Auswirkung der Cell Information Therapy (CIT) auf die Wundheilung von Spalthautentahmestellen anhand einer randomisierten, prospektiven, placebokontrollierten Doppelblind-Studie

Every day patients and their doctors have a great interest in fast wound healing, whether the injuries are accidental or a result of plastic surgery. In the complex process of wound healing, there are many different factors that can fasten or slow down the healing. Besides wound infections two of the most common complications of wound healing are Diabetes mellitus and vascular diseases. This is especially important for older patients. Therefore there is a great deal of interest for a fast and uncomplicated healing method to decrease the length of the healing process. A lot of published data implies that extreme low frequency electromagnetic fields (ELF-EMF) can achieve this task. Out of many different therapeutic methods being on the market, the Cell Information Therapy (CIT) is the one to be tested in this study, because of its high usage in many dermatological doctors’ offices or in naturopathy. The Somagen® master, developed and built by the Sachtleben GmbH, is the therapy device, which uses a pulsed ELF-EMF to increase wound healing. The aim of this clinical trial was to investigate the effect of CIT on wound healing in a randomized, prospective and placebo-controlled double-blind study, which was also stratified for Diabetes mellitus. The effectiveness of CIT was tested on split-thickness skin graft donor sites, which are very useful for clinical studies because of their uniform structure and their easy repeatability. The primary end point was the “time until complete wound healing”, measured in days from surgery to losing the scab. The secondary end points were the “size of the hemorrhagic scab” and the “quality of the wound base”. The former was measured in percentage of the whole wound surface. The latter was used to reveal, whether the wound base was erosive or not. There were two groups. The therapy group was treated with standard wound therapy consisting of Mepithel® and Aureomycin® and the Somagen® Master. The device was used for 10 days in a standardized therapeutic process. The patient was treated for 20 or 30 minutes every day (depending on the treatment mode). The first treatment session took place at the day of surgery. The control group was treated the same way, but with a placebo-device instead of the real one. 53 patients were recruited, randomized and treated in this clinical study. 50 patients were included into the assessment at the end, thus 25 patients per group. The results showed no significant differences between the two groups in all end points. The primary end point was 25.6 days in therapy group and 23.8 days in control group. The “size of the hemorrhagic scab” was 11.3% in therapy group and 14.3% in control group. 10 patients in therapy group (50.0%) and 11 in control group (57.9%) had an erosive wound base. The stratification for Diabetes mellitus had no influence on the results. In therapy group two patients discontinued the treatment for personal reasons. In control group the treatment had to be cancelled two times: One was a defect of the therapy device and the other one was a violation of the treatment protocol. Three patients were excluded from the beginning, because they met one of the exclusion criteria. No side effects appeared during the treatment. To conclude, the CIT does not measurably affect the healing of split-thickness skin graft donor sites. Taking the absolute time until complete wound healing into consideration the therapy with the Somagen® Master took two days more than placebo. Therefore the use of the CIT to treat a split-thickness skin graft donor site cannot be recommended on basis of these results. However due to the small study groups an effect cannot be ruled out completely. Therefore further randomized clinical trials with a larger sample are needed to verify this statement.