Effectiveness of Extracorporeal Shockwave Therapy in Patients With Chronic Wounds Hospitalized in a Medium Stay Hospital
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Decrease wound size area
研究概览
简要总结
Introduction: Chronic wounds are a major health problem with impact in the quality of life of patients, increased their morbidity and mortality, nursing burden, extend the hospital stays, and healthcare costs. Searching how to apply the best care available in wounds, shock wave treatment is found in order to stimulate tissue growth in this type of skin injuries. There are different studies to support this recommendation but also there is variability about of patients, different types of injuries or settings. It is considered that more research studies are needed to maintain this evidence and to explore other settings like the effectiveness in a medium stay hospital.
Objectives: To assess the effectiveness of shockwave treatment to reduce the size of chronic wounds.
Method: A quasi-experimental design will be used. The population under study will include patients admitted in the Functional Recovery Unit who present chronic wounds upon admission. The sample size will be 30 patients. An intentional non-probabilistic sampling will be carried out. Main outcome: decrease the wound size. Sociodemographic variables, personal history, comorbidities, current clinical situation, shock wave treatment variables and its evolution will be collected.
Applicability: In case of findings are better than habitually care, the number of treatments required by the patient would be reduced, the patient's state of health would improve, the risk of infection of the wound decrease, and the comfort and quality of life of patients could improve. The findings may represent a change in clinical practice because they may be used to modify the treatment protocols for chronic wounds at the Guadarrama Hospital and in other similar hospitals. Also, they can contribute to the evidence based care which supports shockwave treatment.
详细描述
Recruitment: the research team will recruit participants who meet inclusion criteria and do not present exclusion criteria, during the first 48 hours of admission to the functional recovery unit. A member of the team will inform and invite the subject or his or her legal representative to participate in the study. The information sheet will be given to the patient and after accepting, he/she has to sign the specific informed consent for the study and the authorization to take images. At that time, the completion of the Data Collection Notebook will begin, which has been prepared ad hoc by the research team. In order to guarantee the confidentiality of the personal data, they will be coded by dissociating the identifying and personal data from those necessary for the configuration of variables. To this end, the personal identity carry out a coding process of the units of analysis. In the event that the same patient has more than one wound that can be included in the study, a data collection notebook will be used for each wound, indicating its location and using the same coding, because the coding number will be associated with each patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Patient aged 18 years or older,
- •To have a chronic wound classified as:
- •pressure ulcer,
- •ischemic wounds,
- •neuropathic wounds,
- •dehiscence of surgical wounds
- •delayed current of wound healing of more than 6 weeks.
- •To sign informed consent.
- •Exclusion criteria:
- •To have signs of infection observed in wound.
- •Necrotic tissue.
- •Tumor wounds.
- •Venous thrombosis.
- •Large blood vessels at lesion edges.
排除标准
- 未提供
结局指标
主要结局
Decrease wound size area
时间窗: All wounds will be measured at the end of the intervention (3 weeks).
Decrease de size area at the end of the intervention. The surface of the wound will be measured in centimeters (length x width)
次要结局
- To quantify the change in the size of chronic wounds treated with shock waves(at the end of the intervention (3 weeks))
- To assess whether the pain perception due to chronic wounds in patients undergoing the intervention decreases. The pain perception will be measured with Visual Analogue Scale (VAS) or Pain Assesment in Advanced Dementia Scale (PAINAD).(Baseline and during the intervention (up 3 weeks))
- To identify the patients variables related to achieve a lesion reduction equal to or greater than 50% of the surface measured in centimeters (greater success in healing).(at the end of the intervention (3 weeks))
- To assess number and types of side effects what patients shows related to the use of low-frequency shockwaves in chronic wounds.(at the end of the intervention (3 weeks))
研究者
Laura Martín Losada
Nurse Director
Guadarrama Hospital