NCT02373956终止不适用
Evaluation of the Efficacy and Tolerance of Honey-impregnated Dressings Versus Non-impregnated Dressings in the Local Management of Pressure Ulcers: A Randomized Single-blind Trial
Centre Hospitalier Universitaire de Nīmes6 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2015年11月20日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 24
- 试验地点
- 6
- 主要终点
- Change in wound surface area according to the Gilman formula
研究概览
简要总结
The main objective of this study is to document the effectiveness of a honey-based medical device (Hyalumel) in the management of pressure ulcers. The effectiveness of the medical device will be judged according to the evolution of the surface of the wound at the end of 12 weeks of treatment.
详细描述
The secondary objectives of this study are to compare the following items between the two arms of the study:
A. The evolution of skin microbiota in the wound B. The evolution of the surface and the depth of the wound during follow-up C. The healing process D. Patient and caretaker acceptability
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
- Single (Outcomes Assessor)
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
- •Information provided on the implementation of the study, its objectives, constraints and patient rights
- •The patient, or his/her legal guardian, must have given his/her informed and signed consent
- •The patient must be insured or beneficiary of a health insurance plan
- •The patient is available for 12 weeks of follow-up
- •Presence of one or more pressure ulcers at stages 2, 3 or 4 according to the European Pressure Ulcer Advisory Panel - National Pressure Ulcer Advisory Panel (EPUAP-NPUAP) classification
- •Wound whose surface is between 1 cm^2 and 15 cm^2
- •Wound present for more than 6 weeks
- •Patient whose wound requires a modern dressing (that is to say, a bandage that is neither tulle nor gauze) without bactericidal agents or antibiotics
- •No antibiotics for at least 7 days prior to inclusion (after inclusion, the patient can be treated with antibiotics if necessary, regardless of the indications)
排除标准
- •Patient participating in or having participated in another interventional study in the previous 3 months or currently in a patient exclusion period determined by a previous study.
- •Patient under judicial protection
- •Failure to correctly inform the patient or his/her legal representative
- •Patient (or his/her legal guardian) refusal to sign the consent
- •The patient is pregnant, parturient, or breastfeeding
- •Contraindications (or incompatible combination therapy) for a necessary treatment in this study
- •Patient with an allergy to honey or propolis
- •The patient's general condition suggests study exclusion before twelve weeks of follow-up
- •Antibiotics received within 7 days prior to inclusion
- •Active neoplastic lesion treated with radiation or chemotherapy
- •Immunosuppressive therapy or other treatment which, in the judgment of the investigator, may interfere with the healing process
- •Surgery planned within twelve weeks of inclusion
- •Stage 1 wound according to the EPUAP-NPUAP classification
- •Amputation wound
- •Wound related to a surgical treatment or for which an act of revascularization is envisaged within twelve weeks of inclusion
- •Malignant wound
结局指标
主要结局
Change in wound surface area according to the Gilman formula
时间窗: Week 12
According to the Gilman formula
次要结局
- Is the wound completely healed? yes/no(Week 12)
- Presence/absence of adverse events(At treatment stopping if appropriate (before week 12))
- Wound healing speed (change in cm^2 of surface area per week)(12 weeks (or maximum time span if total healing occurs before 12 weeks))
- Has the wound surface area reduced by at least 40%? yes/no(At treatment stopping if appropriate (before week 12))
- Number of bacteria species present in the wound(Day 84)
- Number of bacteria functional groups present in the wound(Day 84)
- The number of multiresistant bacteria species present in the wound(Day 84)
- The time to healing (days)(Week 12)
- Change in wound surface area according to the Gilman formula(At treatment stopping if appropriate (before week 12))
- Relative variation (%) in wound surface area(At treatment stopping if appropriate (before week 12))
- Relative variation (%) in wound depth(At treatment stopping if appropriate (before week 12))
- Diversity (Shannon's H) of bacteria species present in the wound(Day 84)
- Diversity (Shannon's H) of bacteria functional groups present in the wound(Day 84)
- the ratio of the number of commensal over the total number of bacteria species present in the wound(Day 84)
- the ratio of the number of commensal or weakly virulent over the total number of bacteria species present in the wound(Day 84)
- Appearance of the pressure ulcer(At treatment stopping if appropriate (before week 12))
- Algo plus scale(At treatment stopping if appropriate (before week 12))
- Acceptability of the dressing by the medical staff(At treatment stopping if appropriate (before week 12))
研究者
研究点 (6)
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