Clinical trials: Implant Based Breast Reconstruction
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
Breast Reconstruction
Impact of Pectoral Versus Paravertebral Blocks on Pain and Physical Well-Being in Implant-Based Breast Reconstruction
The broad aim of this study is to compare the effectiveness of paravertebral and pectoral blocks on pain and physical well-being of patients undergoing immediate implant-based breast reconstruction.
- Trial name
- NCT07209436
- Testing
- Paravertebral block (single injection), Pectoral block
- Where
- United States
- Volunteers
- 212 people
- Sponsor
- Amy Colwell
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
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
Pre-pectoral Breast Reconstruction PART 2
The rationale for present trial conception and design moves forward from the assumption that a subcutaneous, pre-pectoral reconstruction by means of soft tissue replacement devices is feasible, safe and giving rewarding results…
- Trial name
- PreBRec (NCT02831426)
- Testing
- Two-stage with Acellular Dermal Matrix (CELLIS® Breast), Two-stage with Titanium Coated Polypropylene Mesh (TiLOOOP® Bra)
- Where
- United Kingdom
- Volunteers
- 86 people
- Sponsor
- Guy's and St Thomas' NHS Foundation Trust
Patient and Surgical Related Risk Factors for Complications
TiLoop® Bra for Breast Reconstruction
A new approach for single stage implant based breast reconstruction (BR) is the use of a titanium-coated polypropylene mesh (TCPM) as an alternative to acellular dermal matrix (ADM).
- Trial name
- NCT01544023
- Volunteers
- 207 people
- Sponsor
- University of Rostock
Breast Cancer
Hypofractionated Radiation Fractionation in Breast Cancer Patients With Implant-Based Reconstruction
It is a randomized trial to assess the safety and efficacy between hypofractionation radiation and conventional radiation in women who have undergone mastectomy and immediate breast reconstruction.
- Trial name
- HFIBR (NCT06830083)
- Testing
- Hypofractionated Radiation Therapy, Conventional fraction radiotherapy
- Where
- China
- Volunteers
- 840 people
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University
Mastectomy, Breast Reconstruction
Evaluation of a Human Acellular Dermal Matrix in Post Mastectomy Reconstruction
Use of a HADM and implant in post-mastectomy breast reconstruction.
- Trial name
- NCT02263261
- Testing
- Flex HD Pliable Perforated HADM
- Where
- 2 sites in United States
- Volunteers
- 40 people
- Sponsor
- Musculoskeletal Transplant Foundation
Breast Cancer
Pre-pectoral Breast Reconstruction PART 1
The rationale for present trial conception and design moves forward from the assumption that a subcutaneous, pre-pectoral reconstruction by means of soft tissue replacement devices is feasible, safe and giving rewarding results…
- Trial name
- PreBRec (NCT02830685)
- Testing
- DTI with Acellular Dermal Matrix (CELLIS® Breast), DTI with Titanium Coated Polypropylene Mesh (TiLOOOP® Bra)
- Where
- United Kingdom
- Volunteers
- 131 people
- Sponsor
- Guy's and St Thomas' NHS Foundation Trust
Implant Based Breast Reconstruction
FlexHD® Pliable Investigation in Implant-Based Breast Reconstruction
Prospective, multi-center, single-arm clinical study in females undergoing immediate implant-based breast reconstruction using a pre-pectoral technique
- Trial name
- SHAPE (NCT06797258)
- Testing
- FlexHD® Pliable, No intervention
- Where
- United States
- Volunteers
- 259 people
- Sponsor
- Musculoskeletal Transplant Foundation
Breast Carcinoma, Breast Reconstruction
Prepectoral and Subpectoral Implant-based Breast Reconstruction
Breast cancer is one of the main malignant tumors threatening women's lives. In recent years, the increasing demand for reconstruction of breast cancer patients in China has made the proportion of breast reconstruction increase…
- Trial name
- NCT04688697
- Testing
- prepectoral implant-based reconstruction, subpectoral implant-based reconstruction
- Where
- China
- Volunteers
- 300 people
- Sponsor
- Fudan University
Mastectomy, Implant Based Breast Reconstruction
Assessment of the Interi Manifold in Implant-Based Breast Reconstruction
Patients with breast cancer that elect to undergo implant-based breast reconstruction (IBBR) often require the placement of a surgical drain.
