The Peak PlasmaBlade in DIEP free flap dissection
Research type
Research Study
Full title
The use of Peak plasmaBlade TM in DIEP/MS-TRAM breast reconstruction surgery compared to conventional diathermy - a single centre randomised control study
IRAS ID
192471
Contact name
Nitisha Narayan
Contact email
Sponsor organisation
Medtronic Advanced Energy
Duration of Study in the UK
0 years, 8 months, 1 days
Research summary
Breast reconstruction following breast cancer surgery can be done by using patient's own tissues or implants or a combination of both. A flap is tissue which has its own blood supply as opposed to a graft. Breast reconstruction can be done using regional or a free flap. A regional flap involves using tissue from the region which is raised with its blood supply but still attached to the body e.g a pedicled latissimus dorsi flap(muscle flap from back). A free flap is skin, fat or muscle tissue removed with its blood supply from one part of the body and transplanted to another. The deep epigastric perforator flap (DIEP) or its variant muscle sparing transverse rectus abdominis muscle flap (MS-TRAM) have become one of the most popular free flaps performed worldwide for breast reconstruction. In this operation skin and fatty tissue with or without muscle are raised from the patient’s abdominal wall along with its blood supply and attached to blood vessels of the chest wall. Different surgical devices are required and have important roles for the delivery of optimal precision during dissection and minimising soft tissue trauma, thus reducing operative and recovery time. Currently, the most common method used for dissection in DIEP operations is conventional diathermy, which works by delivery of an electric current to produce thermal ablation of tissue at around 200-350 degree C. Common complications seen during the wound healing process are seroma (excess tissue fluid), surgical site infections, haematoma (bleeding) and flap breakdown. These complications are related to the acute inflammatory response generated as a result of tissue injury.
An alternative cautery diathermy, the PEAK PlasmaBlade produced by Medtronic, works by producing high frequency pulses of radiofrequency energy at lower temperatures (40-100°C) than standard devices, therefore reducing the risk of thermal injury to the surrounding tissues. It has FDA approval in the US and is CE marked in Europe.
In this study, we plan to set up a randomised controlled trial to compare outcomes from using Peak PlasmaBlade with those from conventional diathermy for tissue dissection during DIEP reconstruction surgery. Our clinical outcomes include post-operative abdominal drainage duration and volume, pain score, inflammatory markers in drain fluid, wound healing complications.
REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
16/EE/0005
Date of REC Opinion
11 Feb 2016
REC opinion
Further Information Favourable Opinion