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临床试验/NCT04831112
NCT04831112已完成不适用

A Comparative Study Between the Use of Topical Honey and EUSOL Dressing in Necrotizing Fascitis Wounds

Dow University of Health Sciences1 个研究点 分布在 1 个国家目标入组 326 人开始时间: 2020年3月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
326
试验地点
1
主要终点
Early wound healing

研究概览

简要总结

Honey is super saturated solution containing sugar derived from nectar gathered by honeybee. Honey is viscus supersaturated solution mainly composed of sugar and water along with minor constituents such as minerals, vitamins, amino acids, organic acids, flavonoids, and other phenolic compound and aromatic substances. Honey contents according to percentages are fructose 38.6%, glucose 31%, water 17%, lactose 7.2%, larger sugars 4.7% and rest of micronutrients and elemental compounds are 1.5%. Honey enhances wound healing by removing slough and necrotic tissue from wound. It promotes wound healing by increasing angiogenesis, granulation and epithelization. Honey possess antimicrobial activity against bacteria like methicillin resistant staphylococcus aureus, vancomycin resistant Escherichia Coli, pseudomonas aeruginosa, and many other species. It also has activity against some yeast species such as aspergillus and penicillium.

Honey used for dressing will be 'Langnese Honey". Langnese honey is raw honey / unprocessed packed as collected, quality and quantity will be same for patients.

详细描述

This prospective randomized trial will be conducted in all patients undergoing dressing after debridement of necrotizing fasciitis wounds. Study will be conducted for 6 months after approval IRB. Patient will be inducted through emergency department. After debridement, patient will be enrolled in study via simple random sampling for dressing with either EUSOL or Honey. Honey quantity for wound will be 4ml per square inch. In patient whose both limbs involved by necrotizing fasciitis, after debridement, dressing will be done with honey in one limb and EUSOL in other limb. Patient will be enrolled in study whose debridement already done.

EUSOL is solution commonly used for dressing of wounds. Honey is also used for dressing of wounds. Honey is a viscous, supersaturated sugar derived from nectar gathered by a honeybee. Honey enhances wound healing by providing moist environment, antibacterial activity, deodorizes, decrease inflammation, edema and exudation. Honey increase rate of wound healing by promoting angiogenesis, granulation and epithelization. Dressing will be done by residents of our ward under supervision of faculty. At first time of debridement pus or tissue will be sent for culture and sensitivity meanwhile broad-spectrum antibiotic will be started. Once dressing will started, wide wound span will be measured and assessed daily for granulation tissue and removal of slough. Questionnaire will be filled by PI for allergic reaction to solution, appearance of granulation tissue and hospital stay.

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
Double (Participant, Care Provider)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age >18 years and <70 years.
  • Necrotizing fasciitis wounds
  • Wide span of wound <20cm

排除标准

  • Diabetic Foot wounds
  • Traumatic wounds

研究组 & 干预措施

Honey

Experimental

Topical honey to be used for dressing 4ml per square inch.

干预措施: Honey (Drug)

Honey

Experimental

Topical honey to be used for dressing 4ml per square inch.

干预措施: EUSOL (Combination Product)

EUSOL

Active Comparator

EUSOL soaked gauze to be placed over the wound as dressing.

干预措施: Honey (Drug)

EUSOL

Active Comparator

EUSOL soaked gauze to be placed over the wound as dressing.

干预措施: EUSOL (Combination Product)

结局指标

主要结局

Early wound healing

时间窗: 3 weeks

Early wound healing is measured via appearance of granulation tissue over the wound.

次要结局

  • Decreased hospital stay(4 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lajpat Rai

Principal Investigator

Dow University of Health Sciences

研究点 (1)

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