跳至主要内容
临床试验/NCT04669626
NCT04669626已完成不适用

The Ability of Octenilin® to Reduce Odour of Malodorous Wound - a Single-center Randomized Double Blinded Controlled Pilot Study

School of Health Sciences Geneva2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2020年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
2
主要终点
Assessment of wound odour

研究概览

简要总结

Malodours are a common complication of chronic wounds. They are the result of the proliferation of aerobic and anaerobic micro-organisms on the wound surface, where they metabolize healthy tissue which leads to the production of sloughy and even necrotic tissue. Wound odour has a big impact on the quality of life of patients.

Currently the standard of care for the management of malodourous wounds are systemic antibiotics, absorbent wound dressings with or without activated carbon and, topical antimicrobials. The application of topical antimicrobials such as antiseptics against wound odour is part of the standard care. One suggested antiseptic in a recent published standard is Octenilin®. There is ample anecdotal evidence about the efficacy of Octenilin® in reducing wound odour. Therefore, we propose here to document this ability by evaluating the odour of wounds washed with Octenilin® versus standard care (NaCl 0.9% solution).

详细描述

Malodours are a common complication of chronic wounds. They are the result of the proliferation of aerobic and anaerobic micro-organisms on the wound surface, where they metabolize healthy tissue which leads to the production of sloughy and even necrotic tissue. Wound odour has a big impact on the quality of life of patients. Patients describe living with a chronic malodourous wound as devastating particularly in respect to social interaction. The key to addressing the negative consequences of malodorous and/or discharging wounds is an effective wound managements plan based on accurate and holistic assessment of the patient and the wound.

Currently the standard of care for the management of malodourous wounds are systemic antibiotics, absorbent wound dressings with or without activated carbon and, topical antimicrobials. The application of topical antimicrobials such as antiseptics against wound odour is part of the standard care. One suggested antiseptic in a recent published standard is Octenilin®. Octenilin® wound cleansing solution is on the Swiss market since 2006 and is routinely used in outpatient wound care centers. It exhibits good performance in the reduction of biofilm's pathogens and has excellent moisturizing properties. While there is ample anecdotal evidence about the efficacy of Octenilin® in reducing wound odour, we propose here to document this ability by evaluating the odour of wounds washed with Octenilin® versus standard care (NaCl 0.9% solution).

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

入选标准

  • A chronic malodourous wound
  • Age over 18 years
  • Proficiency in the French language

排除标准

  • Valid informed consent is not or cannot be given
  • Patients needing dressings with Silver
  • Patients needing charcoal dressings
  • Patients under antibiotic treatment

结局指标

主要结局

Assessment of wound odour

时间窗: 12 weeks

assessment of wound odour intensity by the study nurse using a Visual Analog Scale (VAS) from 0 to 100 (perceived odour).

次要结局

未报告次要终点

研究者

发起方
School of Health Sciences Geneva
申办方类型
Other
责任方
Sponsor

研究点 (2)

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