Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Breast Reconstruction | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Conventional diathermy | Device | — | UNRESOLVED |
| PEAK PlasmaBlade™ | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Conventional diathermy
- description
- DIEP/ MS-TRAM breast reconstruction free flap raise performed with conventional diathermy
- interventionNames
- Device: Conventional diathermy
- type
- EXPERIMENTAL
- label
- PEAK PlasmaBlade™
- description
- DIEP/ MS-TRAM breast reconstruction free flap raise performed with PEAK PlasmaBlade™
- interventionNames
- Device: PEAK PlasmaBlade™
Primary outcomes (1)
- measure
- Number of days the abdominal drains were required
- timeFrame
- Drain requirement from the day of operation (day 0) until the day the drain was removed when producing 30ml or less/ 24 hours
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (5)
- BACKGROUNDMassarweh 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
- BACKGROUNDYilmaz 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
- BACKGROUNDLoh 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
- BACKGROUNDRuidiaz 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
- BACKGROUNDDogan 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