What's New
NewYork-Presbyterian/Columbia Division of Plastic Surgery investigates new tissue expansion system for breast reconstruction patients
Jeffrey Ascherman, MD |
Jeffrey Ascherman, MD, is the first physician in the United States to enroll patients in a study of a new, needle-free tissue expansion method that may allow women to prepare for reconstructive breast surgery in a much easier manner than traditional techniques.
After mastectomy, breast cancer patients who wish to have reconstructive surgery often undergo a process by which a space to accommodate a breast implant is created under the patient's remaining skin.
The standard process entails injections of saline every few weeks to gradually expand the skin and muscle in the chest to allow placement of a permanent implant.
Some women find that not only are the injections painful, but frequent visits to the hospital for 4 to 6 months or more may present a significant burden.
NewYork-Presbyterian/Columbia is the first center in the U.S. to receive Institutional Review Board (IRB) approval for a trial of the new technique, which eliminates the need for frequent saline injections and hospital visits.
This investigational method first requires implantation of a small expander device.
Once at home, the patient uses a remote-control device to release small amounts of compressed carbon-dioxide from a valve in the expander. In a recent study of the device in Australia, the daily expansion resulted in creation of a pocket in an average of 15 days that was comparable to those created after several months of saline injections.
Patients can use the new needle-free technology while at home, at their own pace and comfort level.
The randomized controlled clinical study is designed to directly compare the outcomes of traditional saline expansion method to the investigational, remote-controlled tissue expander.
NYP/Columbia is the only hospital in New York, and one of only approximately ten hospitals in the U.S., to participate.
The U.S. Food and Drug Administration (FDA) has granted an Investigational Device Exemption (IDE) to conduct the study, and the trial has received approval for enrollment by the Columbia University Medical Center IRB.
Eligible patients include non-obese women between 18 - 65 years of age who do not smoke, have not had previous tissue expansion or radiation therapy, and who want breast reconstruction with tissue expansion after mastectomy.
For more information about this trial, see clinicaltrials.gov.
To inquire about enrolling in this study, or to refer a patient, please contact:
Jeffrey Ascherman, MD
Site Chief, Division of Plastic Surgery
NewYork-Presbyterian Hospital/Columbia University Medical Center
Tel: (212) 305-9612
|
