ISRCTN34166832已完成未知
A 100 patient, prospective, randomised, clinical evaluation comparing clinical and health economic outcomes between patients with chronic or sub-acute wounds treated with either PICO or standard care dressings and a qualitative study to explore the experiences of patients receiving PICO with particular emphasis on concordance
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Patients >18 years old
- •2. Males and females. If female, they must not be pregnant or lactating. If female and of reproductive age, a pregnancy test will be provided.
- •3. The patient or their legal representative (if the patient is incapable of giving legal consent), is able to understand the trial and is willing to consent to the trial
- •4. Patients with sub-acute or chronic wounds (diabetic foot ulcer, pressure ulcer, venous leg ulcer, or other chronic) suitable for treatment with a PICO dressing
- •5. Wound duration less than or equal to 52 weeks
- •6. Wound area range more than or equal to 5 cm2 at start of screening period
- •7. Wound maximum linear dimension less than or equal to 15cm
- •8. Able to use English for the interview
排除标准
- •1. Patients with known allergies to product components (silicone adhesives and polyurethane films (direct contact with wound), acrylic adhesives (direct contact with skin), polyethylene fabrics and super-absorbent powders (polyacrylates) (within the dressing)
- •2. Wounds which have an infection which is not being treated with systemic antibiotics
- •3. Wounds which are actively bleeding
- •4. Exposure of blood vessels, organs, bone or tendon at the base of the reference wound
- •5. Exclude undermining or tunnelling present or suspected in the wound
- •6. Use of negative pressure device on wound in the last 30 days
- •7. Malignant wounds / malignancy in the wound
- •8. Systemic infection not being treated with systemic antibiotics
- •9. Simultaneous treatment with other experimental wound care procedures or devices
- •10. Patients with a known history of poor compliance with medical treatment
- •11. Patients who have participated in this trial previously and who closed or were withdrawn
- •12. Patients who are unable to understand the aims and objectives of the trial
研究者
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