Comparison of PEAK PlasmaBlade™ to Conventional Diathermy in Abdominal Based Free Flap Breast Reconstruction
Condition: Breast Reconstruction; Breast Cancer
MeSH terms: Hyperthermia
Study type: Interventional

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.
    

Detailed description: 
      The study was conducted between November 2016 and May 2018 in a single centre, St. Andrew's
      Centre for Plastic Surgery and Burns in Broomfield Hospital, in Chelmsford United Kingdom,
      including all immediate and delayed DIEP/MS-TRAM patients of two senior plastic surgeons, who
      agreed to participate and met the in-/exclusion criteria. All participants signed an informed
      consent. Randomisation was performed using the Trans European Network for Clinical Trials
      Service (TENALEA), which is an internet-based randomisation system. Patients were either
      allocated to the 'Group A - diathermy' or 'Group B - PEAK PlasmaBlade™. Blinding was broken
      after the last patient had completed the 6-week follow-up period.

      All patients underwent a standardised DIEP or MS-TRAM breast reconstruction procedure. A
      scalpel was used to make the skin incision to the depth of the dermis. The raising of the
      flap was subsequently done either using the PEAK Plasma Blade™ or conventional diathermy.
      Before the abdominal closure two 15 French Blake drains were inserted and secured to the skin
      with a 2.0 Silk suture and connected to a low vacuum wound drainage system (85 kPa/neg
      100mmHg). Every patient would wear an abdominal binder (9-inch, Marena) for 6 weeks
      post-operatively. Data on drain requirement, total daily abdominal drainage, pain, mobility
      and complications were collected during the inpatient stay. On day 0,1 and 2 also abdominal
      drain fluid was obtained. This was stored in labelled 1.5mL Eppendorf tubes in a -80°C
      freezer. The samples were sent to Myriad RBM, Inc. a clinical laboratory improvement
      amendments (CLIA) certified biomarker testing laboratory located in Austin, Texas (United
      States) for inflammatory cytokine analysis. Abdominal drains were removed when draining 30mL
      or less in 24 hours. Following discharge, patients were seen in the outpatient department
      after two and six weeks. At both follow-up appointments, data on complications were recorded.
      Also an abdominal ultrasound was performed using the V-Universal™ Stand portable ultrasound
      machine (SonoSite, Inc) to identify and measure abdominal seroma collections. Seromas were
      only aspirated if they were causing discomfort to the patient. After completion of the 6-week
      follow-up period patients were discharged from the study. All data were collected by the
      blinded principle study investigator and logged onto an electronic database.

      Data from an in the investigator's unit conducted pilot study on drain requirement was used
      to perform a power calculation.This results in a minimal sample size of 53 patients for each
      group (106 overall).

      Normal distribution was evaluated using the Shapiro-Wilk test, following this continuous data
      was analysed using the independent sample t-test or Mann-Whitney U Test to identify a
      statistically significant difference between the two groups. All right skewed was log
      transformed, if this resulted in a normal distribution the independent samples t-test was
      used to determine statistical significance. For categorical data the Pearson Chi-Square Test
      for numbers over 5 was used. If the count was equal to or less than 5 the Fisher's Exact Test
      was used to determine statistical significance. A value below or equal to 0.05 (2-tailed) was
      considered to be statistically significant. Linear regression (Cox proportional hazard model)
      was used to identify significant determinants for the time to drain removal. Variables that
      had a significant p-value in the univariate analysis were included in a multivariable
      analysis. Significant determinants could indicate confounding factors for which would be
      corrected. Logistic regression was used to identify determinants for complications and the
      presence of seroma at the 2- and 6-week abdominal ultrasound scan. Variables that had a
      significant p-value in the univariate analysis were included in multivariable analysis, if
      none of the determinates were significant p values <0.10 were included in the multivariable
      analysis. Significant determinants could indicate confounding factors for which would be
      corrected.
    

Intervention name(s): Conventional diathermy; PEAK PlasmaBlade™
Intervention type(s): Device; Device
Intervention description(s): Abdominal free flap raise performed with conventional diathermy. Settings: cutting 40 Watt, coagulation 40 Watt.; Abdominal free flap raise performed with PEAK PlasmaBlade™ Settings: cutting 7 (35 Watt), coagulation 7 (35 Watt)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients randomised between having their procedure performed with one of two different electrosurgery devices
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Electrosurgery; Conventional diathermy; PEAK PlasmaBlade™; Deep Inferior Epigastric Perforator (DIEP) flap; Drain; Seroma