This trial is examining the effectiveness of a new type of surgical technique for mastectomy (surgical removal of the whole breast) in both breasts, followed by breast reconstruction. The main outcome that will be measured is blood flow in the operated area and pain. This study is recruiting in Baltimore, Maryland, in the United States.
The details
Surgery is an important part of the treatment for breast cancer. Newer surgical techniques involving heat are being researched to improve surgical outcomes. Electrosurgery is such a technique. It uses an electric current to heat up and cut tissues with great precision with limited blood loss. However, this high-frequency heat can cause side effects such as seroma (a collection of fluid on the surface of the cut skin) development. PlasmaBlade is an FDA approved device that uses a lower temperature than traditional electrosurgical devices.
This study is examining the effectiveness of PlasmaBlade compared to standard care electrosurgery. The main outcome will be how well fluid moves through the remaining breast tissue after surgery. Pain will also be evaluated.
Who are they looking for?
This study is looking for 20 patients with breast cancer planning to undergo a mastectomy on both breasts, followed by breast reconstruction. The patients must not have had radiotherapy before.
Patients will be excluded if they have any active connective tissue disease.
How will it work
In this study, both breasts will be removed. One breast will be removed using the new PlasmaBlade device, and the other will be removed using standard care electrosurgery. Immediately following the removal, breast reconstruction surgery will be performed.
The main outcome will be how well fluid moves through the remaining breast tissue and patient perceived pain after surgery.
