An interventional study of Conventional diathermy and PEAK PlasmaBlade™ in Breast Reconstruction and Breast Cancer, sponsored by Anglia Ruskin University. Completed at 1 site in United Kingdom. Open to female participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-04-17.
Sponsored by Anglia Ruskin University · Not applicable, Interventional, and Other
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.
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.
478 studies on the registry are indexed under Hyperthermia; 92 are open to participants now.
This study's enrollment of 108 is above the median of 60 across 365 interventional studies indexed under Hyperthermia.
Browse Hyperthermia studies →Anglia Ruskin University is the lead sponsor of 35 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
DIEP/ MS-TRAM breast reconstruction free flap raise performed with conventional diathermy
Device: Conventional diathermy
DIEP/ MS-TRAM breast reconstruction free flap raise performed with PEAK PlasmaBlade™
Device: PEAK PlasmaBlade™
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)
Number of days the abdominal drains were required
Number of days post operative
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
Flap raise time
Time required to raise abdominal flap (minutes)
Time frame: Data recorded during operation
Weight of abdominal flap
Weight of raised abdominal flap in grams
Time frame: Data recorded during operation
Inflammatory markers in abdominal 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
Time frame: Drain fluid on day 0, 1 and 2
Pain score
Numerical rating scale (NRS) 0 to 10 (with 0 being no pain and 10 the worse pain imaginable)
Time frame: Recorded twice a day (morning and afternoon) while an inpatient (between 3 - 14 days)
Mobility
Number of steps a day
Time frame: While an inpatient (between 3 - 14 days)
Total abdominal drain fluid output
Total amount of fluid drained from abdominal wound (millilitres) during admission
Time frame: Total amount of abdominal drain fluid collected at time of drain removal (between 3 - 14 days post-operatively)
Complications
Number of complications during the study experienced by each patient (for example: Flap problems, haematoma, delayed abdominal wound healing, seroma)
Time frame: In the 6-week follow-up period
Interventions for complications
Number of interventions required to deal with complication for each patient (for example needle aspiration, surgery, iv antibiotics)
Time frame: In the 6-week follow-up period
Seroma presence on abdominal ultrasound
Abdominal ultrasound to identify
Time frame: At the 2- and 6-week follow-up appointments
Size of seroma collection on abdominal ultrasound
Size (length, width and depth was measured and used to estimate the size using the formula of half an ellipse)
Time frame: At the 2- and 6-week follow-up appointments
Plan to share: No — There is no plan to share the IPD
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Anglia Ruskin University