Clinical trials: Implant Based Breast Reconstruction
Breast Reconstruction, Flap Necrosis
a Prospective Study of Surgical Results, Complications and Predictive Values in Chinese Women Breast Reconstruction
This study prospectively evaluates and compares the effectiveness of ICG fluorescence imaging and LSCI in predicting the risk of necrosis following direct-to-implant breast reconstruction.
- Trial name
- BEST (NCT06779019)
- Testing
- LSCI, ICG (Indocyanine Green)
- Where
- China
- Volunteers
- 40 people
- Sponsor
- Peking Union Medical College Hospital
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
Mastectomy
RCT Implant Based Breast Reconstruction
The main objective of this study is to evaluate patients undergoing mastectomy with immediate implant-based breast reconstruction and compare the outcomes of patients who are discharged the day of surgery versus patients who are…
- Trial name
- NCT04558138
- Testing
- Discharge timing
- Where
- United States
- Volunteers
- 123 people
- Sponsor
- University of Colorado, Denver
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
Breast Reconstruction Following Mastectomy
Prepectoral vs Partial Subpectoral Two-Stage Implant-Based Breast Reconstruction
The purpose of this study is to investigate the to analyze the patient satisfaction and complication rates under controlled conditions of the increasingly popular prepectoral technique for implant-based breast reconstruction.
- Trial name
- NCT04874402
- Testing
- Prepectoral approach, Partial Subpectoral approach
- Where
- United States
- Sponsor
- Case Comprehensive Cancer Center
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 Reconstruction
Direct to Implant Breast Reconstruction Based Pre- or Retropectoral
The purpose of this study is to examine different outcomes of breast reconstruction in women who are treated for breast cancer with skin sparing mastectomy and subsequently a primary implant based reconstruction by one of two…
- Trial name
- NCT03143335
- Testing
- Retropectoral immediate breast reconstruction, Prepectoral immediate breast reconstruction
- Where
- 3 sites in Denmark, Norway
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Odense 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
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 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 Cancer, Breast Carcinoma in Situ
Immediate Breast Reconstruction With Acellular Dermal Matrix
The aim of this study is to contribute to the knowledge regarding immediate implant-based BR by investigating whether the one-stage technique with ADM is superior to the two-stage expander to implant technique.
- Conditions
- Breast Cancer, Breast Carcinoma in Situ, Mammaplasty, Acellular Dermis
- Trial name
- NCT04209010
- Testing
- one-stage technique
- Volunteers
- 44 people
- Sponsor
- Aarhus University Hospital
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
Breast Cancer, Postoperative Pain
Liposomal Bupivacaine in Implant Based Breast Reconstruction
Objectives: 1. To evaluate the effect of liposomal bupivacaine on postoperative pain levels. 2. To evaluate the effect of liposomal bupivacaine on postoperative opioid consumption and opioid related adverse events. 3.
- Trial name
- NCT02659501
- Testing
- Liposomal bupivacaine, Bupivacaine with epinephrine, Morphine sulfate
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Loma Linda 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 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
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 Cancer, Implant Breast Reconstruction
Neoadjuvant Radiotherapy and Immediate Implant-Based Breast Reconstruction
Neoadjuvant radiotherapy(NART) followed by mastectomy and immediate DIEP flap reconstruction is feasible and technically safe. However, reports of NACT followed immediate implant-based breast reconstruction are rare.
- Conditions
- Breast Cancer, Implant Breast Reconstruction, Neoadjuvant Radiotherapy
- Trial name
- NCT05992870
- Testing
- Neoadjuvant radiotherapy
- Where
- China
- Volunteers
- 40 people
- Sponsor
- Hubei Cancer Hospital
Infections, Quality of Life
Effect of Drain Care on Infection Rate and Quality of Life in Implant-Based Breast Reconstruction.
The goal of this clinical trial is to learn whether showering with surgical drain tubes in place after first stage breast reconstruction causes increased risk of infection.
- Trial name
- NCT05846438
- Testing
- Showering 48 hours after surgery
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- University of Missouri-Columbia
Breast Reconstruction Following Mastectomy
Safety and Clinical Performance of a Biological Matrix Used in Implant-based Breast Reconstruction
The general objective of the study is to confirm the medium/long-term safety and clinical performance of the CELLIS Breast membranes used in breast reconstruction and to identify emerging risks in comparison to clinical data…
- Trial name
- NCT05031962
- Testing
- CELLIS Breast (Porcine Acellular Dermal Matrix, PADM)
- Where
- 10 sites in France
- Volunteers
- 112 people
- Sponsor
- Meccellis Biotech
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