NCT04350411 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

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.
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.
Massarweh NN, Cosgriff N, Slakey DP
Electrosurgery: history, principles, and current and future uses. J Am Coll Surg. 2006 Mar;202(3):520-30.
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.
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.

Comparison of PEAK PlasmaBlade™ to Conventional Diathermy in Abdominal Based Free Flap Breast Reconstruction - a Single Centre, Double Blinded Randomised Controlled Trial

Details for clinical trial NCT04350411

Clinical trial NCT04350411 - References