Monocentric, prospective randomizedclinical study to examine the results of shock waves on healing of wounds in a standardized wound model and after split skin grafting

Status:

completed 12/2019

Aims:

The aim of our prospective clinical study was to examine a possible improvement and acceleration of epithelialization by treatment with low-energy extracorporeal shock waves on skin graft donor and recipient sites in patients with chronic wounds. In addition, a number of secondary parameters were investigated to evaluate the compatibility of the therapeutic method, its influence on infection incidence and bacterial colonization.

Activities/Methods:

A total of 35 patients were included in the study. Of these, 25 participants were assigned to the verum-placebo group and 10 to the sham treatment group. The study of the sham control group was done to exclude a possible "remote effect" of the placebo area. Depending on the group, the wound areas were treated with low-frequency shock waves, placebo or sham. The examinations were performed immediately on d0 after surgical treatment and on days 5, 7, 9, and 12 after surgery. For the purpose of recording long-term results, an additional evaluation of the wound situation was performed at day 90.

Results:

Epithelialization was statistically significantly accelerated by shock wave application at both skin graft recipient sites and donor sites (0.86 vs. 0.92, p=0.049). The risk of wound infection was significantly reduced. Serious adverse effects were not reported.

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