Clinical trials: Tissue Expander Based Breast Reconstruction
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
Surgical Site Infection, Breast Reconstruction
Surgical Site Infection and Antibiotic Use Study
This study is a prospective, multi-institutional, noninferiority, randomized control trial that will compare the efficacy of two antibiotic treatments in preventing SSI in patients receiving immediate breast reconstruction with…
- Conditions
- Surgical Site Infection, Breast Reconstruction, Antibiotic Use
- Trial name
- ASSERT (NCT04631185)
- Testing
- Single pre-operative dose of intravenous antibiotics with intraoperative redosing, One week of post-operative antibiotics
- Where
- 5 sites in United States
- Volunteers
- 235 people
- Sponsor
- The Plastic Surgery Foundation
Complications; Breast Prosthesis, Infection or Inflammation
Antibiotics and Tissue Expanders in Breast Reconstruction
This study is a randomized controlled non-blinded double arm study examining the effect of routine postoperative oral antibiotic therapy in preventing postoperative surgical site infections after breast reconstruction.
- Trial name
- NCT01899690
- Testing
- antibiotic
- Sponsor
- Emory University
Mastectomy, Infections
Reusable Versus Disposable Draping System in Breast Reconstruction Surgery
This study will look at the rate of infections developed by subjects comparing the use of disposable draping systems versus reusable draping systems in the operating room.
- Conditions
- Mastectomy, Infections, Breast Reconstruction
- Trial name
- NCT01176786
- Testing
- Culture Swabs, Rodac Plate Cultures
- Where
- United States
- Volunteers
- 107 people
- Sponsor
- Wake Forest University Health Sciences
Breast Cancer
Study to Compare the Safety of Immediate One-stage IBBR With Expander-Implant Two-stage IBBR Augmented With TiLoop® Bra(COSTA)
This study is the first prospective randomized study assessing the safety and patient-reported outcomes of immediate one-stage IBBR compared with those of two-stage IBBR with TiLoop® Bra.
- Trial name
- IBBR (NCT03589924)
- Testing
- Immediate IBBR+TiLoop®Bra, Immediate-delayed IBBR+TiLoop®Bra
- Where
- 11 sites in China
- Volunteers
- 440 people
- Sponsor
- Jiong Wu
Breast Cancer
Implant-based Breast Reconstruction and Mastectomy With Fat Grafting After Breast Conserving Surgery and Radiotherapy
Higher rates of complications and poorer cosmetic outcomes have been reported after salvage mastectomy and implant-based versus autologous reconstruction in patients previously exposed to radiation therapy (i) on the breast as…
- Trial name
- NCT06119633
- Testing
- Immediate tissue expander and lipofilling after mastectomy
- Where
- 2 sites in Italy
- Volunteers
- 163 people
- Sponsor
- Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
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
Tissue Expander Based Breast Reconstruction
Local Antibiotic Concentrations With Tissue Expanders in Breast Reconstruction
Infections after tissue expander breast reconstruction can lead to pain, additional surgeries, and loss of the reconstruction. This study will compare two types of antibiotic carriers used during surgery to help lower the risk of…
- Trial name
- NCT07339215
- Testing
- Antibiotic loaded calcium sulfate beads, Polymethylmethacrylate antibiotic disc
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- University of California, Davis
Breast Cancer, Operable Breast Cancer
EXpander-based Versus Direct to Implant PRE-pectoral Breast Reconstruction: a Comparative Analysis of Surgical Outcomes
Recent advances in breast surgery, together with the increasing adoption of conservative surgical approaches, have renewed interest in pre-pectoral implant-based breast reconstruction.
- Trial name
- EXPRESSO (NCT07593651)
- Volunteers
- 276 people
- Sponsor
- IRCCS San Raffaele
Breast Carcinoma, Breast Disorder
Blossom Smart Expander Technology in Breast Reconstruction in Participants With Breast Cancer Undergoing Mastectomy
This phase 1 trial studies how well Blossom Smart Expander Technology works in breast reconstruction in participants with breast cancer undergoing mastectomy.
