A Multicenter, Prospective, Randomised Controlled Trial to Compare the Pressurized Irrigation Method With Conventional Practice of Swabbing for Wound Cleansing
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 256
- 试验地点
- 1
- 主要终点
- time-to-wound healing
研究概览
简要总结
The study is to examine the effectiveness of cleansing wound with pressurized irrigation method compared with conventional practice of swabbing on the wound healing and infection of acute and chronic wound, and to evaluate the patient's physical symptoms related to wound, patient's satisfaction to cleansing method, and cost of materials used between the two groups.
Patients with acute or chronic non-sutured wounds as well as being eligible to exclusion criteria will be recruited and randomly assigned to be cleansed using either: pressurized irrigation method (experimental group) or swabbing method (control group).
244 patients will be recruited in the study. This will take place in four community health centres run by the Hospital Authority in Hong Kong. The wounds of participants will be cleansed using the assigned method for a six week period. The clinic staff nurse is responsible for the ongoing assessment of the wound.
Wound assessment will be undertaken at enrolment and upon healing of the wound or at the end of six-week period if the wounds have not healed. Demographic data and information related to the wound -wound size +/- wound volume, wound culture swab, and symptoms -wound discomfort, pain and odour will be collected at enrolment. Information related to the wound and subjective measures of patient satisfaction -feeling of cleanliness, liking, and of staff satisfaction -feeling user-friendliness, accessibility, cleanliness, liking to the cleansing method using VAS will be assessed at completion of treatment. A list of cost measurements for the wound cleansing would also be captured.
详细描述
- Registration/ randomization procedure:
Once patients are identified as potential participants at their outpatient clinic visit, the research nurse will initiate the enrolment process by explaining the objectives of the proposed study to the patient. Informed consents are obtained for eligible subjects. A thorough assessment and measurement of the wound will be done by another research nurse. Participants are asked to complete the first questionnaire. Participants are then randomized to either intervention or control group. Randomization will be done by a randomization list generated by a statistician using a simple randomization method and programmed in a designated computer.
- Schema of intervention delivery and data collection:
The wounds of participants in control group and study group will be cleansed following to the allocated method until the wounds are completely healed or for six weeks if the wounds have not yet healed. Wound-care specialists and microbiologists will be consulted throughout the study for technical advice, particularly on information not readily available in the literature. Decisions relating to the time period needed to detect wound infection and healing, as well as the investigations required to detect wound infection, are made in consultation with this group.
The first research nurse will undertake wound cleansing for experimental group. Wound cleansing in control group is done as usual by the staff nurses in the four designated clinics, who will attend an education programme which explains the details of the study, the procedures to be followed, and the patient documentation. The first research nurse and the clinic nurse who undertakes dressing change are responsible for the ongoing assessment of the wound during cleansing and recording the information on the volume of solution and amount of cleansing materials used, frequency of dressing changes and the type of dressing applied at each visit. Participants are instructed to report any signs of infection to the first research nurse and the clinic nurse or physician. The second research nurse who is blinded to the wound cleansing method will undertake data collection and wound assessment for all subjects at enrollment and upon healing of the wound or at the end of six-week period if the wounds have not yet healed. Wounds that have not healed at the end of the six-week period will be reassessed and data relating to the wound characteristics are recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 14 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Had wounds to be healed by secondary intention,
- •could speak Chinese,
- •with an abbreviated mental test score 7 or above indicating their normal cognitive ability; and
- •being able to be accessible for wound cleansing and evaluation follow up.
排除标准
- •Unbroken skin;
- •Full-thickness skin loss and damage to muscle, bone or/and any supporting structures (e.g. tendon, joint capsule);
- •Wounds with a sinus where the base of the wound is not visible;
- •Wounds to be healed by primary intention (e.g. sutured wound, skin grafts and skin-graft donor sites);
- •Wound that was prescribed to be cleansed by irrigation;
- •Patient with more than one wound;
- •Patients with a very poor life expectancy or with a clinical condition that might interfere with wound healing such as active carcinoma, vasculitis, use of systemic corticosteroids, immunosuppressive agents, radiation therapy or chemotherapy within the past 30 days.
结局指标
主要结局
time-to-wound healing
时间窗: during the follow up within six-week period if the wounds have not yet healed
Complete healing is defined as complete coverage of the wound with epithelial tissue. Patient's wound that was observed to completely heal was referred for a wound check by second research nurse who was blinded to the intervention method. Healing time was indicated by number of days before complete skin integrity returned.
次要结局
- infection rate during follow up(During follow up within six-week period if the wounds have not yet healed)
研究者
Suzanne So-Shan Mak
Ms
Prince of Wales Hospital, Shatin, Hong Kong