Breast Reconstruction Clinical Trial
Official title:
A Randomised Controlled Trial Comparing 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. In general, breast reconstruction can be accomplished using the patients own tissues or implantable prosthetic devices. Various acellular dermal matrices (ADMs) are offered on the market and the costs vary widely despite very similar qualities. The two most commonly used ADM products in North America by far are Dermacell and Alloderm. The difference between the two products include a) level of sterility, with Dermacell being sterilized to 10-9 while Alloderm is sterilized to 10-6 and b) the consistency and thickness of the biologic material and c) a significant different in cost ($2200 CAD vs $3600, respectively). Each product has shown to be safe and effective. As such, clinical equipoise exists. This will be a pragmatic trial to evaluate Dermacell with Alloderm in a head to head randomized fashion, with regards to the postoperative complications, namely infection, seroma formation (as measured by drain duration and output), loss of implant, incidence of revisional surgery and capsular contracture.
n/a
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT03757793 -
Near-infrared Spectroscopy for Monitoring Tissue Oxygenation in Breast Reconstruction
|
||
Completed |
NCT05491473 -
Negative Pressure in PAP Donor Sites
|
||
Not yet recruiting |
NCT06013514 -
Post-market Prospective Clinical Study of Nagor Perle Mammary Implants
|
||
Completed |
NCT02169011 -
Secondary Breast Reconstruction With a Flap of Skin From the Back
|
N/A | |
Completed |
NCT01216319 -
Evaluation of the Cook Biodesign Plastic Surgery Matrix
|
N/A | |
Completed |
NCT01176786 -
Reusable Versus Disposable Draping System in Breast Reconstruction Surgery
|
N/A | |
Not yet recruiting |
NCT00973544 -
Do Closed Suction Drains Affect the Complications Rate of Breast Reconstruction With Silicone Prosthesis?
|
N/A | |
Active, not recruiting |
NCT00748722 -
Pre-Operative Imaging of Abdominal Wall Perforators Using CT Angiography
|
N/A | |
Completed |
NCT00753922 -
Core Gel Study of the Safety and Effectiveness of Mentor Round Low Bleed Silicone Gel-filled Mammary Prostheses
|
Phase 3 | |
Completed |
NCT05897463 -
Nipple Neurotization
|
||
Recruiting |
NCT05377723 -
Abdominal Scar Improvement in Microsurgical Breast Reconstruction
|
N/A | |
Completed |
NCT04350411 -
Comparison of PEAK PlasmaBladeā¢ to Conventional Diathermy in Abdominal Based Free Flap Breast Reconstruction
|
N/A | |
Completed |
NCT06321549 -
New Era of DIEP With Minimally Invasive Mastectomy
|
||
Withdrawn |
NCT03135392 -
Sensation After Nipple Sparing Mastectomy and Breast Reconstruction With or Without Neurotized Free Tissue Transfer
|
N/A | |
Completed |
NCT01256502 -
The SERI® Surgical Scaffold Use in Reconstruction Post Market Study for Tissue Support and Repair in Breast Reconstruction Surgery
|
N/A | |
Active, not recruiting |
NCT04715802 -
Options on the Breast Reconstruction Timing and Method After Removal of Polyacrylamide Hydrogel
|
||
Active, not recruiting |
NCT04491591 -
Implementing BREASTChoice Into Practice
|
N/A | |
Recruiting |
NCT04661501 -
BREAST ADM Trial for Alloplastic Breast Reconstruction
|
N/A | |
Suspended |
NCT03625765 -
Integrated Imaging System for In Vivo Visualization of Free Flap Perfusion Using Indocyanine Dye
|
N/A | |
Withdrawn |
NCT00778947 -
Single Centre Study to Compare Harmonic Scalpel to Conventional Diathermy in Free Tissue Transfer Breast Reconstruction
|
N/A |