- Trial name
- NCT03657069
- Testing
- Blossom, Breast-Q -Reconstruction module (preoperative) version 2.0 satisfaction with breasts questionnaire
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Stanford University
Breast Cancer
Cost-Effectiveness of Abdominal-based Autogenous Tissue vs Tissue Expander-Implant Reconstruction - A Feasibility Study
It is estimated that about 25% and 40% of health care expenditures in Canada and USA respectively are wasted because of inefficiencies and not practicing evidence-based medicine.
- Trial name
- NCT02438449
- Testing
- Breast Reconstruction Surgery
- Where
- Canada
- Volunteers
- 61 people, healthy volunteers welcome
- Sponsor
- McMaster University
Malignant Neoplasm of the Breast, Acquired Absence of the Breast
Evaluating AlloMax in Immediate Expander-Based Breast Reconstruction Study
The study is a prospective multi-centered cohort study designed to determine the safety and efficacy of AlloMax in immediate expander-based breast reconstruction.
- Trial name
- NCT01372917
- Where
- United States
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- National Center for Plastic Surgery, Virginia
Breast Reconstruction Surgery
Tissue Reinforcement for Breast Reconstruction (TRBR) Pivotal Clinical Study (REDEFINE)
The GORE Tissue Reinforcement for Breast Reconstruction (TRBR) research study will look at breast reconstruction during mastectomy procedures.
- Trial name
- NCT06556654
- Testing
- TRBR Device
- Where
- 20 sites in United States
- Volunteers
- 180 people
- Sponsor
- W.L.Gore & Associates
Mammaplasty
The Use of Pecs Blocks in Combination With Exparel in Breast Reconstruction Surgery
This project intends to more thoroughly investigate the direct influence of Pecs blocks in the administration of Exparel, a non-opioid analgesic, in breast reconstruction surgery.
- Trial name
- NCT05171179
- Testing
- Breast Reconstruction (Mammaplasty), Pecs blocks, Exparel
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Northwestern University
Capsular Contracture Associated With Implant, Foreign-Body Reaction
Experimental and Clinical Investigation of the Implant Surface Roughness Reduction Effect on Early-stage Fibrosis
The goal of this single-center, randomised double-blinded trial is to compare the early stage fibrosis progression around conventional textured expander and the SmoothSilk® expander with reduced surface roughness in women…
- Conditions
- Capsular Contracture Associated With Implant, Foreign-Body Reaction, Wounds and Injuries, Tissue Expander Disorder
- Trial name
- NCT05648929
- Testing
- Patient Satisfaction Questionnaire, Pregnancy test, Blood draw
- Where
- Austria
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Medical University Innsbruck
Tissue Expansion, Implant Based Breast Reconstruction
Blossom® Smart Expander Device for Tissue Expander/Implant-Based Breast Reconstruction
The conventional breast tissue expander used for breast reconstruction/ augmentation requires weekly or biweekly injections of saline through the skin and into an integrated port in the implant using a needle and syringe in order…
- Trial name
- NCT05975372
- Testing
- Blossom tissue expander, Standard tissue expansion
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Stanford University
Breast Cancer Female, Breast Cancer Prevent
First-in-human, Study of MATTISSE® Tissue Engineering Chamber in Adult Female Patients Undergoing Breast Reconstruction After Mastectomy for Cancer
This study is a first in human, two-stage single arm non-comparative study of safety and performance. The aim of the study is to asses the safety and the clinical performance of a new device : the MATTISSE tissu engineering…
- Conditions
- Breast Cancer Female, Breast Cancer Prevent, Breast Reconstruction
- Trial name
- TIDE (NCT05460780)
- Testing
- MATTISSE TEC
- Where
- 3 sites in France, Georgia
- Volunteers
- 50 people
- Sponsor
- Quanta Medical