Evidence Supporting Extracorporeal Shockwave Therapy for Acute and Chronic Soft Tissue Wounds
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Patients were randomly assigned to receive standard topical therapy (nonadherent silicone mesh [Mepitel®, Mölnlycke Health Care, Norcross, GA] and antiseptic gel [polyhexanide/octenidine]) to graft donor sites with (n = 13) or without (n = 15) defocused, low energy ESWT (100 impulses/cm2 at 0.1 mJ/mm2) applied once to the donor site immediately after skin harvest. Independent blinded observers determined the primary endpoint, which was time to complete epithelialization. The ESWT-treated group had a significantly (P = 0.0001) shorter time to complete epithelialization (13.9 ± 2.0 days) compared to controls, which received only standard dressings (16.7 ± 2.0 days).
The effects of ESWT in a severe full-thickness burn injury was also investigated in an animal model, showing ESWT-related attenuation of both CC- and CXC-chemokine expression, acute pro-inflammatory cytokine expression, and extracellular matrix proteolytic activity at the burn wound margin.18 In the wound area, excessive inflammatory responses involving increased levels of inflammatory cells, pro-inflammatory cytokines, and proteases may be attenuated with ESWT allowing wound healing to progress by way of normal physiological repair processes.19
In 2010, the results of a clinical trial evaluating the effects of ESWT on deep partial- and full-thickness burns in 15 patients with < 5% of total body surface area burns were published. Arno et al42 evaluated burn area perfusion with Laser Doppler Imaging system and reported that all burns had significantly increased perfusion after ESWT treatment. The authors also reported that in less than 3 weeks 80% healed completely, 15% required surgical debridement, and 5% developed hypertrophic scarring. Their findings suggest that ESWT may decrease the need for surgical intervention and associated morbidities in patients with severely deep partial- or full-thickness burns.
Together with these findings, and given its proven clinical success, ESWT was further studied in a prospective Phase II clinical trial of 50 patients with second degree burns randomly assigned to standard burn wound care with or without ESWT from December 2006 to December 2007.42 The control group received burn wound debridement/topical antiseptic therapy. The intervention group, in addition to the same standard therapy, also received low energy, defocused ESWT (100 impulses/cm² at 0.1 mJ/mm², ~20 seconds/cm2) applied as a single treatment within 24 hours of superficial second degree burn wound debridement. The primary endpoint, time to complete burn wound epithelialization, was determined by an independent, blinded observer. Mean time to complete burn wound epithelialization in the ESWT-treated group was significantly (P < 0.0005) shorter than in controls, 9.6 ± 1.7 versus 12.5 ± 2.2 days, respectively.
Studies of ESWT for Chronic Soft Tissue Indications
In 2008, Saggini et al43 conducted a preliminary study to investigate the feasibility of ESWT in the treatment of lower extremity chronic ulcers. They enrolled 40 consecutive patients (30 assigned to receive ESWT in addition to conservative dressings and 10 as control group treated with standard dressings only). A total of 32 wounds were treated with ESWT and 16 healed during the 6 treatment period. The other 50% that did not heal showed significant decrease of wound size, and amount of exudates associated with ESWT. Formation of granulation tissue was also significantly more abundant in the shockwave-treated group compared with controls.