Comparison of PEAK PlasmaBlade™ to Conventional Diathermy in Abdominal Based Free Flap Breast Reconstruction

Summary

Electrosurgery allows for dissection with simultaneous haemostasis. One of its disadvantages is that the heat production can cause injury to the surrounding tissue which may result in wound healing problems and an increased rate of seromas.

The PEAK PlasmaBlade™ (PPB) is a new electrosurgery device which may overcome this by having the ability to operate on a lower temperature, therefore reducing collateral thermal damage.

Different experimental studies in both animal and human models comparing the PEAK PlasmaBlade™ and other surgical dissection devices for incisions have shown a reduction in width of zone of thermal injury, reduction in wound inflammation, increased wound strength and reduced scaring in favour of the PEAK PlasmaBlade™ and comparable to scalpel incisions. A prospective clinical study published by Dogan et al. in 2013, including 46 consecutive breast cancer patients receiving a modified radical mastectomy either with the conventional diathermy (n=22) or the PEAK PlasmaBlade™ (n=24), showed a statistically significant reduction in wound fluid production (p=0.025), leading to earlier drain removal (p=0.020) in the PEAK PlasmaBlade™ group.

Comparable to oncological breast surgery, prolonged drain requirements for high wound fluid production and seromas are often experienced in the abdominal donor side after deep inferior epigastric perforator/ muscle sparing transverse rectus abdominis muscle flap (DIEP/MS-TRAM) breast reconstruction. To evaluate the effects of the PEAK PlasmaBlade™ for abdominal dissection in autologous breast reconstruction on wound fluid production and complications such a seroma, this double blinded randomised controlled clinical trial was conducted.

It was hypothesised the use of the PEAK PlasmaBlade™ for the harvest of the DIEP/ MS-TRAM flap would result in 1) a shorter abdominal drains requirement (days); 2) a lower total drainage volume (mL) from the abdominal drains; 3) lower levels of inflammatory cytokines in the drain fluid and 4) less and smaller seromas would be identified using ultrasound in the follow-up period.

Conditions

• Breast Reconstruction
• Breast Cancer

Interventions

DEVICE

Conventional diathermy

Abdominal free flap raise performed with conventional diathermy. Settings: cutting 40 Watt, coagulation 40 Watt.

DEVICE

PEAK PlasmaBlade™

Abdominal free flap raise performed with PEAK PlasmaBlade™ Settings: cutting 7 (35 Watt), coagulation 7 (35 Watt)

Sponsors & Collaborators

• Mid Essex Hospital NHS Trust

  collaborator OTHER

• Medtronic

  collaborator INDUSTRY

• Anglia Ruskin University

  lead OTHER

Principal Investigators

• Thessa R Friebel, MSc · Mid Essex NHS trust

• Matthew Griffiths, MBBS, MD · Mid Essex NHS trust

• Selim Cellek, MD, PhD · Anglia Ruskin University

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-10-31

Primary Completion

2018-04-24

Completion

2018-05-31

Countries

• United Kingdom

Study Locations