Landscheidt Kristina, Alabdulmohsen Ahmed, Hübscher Markus, Geber Benjamin, Hernekamp Jochen-Frederick, Goertz Ole
Department of Plastic, Reconstructive and Aesthetic Surgery, Hand Surgery Martin-Luther Hospital (Martin-Luther Krankenhaus) Berlin Germany.
STORZ Medical AG Tägerwilen Switzerland.
Health Sci Rep. 2025 Jan 8;8(1):e70311. doi: 10.1002/hsr2.70311. eCollection 2025 Jan.
The aim of our prospective blinded 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, several secondary parameters were investigated to evaluate the compatibility of the therapeutic method, its influence on infection occurrence and bacterial colonization.
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 Day 0 after surgical treatment and on Days 5, 7, 9, and 12 after surgery. To record long-term results, an additional evaluation of the wound situation was performed on Day 90.
Epithelialization was statistically significantly accelerated by shock wave application at both skin graft recipient sites and donor sites (0.86 vs. 0.92, < 0.05). Furthermore, the risk of wound infection was significantly reduced by using extracorporeal shock waves. Serious side effects were not reported.
A repeated application of ESWT followed by standardized wound care was shown to significantly accelerate the time to re-epithelialization at the skin graft donor and recipient site compared with re-epithelialization time in patients of the sham/placebo group.
我们这项前瞻性双盲临床研究的目的是，研究低能量体外冲击波治疗对慢性伤口患者皮肤移植供体和受体部位上皮化的可能改善及加速作用。此外，还研究了几个次要参数，以评估该治疗方法的兼容性、其对感染发生和细菌定植的影响。
共有35例患者纳入本研究。其中，25名参与者被分配到真-安慰剂组，10名被分配到假治疗组。设置假手术对照组的研究是为了排除安慰剂区域可能存在的“远程效应”。根据分组情况，伤口区域分别接受低频冲击波、安慰剂或假治疗。在手术治疗后的第0天以及术后第5、7、9和12天立即进行检查。为记录长期结果，在第90天对伤口情况进行了额外评估。
在皮肤移植受体部位和供体部位应用冲击波后，上皮化在统计学上有显著加速（0.86对0.92，P<0.05）。此外，使用体外冲击波可显著降低伤口感染风险。未报告严重副作用。
与假手术/安慰剂组患者的上皮化时间相比，重复应用体外冲击波疗法并结合标准化伤口护理，可显著加速皮肤移植供体和受体部位的再上皮化时间。
