Clinical and Economic Effectiveness of Testing Chronic Wounds for BPA (Bacterial Protease Activity) Using WOUNDCHEK Bacterial Status: A Pragmatic Randomised Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Mean wound area percent change
研究概览
简要总结
100 chronic wounds asymptomatic for infection that test positive for bacterial protease activity (BPA) on initial screening (approx 250 wounds in total to be tested) will be randomized to intervention or control. 50 patients will receive intervention (silver antimicrobial dressing) in addition to standard care and 50 will receive standard care only (control). Wound healing at 12 weeks will be compared in addition to costs, patient quality of life, referrals to secondary care, surgical interventions, rates of infection and antibiotic use.
详细描述
A prospective, open randomized controlled study in the community setting. Study participants will be selected from chronic wound patients being treated in the community by Pennine Care NHS Foundation Trust that are not considered to be infected and are not currently being treated with a topical antiseptic dressing. Patients diagnosed with a chronic wound and determined to meet the study inclusion criteria can be enrolled after informed consent. Only one wound is allowed per patient (defined as the 'index wound). If a patient has multiple wounds, the largest wound will be selected.
Enrolled patients will be tested for BPA using the WOUNDCHEK™ Bacterial Status. Patients with negative results will take no further part in the study. Patients with positive results, will be randomized into either the Intervention or the Control arm of the study.
The study aims to enrol 100 patients that test positive for BPA. An expected prevalence of between 40 and 50 percent BPA positive means that between approximately 200 and 250 patients will need to be enrolled and screened to reach the target number of 100 BPA positive wounds.
A total of up to 100 patients with a chronic wound that test positive for BPA during screening will be randomized to receive either a silver antimicrobial dressing appropriate for the wound exudate level for 2 weeks +/- 3 days, in addition to any other standard care requirements (e.g. compression) (Intervention arm) or receive standard care only (Control arm).
The patients will be followed up at 12 weeks post enrolment or within two weeks of wound closure (whichever is earliest). The Research Nurse will visit the patient to measure the wound size or determine if the wound has healed and complete the EQ5D-5L questionnaire.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- •Ability to give informed consent
- •Competence with English language
- •Subject has a chronic wound (venous, arterial and mixed etiology leg ulcers, diabetic foot ulcers and pressure ulcers), >1cm2 area which is not showing symptoms of infection or spreading cellulitis / lymphadenitis / lymphangitis and is not receiving treatment for local or systemic infection due to the wound.
- •Subject is 18 years of age or older.
- •Women must be of non-childbearing potential.
- •The wound is more than 4 weeks old.
排除标准
- •Women who are pregnant/planning a pregnancy or breastfeeding
- •The wound area is ≤1cm
- •The wound is obviously infected as defined by the Pennine Care Wound Management Formulary or is receiving treatment for local or systemic infection.
- •The wound has been diagnosed as being malignant.
- •Subject has hypersensitivity of the wound or painful wound surface which prevents touching / swabbing of the wound surface.
- •Subject has known allergy to silver dressings.
- •Subject is confirmed to be positive for HIV or hepatitis A, B or C.
- •Subject is pregnant and/or breastfeeding.
- •Subject is unable or unwilling to provide informed consent.
- •The wound is related to intravenous drug misuse.
- •A designated wound area may only be enrolled once in the study. For example, if an enrolled wound heals to complete closure and then re-opens, it cannot be re-enrolled in this study.
研究组 & 干预措施
Intervention
The wound will be treated with a silver antimicrobial dressing appropriate for the exudate level as per manufacturer instructions for use for 2 weeks +/- 3 days, in addition to any necessary standard care (e.g. compression for a venous leg wound).
干预措施: Silver antimicrobial dressing (Device)
Control
The wound will be treated as per usual care.
干预措施: Standard care (Device)
结局指标
主要结局
Mean wound area percent change
时间窗: 12 weeks
To determine whether the use of WOUNDCHEK™ Bacterial Status to guide further management in chronic wounds improves the mean wound area reduction compared to usual care.
次要结局
- Mean time to healing(12 weeks)
- Referral to secondary care and surgical intervention(12 weeks)
- Total cost of care(12 weeks)
- Wound infections and antibiotic use(12 weeks)
- Quality of life using EuroQol EQ-5D-5L(12 weeks)
- Proportion of wounds healed(12 weeks)
- Quality of life using EuroQol EQ VAS(12 weeks)