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

NCT04350411 | Completed

• 1 other identifier: 16/17 086
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Electrosurgery; Conventional diathermy; PEAK PlasmaBlade™; Deep Inferior Epigastric Perforator (DIEP) flap; Drain; Seroma

Outcome Measures

Primary Outcomes (1)

• Number of days the abdominal drains were required

  Number of days post operative

  Drain requirement from the day of operation (day 0) until the day the drain was removed when producing 30ml or less/ 24 hours

Secondary Outcomes (10)

• Flap raise time

  Data recorded during operation

• Weight of abdominal flap

  Data recorded during operation

• Inflammatory markers in abdominal drain fluid on day 0,1 and 2

  Drain fluid on day 0, 1 and 2

• Pain score

  Recorded twice a day (morning and afternoon) while an inpatient (between 3 - 14 days)

• Mobility

  While an inpatient (between 3 - 14 days)

Study Arms (2)

Conventional diathermy

EXPERIMENTAL

DIEP/ MS-TRAM breast reconstruction free flap raise performed with conventional diathermy

Device: Conventional diathermy

PEAK PlasmaBlade™

EXPERIMENTAL

DIEP/ MS-TRAM breast reconstruction free flap raise performed with PEAK PlasmaBlade™

Device: PEAK PlasmaBlade™

Interventions

Conventional diathermy DEVICE

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

Conventional diathermy

PEAK PlasmaBlade™ DEVICE

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

PEAK PlasmaBlade™

Eligibility Criteria

• Age: 18 Years - 80 Years
• Gender Eligibility Details: Females undergoing immediate or delayed abdominal based free flap breast reconstruction
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults between 18-80 years, able to consent
• Unilateral immediate or delayed DIEP/ MS-TRAM breast reconstruction
• BMI \>20

You may not qualify if:

• Children (\<18 years) and adults older than 80 years
• Bilateral or bi-pedicled DIEP/MS-TRAM breast reconstruction
• BMI \<20
• Diabetic
• Immune-suppression
• Clotting disorders
• On steroid medication
• Pregnancy
• Active smoking

Sponsors & Collaborators

• Anglia Ruskin University: lead
• Mid Essex Hospital NHS Trust: collaborator
• Medtronic: collaborator

Study Sites (1)

Mid Essex NHS trust

Chelmsford, Essex, CM17ET, United Kingdom

Location

Related Publications (5)

• Massarweh NN, Cosgriff N, Slakey DP. Electrosurgery: history, principles, and current and future uses. J Am Coll Surg. 2006 Mar;202(3):520-30. doi: 10.1016/j.jamcollsurg.2005.11.017. No abstract available.

  PMID: 16500257 BACKGROUND

• Yilmaz KB, Dogan L, Nalbant H, Akinci M, Karaman N, Ozaslan C, Kulacoglu H. Comparing scalpel, electrocautery and ultrasonic dissector effects: the impact on wound complications and pro-inflammatory cytokine levels in wound fluid from mastectomy patients. J Breast Cancer. 2011 Mar;14(1):58-63. doi: 10.4048/jbc.2011.14.1.58. Epub 2011 Mar 31.

  PMID: 21847396 BACKGROUND

• Loh SA, Carlson GA, Chang EI, Huang E, Palanker D, Gurtner GC. Comparative healing of surgical incisions created by the PEAK PlasmaBlade, conventional electrosurgery, and a scalpel. Plast Reconstr Surg. 2009 Dec;124(6):1849-1859. doi: 10.1097/PRS.0b013e3181bcee87.

  PMID: 19952641 BACKGROUND

• Ruidiaz ME, Messmer D, Atmodjo DY, Vose JG, Huang EJ, Kummel AC, Rosenberg HL, Gurtner GC. Comparative healing of human cutaneous surgical incisions created by the PEAK PlasmaBlade, conventional electrosurgery, and a standard scalpel. Plast Reconstr Surg. 2011 Jul;128(1):104-111. doi: 10.1097/PRS.0b013e31821741ed.

  PMID: 21701326 BACKGROUND

• Dogan L, Gulcelik MA, Yuksel M, Uyar O, Erdogan O, Reis E. The effect of plasmakinetic cautery on wound healing and complications in mastectomy. J Breast Cancer. 2013 Jun;16(2):198-201. doi: 10.4048/jbc.2013.16.2.198. Epub 2013 Jun 28.

  PMID: 23843853 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Hyperthermia; Seroma

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heat Stress Disorders; Wounds and Injuries; Inflammation; Pathologic Processes

Study Officials

• Thessa R Friebel, MSc

  Mid Essex NHS trust

  PRINCIPAL INVESTIGATOR

• Matthew Griffiths, MBBS, MD

  Mid Essex NHS trust

  STUDY DIRECTOR

• Selim Cellek, MD, PhD

  Anglia Ruskin University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Patients and investigator collecting data were both blinded for which machine was used
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients randomised between having their procedure performed with one of two different electrosurgery devices

Study Record Dates

• First Submitted: April 6, 2020
• First Posted: April 17, 2020
• Study Start: October 31, 2016
• Primary Completion: April 24, 2018
• Study Completion: May 31, 2018
• Last Updated: April 17, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)