title: Prospective randomized phase II Trial of accelerated reepithelialization of superficial second-degree burn wounds using extracorporeal shock wave therapy.
abstract: BACKGROUND
  As extracorporeal shock wave therapy (ESWT) can enhance healing of skin graft donor sites, this study focused on shock wave effects in burn wounds.
  
  
  METHODS
  A predefined cohort of 50 patients (6 with incomplete data or lost to follow-up) with acute second-degree burns from a larger study of 100 patients were randomly assigned between December 2006 and December 2007 to receive standard therapy (burn wound debridement/topical antiseptic therapy) with (n = 22) or without (n = 22) defocused ESWT (100 impulses/cm at 0.1 mJ/mm) applied once to the study burn, after debridement. Randomization sequence was computer-generated, and patients were blinded to treatment allocation. The primary endpoint, time to complete burn wound epithelialization, was determined by independent, blinded-observer. A worst case scenario was applied to the missing cases to rule out the impact of withdrawal bias.
  
  
  RESULTS
  Patient characteristics across the 2 study groups were balanced (P > 0.05) except for older age (53 ± 17 vs. 38 ± 13 years, P = 0.002) in the ESWT group. Mean time to complete (≥95%) epithelialization (CE) for patients that did and did not undergo ESWT was 9.6 ± 1.7 and 12.5 ± 2.2 days, respectively (P < 0.0005). When age (continuous variable) and treatment group (binary) were examined in a linear regression model to control the baseline age imbalance, time to CE, age was not significant (P = 0.33) and treatment group retained significance (P < 0.0005). Statistical significance (P = 0.001) was retained when ESWT cases with missing follow-up were assigned the longest time to CE and when controls with missing follow-up were assigned the shortest time to CE.
  
  
  CONCLUSIONS
  In this randomized phase II study, application of a single defocused shock wave treatment to the superficial second-degree burn wound after debridement/topical antiseptic therapy significantly accelerated epithelialization. This finding warrants confirmation in a larger phase III trial (ClinicalTrials.gov identifier: NCT01242423).
authors.affiliation: Unfallkrankenhaus Berlin, Zentrum für Schwerbrandverletzte mit Plastischer Chirurgie, Berlin, Germany. christian.ottoman@ukb.de
authors.forename: Christian
authors.initials: C
authors.lastname: Ottomann
authors.forename: Alexander
authors.initials: A
authors.lastname: Stojadinovic
authors.forename: Philip T
authors.initials: PT
authors.lastname: Lavin
authors.forename: Francis H
authors.initials: FH
authors.lastname: Gannon
authors.forename: Michael H
authors.initials: MH
authors.lastname: Heggeness
authors.forename: Richard
authors.initials: R
authors.lastname: Thiele
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Schaden
authors.forename: Bernd
authors.initials: B
authors.lastname: Hartmann
mesh_terms: D000328:Adult; D000368:Aged; D000891:Anti-Infective Agents, Local / Q000627:therapeutic use; D001645:Biguanides / Q000627:therapeutic use; D002056:Burns / Q000503:physiopathology / Q000628:therapy*; D015331:Cohort Studies; D003646:Debridement; D005260:Female; D005858:Germany; D006801:Humans; D007097:Imines; D008297:Male; D008875:Middle Aged; D011725:Pyridines; D014464:Ultrasonic Therapy / Q000379:methods*; D014945:Wound Healing / Q000187:drug effects / Q000502:physiology*
chemical_list: D000891:Anti-Infective Agents, Local; D001645:Biguanides; D007097:Imines; D011725:Pyridines; C031233:polihexanide; C034213:octenidine