Breast Cancer Clinical Trial
Official title:
Comparison of PEAK PlasmaBlade™ to Conventional Diathermy in Abdominal Based Free Flap Breast Reconstruction - a Single Centre, Double Blinded Randomised Controlled Trial
NCT number | NCT04350411 |
Other study ID # | 16/17 086 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 31, 2016 |
Est. completion date | May 31, 2018 |
Verified date | April 2020 |
Source | Anglia Ruskin University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 108 |
Est. completion date | May 31, 2018 |
Est. primary completion date | April 24, 2018 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 80 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Mid Essex NHS trust | Chelmsford | Essex |
Lead Sponsor | Collaborator |
---|---|
Anglia Ruskin University | Medtronic, Mid Essex Hospital NHS Trust |
United Kingdom,
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. — View Citation
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):1849-59. doi: 10.1097/PRS.0b013e3181bcee87. — View Citation
Massarweh NN, Cosgriff N, Slakey DP. Electrosurgery: history, principles, and current and future uses. J Am Coll Surg. 2006 Mar;202(3):520-30. — View Citation
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):104-11. doi: 10.1097/PRS.0b013e31821741ed. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Flap raise time | Time required to raise abdominal flap (minutes) | Data recorded during operation | |
Secondary | Weight of abdominal flap | Weight of raised abdominal flap in grams | Data recorded during operation | |
Secondary | 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 | Drain fluid on day 0, 1 and 2 | |
Secondary | Pain score | 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) | |
Secondary | Mobility | Number of steps a day | While an inpatient (between 3 - 14 days) | |
Secondary | Total abdominal drain fluid output | 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) | |
Secondary | Complications | 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 | |
Secondary | Interventions for complications | 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 | |
Secondary | Seroma presence on abdominal ultrasound | Abdominal ultrasound to identify | At the 2- and 6-week follow-up appointments | |
Secondary | 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) | At the 2- and 6-week follow-up appointments |
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