Medical Honey for Wound Treatment in Intensive Care. (MICARéa) Randomized, Controlled, Single-center Pilot Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- percentage of wound area reduction measured 15 days after inclusion (or on hospital discharge if before Day15).
研究概览
简要总结
Wound management is a real public health issue in France. To date, a wide range of devices exists to treat these wounds, depending on their nature and stage of evolution. Honey has been proposed for the care of wounds and is effective in reducing the surface of wounds and the pain perceived by patients. Inanition, its use is very simple compared to usual care, requiring different types of dressing accross time. In the intensive care unit, patients are prone to suffering or developing numerous types of wound, but the interest of honey has not been investigated yet.
We propose a prospective, monocentric, randomized, single-blind, controlled clinical trial to assess the efficacy of managing acute cutaneous wounds with honey (Activon®) compared with standard care, in intensive care patients. The primary endpoint is the percentage of wound surface area reduction measured at 15 days from inclusion.
详细描述
Wound management is a real public health issue in France. It affects around 2 million people, and represents a cost of almost 1 billion euros for chronic wounds. Patients in the intensive care unit are prone to suffering or developing numerous types of wound: ulcers, surgical or traumatic wounds on admission or during the stay, pressure sores and wounds associated with medical devices...
Several studies have evaluated the use of honey in chronic and acute wounds. It is effective in reducing wound surface area and decreasing pain perceived by patients. A few randomized controlled studies also show faster wound healing, with a significantly greater reduction in surface area, but these mainly concern chronic wounds with long treatment times. Although medical honey is CE-marked for the treatment of acute wounds, no studies have been carried out on the intensive care patient population. The aim of this study is to assess the efficacy of honey (Activon® , Advancis Medical laboratory - DEODAMED, Saint Die des Vosges - France) in the treatment of wounds occurring in intensive care patients, compared with the use of standard devices.
Critically ill patients with one or more acute wound (ie <8 days), will be included in absence of known allergy to honey and after consent (by the patient of his/her next of kin if he/she is not able to consent). The wound will be randomized to be treated with honey or standerd care, a maximum of 3 wounds will be randomized by patients. A drawing of the wound will be taken using a layer at inclusion, D7 and D15 (or hospital discharge if it happens first). The area of the wound will be measures by 3 nurses, blinded to the treatment arm, using the formula (A=LengthxWidthxπ/4). The patients will be follow-up at 3 months with a on-site visit to record the date of definitive wound healing.
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)
盲法说明
The primary outcome is the area of the wound, which will be measured by 3 nurses blinded to the study arm, using a layer of the wound.
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
- •Hospitalization in surgical intensive care unit A -USC PTO CHU ANGERS
- •Informed consent signed by patient or relative (or emergency inclusion procedure)
- •Patient with one or more wounds ≥ 4 cm2, evolving for less than 8 days, including: stage 2, 3, 4 pressure sores, lacerations, ulcers, dermabrasions and scar disunions.
排除标准
- •Patients with honey intolerance/allergy to bee stings
- •Patients with wounds lasting more than 8 days
- •Patient with a bleeding wound,
- •Patient with a tunneled wound
- •Patients with chronic dermatoses
- •Patient with an estimated life expectancy < 15 days
- •Expected discharge ≤48 hours.
- •No affiliation to a French social security scheme or beneficiary of such a scheme.
- •Pregnant, breast-feeding or parturient woman
- •Person deprived of liberty by judicial or administrative decision
- •Person subject to a legal protection measure
研究组 & 干预措施
medical honey
the patients randomised to this arm will have honey (Activon® Advancis Medical.)
干预措施: medical honey Activon® 25g Tube (Device)
standard of care
the patients randomised to this arm will have standard of care recommanded by HAS (french organisation)
干预措施: standard of care (Device)
结局指标
主要结局
percentage of wound area reduction measured 15 days after inclusion (or on hospital discharge if before Day15).
时间窗: 15 days
R = (AJ15-AJ0)/SJ0 x100 with wound area obtained as the mean of the measures made by 3 nurses using a layer of the wound and the formula Area = maximal Length x maximal Width x π/4 R, percentage reduction in surface area (expressed in %); S, surface area (cm²); D, day; D0=day of inclusion
次要结局
- total honey tubes(Day90)
- scarring progress(Day0, Day7, Day15 and Day90:)
- total healing,(Day0, Day7 and Day15)
- Dressing time(Day0, Day7 and Day15)
- numbers of honey tubes used for dressings(Day0, Day7 and Day15)
- percentage of patient with pain(Day0, Day7 and Day15)