Reconstruction With Acellular Dermal Matrix in the Setting of Breast Cancer Treatment
To evaluate breast reconstruction with implants using biological mesh (Strattice™) in the setting of breast cancer treatment.
- Trial name
- NCT02061527
- Testing
- Reconstruction with ADM., Skin or nipple sparing mastectomy, Reconstruction with implant
- Where
- 5 sites in Sweden, United Kingdom
- Volunteers
- 135 people
- Sponsor
- Karolinska University Hospital
Breast Neoplasms
Cold Dissection Versus Electrocautery Dissection in Endoscopic Nipple-Sparing Mastectomy and Immediate Implant-Based Reconstruction: A Randomized Controlled Trial
The purpose of this study is to analyze whether cold dissection can decrease the rate of ischemia necrosis and other complications and then increase the aesthetic outcomes compared to electrocautery.
- Trial name
- NCT06024187
- Testing
- Cold dissection, Electrocautery Dissection
- Where
- China
- Volunteers
- 566 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
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
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 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
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 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
Breast Cancer Female
Pain and Functional Recovery After Mastectomy and IBR by Implant: Prepectoral Versus Subpectoral Technique
This is a prospective, single-center, non-randomized study of immediate breast reconstruction (IBR) using a pre- or retro-pectoral technique in patients with breast cancer who have undergone total mastectomy.
- Trial name
- DREAM-RMI (NCT05527769)
- Testing
- mastectomy + immediate breast reconstruction
- Where
- France
- Volunteers
- 27 people
- Sponsor
- Institut Cancerologie de l'Ouest
Breast Implant; Complications, Breast Implant Protrusion
Standard Silicone-based vs. B-Lite® Light Weight Breast Implant After Total Mastectomy and Radiotherapy for Breast Cancer
Reconstructive surgery with breast implants after total mastectomy for breast cancer is invariably related to several possible complications, such as atrophy of surrounding tissues, skin thinning, capsular contracture, wound…
- Conditions
- Breast Implant; Complications, Breast Implant Protrusion, Breast Cancer, Radiotherapy Side Effect
- Trial name
- BLITE-01 (NCT03737500)
- Testing
- B-Lite® light weight breast implant, Standard silicone-based breast implant
- Where
- Italy
- Volunteers
- 49 people
- Sponsor
- Istituti Clinici Scientifici Maugeri SpA