title: Alleviation of chronic venous leg ulcers with a hand-held dielectric barrier discharge plasma generator (PlasmaDerm(®) VU-2010): results of a monocentric, two-armed, open, prospective, randomized and controlled trial (NCT01415622).
abstract: BACKGROUND
  Cold atmospheric plasma (CAP, i.e. ionized air) is an innovating promising tool in reducing bacteria.
  
  
  OBJECTIVE
  We conducted the first clinical trial with the novel PlasmaDerm® VU-2010 device to assess safety and, as secondary endpoints, efficacy and applicability of 45 s/cm(2) cold atmospheric plasma as add-on therapy against chronic venous leg ulcers.
  
  
  METHODS
  From April 2011 to April 2012, 14 patients were randomized to receive standardized modern wound care (n = 7) or plasma in addition to standard care (n = 7) 3× per week for 8 weeks. The ulcer size was determined weekly (Visitrak® , photodocumentation). Bacterial load (bacterial swabs, contact agar plates) and pain during and between treatments (visual analogue scales) were assessed. Patients and doctors rated the applicability of plasma (questionnaires).
  
  
  RESULTS
  The plasma treatment was safe with 2 SAEs and 77 AEs approximately equally distributed among both groups (P = 0.77 and P = 1.0, Fisher's exact test). Two AEs probably related to plasma. Plasma treatment resulted in a significant reduction in lesional bacterial load (P = 0.04, Wilcoxon signed-rank test). A more than 50% ulcer size reduction was noted in 5/7 and 4/7 patients in the standard and plasma groups, respectively, and a greater size reduction occurred in the plasma group (plasma -5.3 cm(2) , standard: -3.4 cm(2) ) (non-significant, P = 0.42, log-rank test). The only ulcer that closed after 7 weeks received plasma. Patients in the plasma group quoted less pain compared to the control group. The plasma applicability was not rated inferior to standard wound care (P = 0.94, Wilcoxon-Mann-Whitney test). Physicians would recommend (P = 0.06, Wilcoxon-Mann-Whitney test) or repeat (P = 0.08, Wilcoxon-Mann-Whitney test) plasma treatment by trend.
  
  
  CONCLUSIONS
  Cold atmospheric plasma displays favourable antibacterial effects. We demonstrated that plasma treatment with the PlasmaDerm® VU-2010 device is safe and effective in patients with chronic venous leg ulcers. Thus, larger controlled trials and the development of devices with larger application surfaces are warranted.
authors.affiliation: Department of Dermatology, Venereology and Allergology, University Medical Center Göttingen, Göttingen, Germany.
authors.forename: F
authors.initials: F
authors.lastname: Brehmer
authors.forename: H A
authors.initials: HA
authors.lastname: Haenssle
authors.forename: G
authors.initials: G
authors.lastname: Daeschlein
authors.forename: R
authors.initials: R
authors.lastname: Ahmed
authors.forename: S
authors.initials: S
authors.lastname: Pfeiffer
authors.forename: A
authors.initials: A
authors.lastname: Görlitz
authors.forename: D
authors.initials: D
authors.lastname: Simon
authors.forename: M P
authors.initials: MP
authors.lastname: Schön
authors.forename: D
authors.initials: D
authors.lastname: Wandke
authors.forename: S
authors.initials: S
authors.lastname: Emmert
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001291:Attitude of Health Personnel; D058491:Bacterial Load; D002908:Chronic Disease; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000209:etiology; D010147:Pain Measurement / Q000379:methods; D010865:Pilot Projects; D058626:Plasma Gases / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D014647:Varicose Ulcer / Q000150:complications / Q000382:microbiology* / Q000628:therapy*
chemical_list: D058626:Plasma Gases