- Trial name
- NCT05975359
- Testing
- Interi Manifold Drain System, Jackson Pratt Drain System
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Stanford University
Breast Cancer, Breast Reconstruction
Implant-based Breast Reconstruction in Post-bariatric Women - a Registry-based National Study
The goal of this national registry-based study is to investigate the prevalence of reconstructive breast surgery and risk factors for surgical complications in women who have had weight loss surgery previously.
- Conditions
- Breast Cancer, Breast Reconstruction, Bariatric Surgery, Breast Implant
- Trial name
- NCT07059104
- Testing
- Breast augmentation, Breast reconstruction after mastectomy
- Where
- Sweden
- Volunteers
- 20,000 people
- Sponsor
- Vastra Gotaland Region
Breast Reconstruction
Pulsed Lavage in Implant-Based Breast Reconstruction
To determine if there is any benefit to using pulsed lavage to wash out the mastectomy pocket during breast reconstruction. Primary outcomes will include post-op complications including surgical site infection (SSI), hematoma…
- Trial name
- NCT05585710
- Testing
- Pulsed Lavage Washout, Implant-based breast reconstruction, Bilateral or unilateral mastectomy
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- University of Alabama at Birmingham
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
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
Surgical Site Infection, Surgical Complication
A Novel Surgical Irrigation Solution in Post-Mastectomy Reconstruction: Evaluating Xperience™
Goal of the Clinical Trial: The purpose of this clinical trial is to learn whether Xperience™ surgical irrigation solution is more effective than a standard dilute povidone-iodine solution in reducing surgical site infections…
- Conditions
- Surgical Site Infection, Surgical Complication, Implant Infection, Implant Complication
- Trial name
- NCT06649890
- Testing
- Xperience™ Advanced Surgical Irrigation, Dilute Povidone-Iodine
- Where
- United States
- Volunteers
- 224 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
Breast Cancer, Breast Reconstruction
Single-Stage Prepectoral Placement of Textured Implants Using a Polyester Mesh Endoprostheses With Fluoropolymer Coating in Patients With Breast Cancer
This study aims to evaluate the efficacy of using a polyester mesh endoprosthesis with a fluoropolymer coating in reducing postoperative complications, particularly protrusions, following subcutaneous mastectomy with simultaneous…
- Conditions
- Breast Cancer, Breast Reconstruction, Coated Materials, Reconstruction Breast Surgery
- Trial name
- FluoropolyMesh (NCT07185334)
- Testing
- Subcutaneous mastectomy using a fluoropolymer-coated polyester mesh endoprosthesis with simultaneous prepectoral placement of textured implants., Subcutaneous mastectomy with simultaneous prepectoral placement of textured implants.
- Where
- Russia
- Volunteers
- 100 people
- Sponsor
- Saint Petersburg State University, Russia
Breast Neoplasms
Application of Intra-operative Prophylactic Antibiotics/Antiseptics in Chinese Breast Reconstruction Patients
The study aims to investigate different approaches of local application of antibiotics/antiseptics intraoperatively in Chinese patients undergoing post-mastectomy implant based breast reconstruction, and aims to single out an…
- Trial name
- NCT03742908
- Testing
- Cefazolin/clindamycin
- Where
- China
- Volunteers
- 291 people
- Sponsor
- Tianjin Medical University Cancer Institute and Hospital
Breast Reconstruction
The Use of Alloderm Versus Dermacell in Immediate Implant Based Breast Reconstruction
Breast reconstruction after mastectomy has been shown to provide psychosocial benefits to breast cancer patients and is considered an integral part of breast cancer treatment.
- Trial name
- REaCT-ADM (NCT03064893)
- Testing
- Alloderm, Dermacell
- Where
- Canada
- Volunteers
- 62 people
- Sponsor
- Ottawa Hospital Research Institute