Clinical Relevance of the Antimicrobial Resistance Testing in the Treatment of Chronic Wounds With Antiseptics
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Change in bacteria rate
研究概览
简要总结
The study objective is to improve the current and local standard antiseptic treatment by adjusting the antiseptic agent to the antimicrobial resistance testing result, accordingly. Currently, resistance testing will only be performed for the treatment with antibiotics.
详细描述
Complications like bacterial wound colonization and infections in wound treatment are still a serious problem. Several therapy approaches are available to treat these complications, e.g. surgical wound debridement, antimicrobial therapy that can be divided into a local and a systemic antisepsis.
The local antisepsis (the local utilization of antiseptics directly to the wound) is in many ways advantageous to the systemic antisepsis (orally or intravenously administered antibiotics): e. g. the direct contact of the antiseptic to the bacteria at the site of infection whereas antibiotics may not sufficiently reach the wound due to limited blood perfusion of wounds; growing utilization of systemic antisepsis also leads to an increasing number of resistant bacteria worldwide. To the concerns of many specialists, the first pan-resistant bacterial strain which is resistant to all available antibiotics including colistin was recently published.
In future, the role of local antisepsis therefore becomes more important in the antimicrobial treatment. Luckily, resistances of local antiseptics occur slowly due to the chemical and structural characteristics of antiseptics but even resistances of bacteria to antiseptics were reported. Unlike the antimicrobial resistance testing for antibiotics that is done in the clinical routine, such testing is not a standard procedure for antiseptics for no obvious reason. The utilization of antiseptics is determined by the availability of products provided within the institution and preferences of the clinician. Thus, it is unknown whether the chosen antiseptic has any bactericidal effect on the confirmed bacteria.
University Hospital RWTH Aachen Wound Care only uses polyhexanide and octenisept. Iodine-containing preparations are explicitly not desired.Improvement (bacteria reduction, acceleration of wound healing) of the local antiseptic therapy by adapting the antiseptic to the results of antimicrobial resistance testing. Antimicrobial resistance testing has so far only been used to adapt systemic antibiotic therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Decubitus OR secondary healing acute and chronic wounds
- •Positively tested wound swab for bacteria (incl. multi-resistant bacteria)
- •Patient is capable of understanding the nature, significance and consequence of the clinical trial
- •Given written consent
- •Women of child bearing potential (WOCBP) who apply appropriate methods of contraception throughout the duration of the study
排除标准
- •Occlusive dressing (e.g. VAC) or Negative Pressure Wound Therapy (NPWT)
- •Pregnant or lactating women
- •Known allergies against investigational products
研究组 & 干预措施
Resistance testing
Patients will be first tested on resistance to Octenisept and Serasept and will receive the appropriate antiseptic after reviewing the results
干预措施: Octenisept and Serasept (Drug)
结局指标
主要结局
Change in bacteria rate
时间窗: up to 12 months
determination of the relative proportion of isolates to the total flora in the wound
次要结局
- Laboratory Parameters - Change in C-reactive protein (CRP)(up to 12 months)
- Laboratory Parameters - Change in Leukocytes(up to 12 months)
- Change in Bates-Jensen Score(up to 12 months)
- Incidence of wound related adverse events(up to 12 months)
- Change in Pressure Ulcers: Scale for Healing (PUSH) score(up to 12 months)
- Laboratory Parameters - Change in hemoglobin(up to 12 months)
- Laboratory Parameters - Change in hematokrit(up to 12 months)
- Laboratory Parameters - Change in creatinine(up to 12 months)
- Laboratory Parameters - Change in glomerular filtration rate (GFR)(up to 12 months)
- Laboratory Parameters - Change in Uric acid(up to 12 months)
- Laboratory Parameters - Change in glutamic-pyruvic transaminase (GPT)(up to 12 months)
- Laboratory Parameters - Change in Glutamat-Oxalacetat- Transaminase (GOT)(up to 12 months)
- Laboratory Parameters - Change in Glucose(up to 12 months)
- Hospital length of stay(up to 12 months)
- Rate of antibiotics used(up to 12 months)
- Length of bed confinement(up to 12 months)