- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04350411
Comparison of PEAK PlasmaBlade™ to Conventional Diathermy in Abdominal Based Free Flap Breast Reconstruction
Comparison of PEAK PlasmaBlade™ to Conventional Diathermy in Abdominal Based Free Flap Breast Reconstruction - a Single Centre, Double Blinded Randomised Controlled Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Essex
-
Chelmsford, Essex, United Kingdom, CM17ET
- Mid Essex NHS trust
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adults between 18-80 years, able to consent
- Unilateral immediate or delayed DIEP/ MS-TRAM breast reconstruction
- BMI >20
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Conventional diathermy
DIEP/ MS-TRAM breast reconstruction free flap raise performed with conventional diathermy
|
Abdominal free flap raise performed with conventional diathermy.
Settings: cutting 40 Watt, coagulation 40 Watt.
|
Experimental: PEAK PlasmaBlade™
DIEP/ MS-TRAM breast reconstruction free flap raise performed with PEAK PlasmaBlade™
|
Abdominal free flap raise performed with PEAK PlasmaBlade™ Settings: cutting 7 (35 Watt), coagulation 7 (35 Watt)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of days the abdominal drains were required
Time Frame: Drain requirement from the day of operation (day 0) until the day the drain was removed when producing 30ml or less/ 24 hours
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Flap raise time
Time Frame: Data recorded during operation
|
Time required to raise abdominal flap (minutes)
|
Data recorded during operation
|
Weight of abdominal flap
Time Frame: Data recorded during operation
|
Weight of raised abdominal flap in grams
|
Data recorded during operation
|
Inflammatory markers in abdominal drain fluid on day 0,1 and 2
Time Frame: Drain fluid on day 0, 1 and 2
|
Inflammatory markers in abdominal drain fluid: TNF-alpha, IL-4, IL-6,IL-8, IL-10, IL-18, MIP-1 alpha, MIP-1 beta, MCP-1
|
Drain fluid on day 0, 1 and 2
|
Pain score
Time Frame: Recorded twice a day (morning and afternoon) while an inpatient (between 3 - 14 days)
|
Numerical rating scale (NRS) 0 to 10 (with 0 being no pain and 10 the worse pain imaginable)
|
Recorded twice a day (morning and afternoon) while an inpatient (between 3 - 14 days)
|
Mobility
Time Frame: While an inpatient (between 3 - 14 days)
|
Number of steps a day
|
While an inpatient (between 3 - 14 days)
|
Total abdominal drain fluid output
Time Frame: Total amount of abdominal drain fluid collected at time of drain removal (between 3 - 14 days post-operatively)
|
Total amount of fluid drained from abdominal wound (millilitres) during admission
|
Total amount of abdominal drain fluid collected at time of drain removal (between 3 - 14 days post-operatively)
|
Complications
Time Frame: In the 6-week follow-up period
|
Number of complications during the study experienced by each patient (for example: Flap problems, haematoma, delayed abdominal wound healing, seroma)
|
In the 6-week follow-up period
|
Interventions for complications
Time Frame: In the 6-week follow-up period
|
Number of interventions required to deal with complication for each patient (for example needle aspiration, surgery, iv antibiotics)
|
In the 6-week follow-up period
|
Seroma presence on abdominal ultrasound
Time Frame: At the 2- and 6-week follow-up appointments
|
Abdominal ultrasound to identify
|
At the 2- and 6-week follow-up appointments
|
Size of seroma collection on abdominal ultrasound
Time Frame: At the 2- and 6-week follow-up appointments
|
Size (length, width and depth was measured and used to estimate the size using the formula of half an ellipse)
|
At the 2- and 6-week follow-up appointments
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Thessa R Friebel, MSc, Mid Essex NHS trust
- Study Director: Matthew Griffiths, MBBS, MD, Mid Essex NHS trust
- Study Director: Selim Cellek, MD, PhD, Anglia Ruskin University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16/17 086
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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