The Efficacy of Low-Temperature Atmospheric-Pressure Plasma (LTAPP) in the Multicenter Treatment of Pressure Ulcers: A Randomized Controlled Trial.

Abstract

IntroductionThis study is to examine the reduction in wound size between the LTAPP and the control group and also investigate the wound healing effect factor.MethodsA randomized controlled trial was conducted at five study centers. Participated patients were between 18-80 years old who had pressure ulcer wound(s) and excluded patients with high risk or receiving other treatment such as previous radiation therapy in the affected area, pregnancy, sepsis, and immunocompromised host. The study divided participant into LTAPP group and standard of care (SOC) group, the LTAPP group would received a dressing of non-Ag materials and administer LTAPP for 1 min per 1 cm² (maximum of 20 min). The SOC group would received standard dressing wound protocol. Both groups would be followed until the end of study (ninth visit) or until the wound healed.ResultsWhen considering patients who attended follow-up ≥4 visits, only 45 ulcers were eligible, of which consisted of 21 ulcers in the LTAPP group and 24 ulcers in the SOC group. The results showed significant healing rate of the LTAPP group, whether to be the wound size: wound area and wound volume, wound healing: exudate reduction, granulation and lesser necrotic tissue or Pressure Ulcer Scale for Healing (PUSH) score. The LTAPP group had better bacterial load reduction without the use of tropical antibiotic, this also signified the quality in bacterial eradication of LTAPP.ConclusionLTAPP showed outstanding performance in treating pressure ulcer wounds. The LTAPP gave greater outcome in wound size, wound healing indicators, microbiological analyses and cost-effective comparison. Although, the absence of statistical significance, it did not affect the outcome trends. This study suggested further investigation of the potential role of LTAPP therapy in different wound types in near future.