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Prospective Randomized Phase II Trial of Accelerated Reepithelialization of Superficial Second-Degree Burn Wounds Using Extracorporeal Shock Wave Therapy

Ottomann, Christian MD*; Stojadinovic, Alexander MD, FACS†,‡; Lavin, Philip T. PhD§; Gannon, Francis H. MD; Heggeness, Michael H. MD; Thiele, Richard MD; Schaden, Wolfgang MD**; Hartmann, Bernd MD*

doi: 10.1097/SLA.0b013e318227b3c0
Randomized Clinical Trials

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/cm2 at 0.1 mJ/mm2) 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).

A randomized phase II trial showed that a single therapeutic application of shock waves to a superficial second-degree burn wound after debridement significantly accelerates reepithelialization compared to controls (mean time to complete epithelialization: 9.6 ± 1.7 and 12.5 ± 2.2 days, respectively; P < 0.0005).

*Unfallkrankenhaus Berlin, Zentrum für Schwerbrandverletzte mit Plastischer Chirurgie, Berlin, Germany

Combat Wound Initiative Program, Rockville, MD

Department of Surgery, Uniformed Services University of the Health Sciences, Bethesda, MD

§Boston Biostatistics Research Foundation, Framingham, MA

Baylor College of Medicine, Houston, TX

Internationales Zentrum für Stosswellentherapie, Berlin, Germany

**AUVA-Trauma Center Meidling, Vienna, Austria.

Reprints: Christian Ottoman, MD, Unfallkrankenhaus Berlin, Zentrum für Schwerbrandverletzte mit Plastischer Chirurgie, Berlin, Germany. E-mail: christian.ottoman@ukb.de.

Disclosure: Professor Schaden owns stock and is a board member of Tissue Regeneration Technologies LLC. Dr Richard Thiele owns stock in Tissue Regeneration Technologies LLC, and was a former Scientific Advisor to the Company. Supported, in part, by the Congressionally directed Combat Wound Initiative Program, and the Internationales Zentrum für Stosswellentherapie, Berlin, Germany. The shockwave device used in this trial is an investigational device currently used in TRT LLC-sponsored FDA trials under the trade name DermaGold.

The views expressed in this presentation are those of the authors and do not reflect the official policy of the Department of the Army, the Department of Defense, or the United States Government.

All study patients were enrolled in an IRB-approved clinical trial at Unfallkrankenhaus Berlin, Zentrum für Schwerbrandverletzte mit Plastischer Chirurgie, Berlin, Germany.

© 2012 Lippincott Williams & Wilkins, Inc.