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临床试验/NCT05685628
NCT05685628招募中不适用

Evaluation of the Quality of Life Induced by the Cinnamon Anti-odor Dressing in Patients With Malodorous Wounds: a Multicenter Randomized Controlled Trial

Assistance Publique - Hôpitaux de Paris13 个研究点 分布在 1 个国家目标入组 98 人开始时间: 2023年10月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
98
试验地点
13
主要终点
Wound-Qol

研究概览

简要总结

Refer to "Detailed description".

详细描述

Wounds can smell bad when they are necrotic, infected, malignant or complicated by fistulas or abscesses. The discomfort and evocations (perception) associated with these smells can be different from person to person. Foul odors are often associated with a repulsive effect. Malodorous wounds can have negative social and psychological repercussions (shame, depreciation, isolation).

Malodor is due to the presence of bacteria, whether the wound is colonized or infected. Bacteria release Volatile Organic Compounds (VOCs) that emit these odors. There are a multitude of anti-odor treatments (conventional or not) that highlight the difficulty of effectively treating this symptom.

Charcoal dressings are recommended. Charcoal does not treat the etiology, it is not odorous, but it has the ability to adsorb VOCs.

To treat odor, the most prescribed antibiotic is Metronidazole, because its action targets anaerobic bacteria whose presence increases odor. But repeated prescriptions of antibiotics increase the risk of selection pressure, in addition to possible side effects. It's not efficient in all the situations

Another strategy is the application of local antimicrobials. But it is effective only if the bacteria responsible for the odors are on the surface of the wound, which is not the case if it is a tumor mass, thick necrosis or abscesses.

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
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

入选标准

  • Patient >18 years of age with a smelly wound (discomfort > 4/10 expressed by the patient);
  • Predictive wound healing >14 days (clinical judgement);
  • Patient benefiting from a social security scheme (AME excluded)
  • Patient, and curator if applicable, informed and having signed the consent form for participation in the study

排除标准

  • Patient who has received a secondary charcoal or cinnamon dressing within the last 48 hours
  • Patient with pressure ulcer stage 1 or 2
  • Patient treated by metronidazole or antimicrobial for < 3 days;
  • Patient who cannot communicate his feelings;
  • Anosmic patient;
  • Patient with cinnamon allergy;
  • Persons deprived of their liberty or under guardianship;
  • Inability to submit to the medical follow-up of the trial for geographical, social, psychological or cognitive reasons.

研究组 & 干预措施

Cinnamon dressing group

Experimental

Use of the cinnamon dressing for 14 days

干预措施: Cinnamon dressing (Other)

Charcoal dressing Group

Active Comparator

Use of the charcoal dressing for 14 days

干预措施: Charcoal dressing (Other)

结局指标

主要结局

Wound-Qol

时间窗: Day 0 and 14

Wound-QoL (Questionnaire on quality of life with chronic wounds) measures the disease-specific, health-related quality of life of patients with chronic wounds. It can be used in clinical and observational studies as well as in daily practice. Two versions are available and we decided to use the original version (Wound-QoL-17) with 17 items. The primary endpoint is the reduction of more than 0.4 points in the overall score of the Wound-Qol quality of life questionnaire between D0 and D14.

次要结局

  • Odor discomfort / patient(Day 1)
  • Odor discomfort / nurse(Day 0, 7 and 14.)
  • SEFI® Scale to assess appetite(Day 0, 7 and 14.)
  • Dressing qualities(Day 3)
  • Odor discomfort / family(Day 0, 7 and 14.)
  • Cutaneous reaction or dressing discomfort(Day 14)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (13)

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