TCTR20180828003尚未招募2 期
A randomized, comparative study to assess the efficacy and safety of antimicrobial gauze pad coated with mangosteen extract versus 2% mupirocin ointment in the treatment of uncomplicated superficial bacterial skin infections in children.
Ratchadapiseksompotch Fund, Faculty of Medicine, Chulalongkorn University0 个研究点目标入组 60 人开始时间: 2018年8月28日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 12 Months 至 18 Years（—）
- 性别
- All
入选标准
- •1.Patients 12 months †18 years of age
- •2.Signs or symptoms of uncomplicated superficial bacterial skin infection, including both primary skin infection (impetigo, folliculitis, or minor soft tissue infection), and secondary skin infection (secondarily infected eczema, secondarily infected lacerations or sutured wounds or abrasions).
- •3.The superficial skin infection must be suitable for treatment with a topical antibacterial, not requiring surgical intervention
- •-Impetigo (bullous or nonbullous), folliculitis ≤ 10 lesions or ≤ 2% total body surface area.
- •-Secondarily infected lacerations or sutured wounds ≤ 10 cm long with surrounding erythema ≤ 2 cm from the edge of the lesion, or abrasions ≤ 2% total body surface area, with surrounding erythema ≤ 2 cm from the edge of the wound
- •4.Skin infection rating scale (SIRS) score at least 4 with at least 3/5 signs/symptom categories present.
排除标准
- •1.Patients who have demonstrated a previous hypersensitivity reaction to mangosteen, mangosteen extract, or any component of mupirocin ointment
- •2.Patients who have demonstrated a previous hypersensitivity reaction to plasters or other dressing materials
- •3.Secondarily infected animal/human bites or puncture wounds; abscesses; probable polymicrobial chronic ulcerative lesions unlikely to have been caused by S. aureus
- •4.Systemic signs and symptoms of infection requiring systemic therapy (e.g. fever, with oral temperature ≥ 38.3°C, widespread lesions > 2% total body surface area) or surgical intervention; a bacterial skin infection that, in the investigator’s opinion, could not be treated appropriately by a topical antibiotic (e.g. cellulitis, furunculosis, or abscess)
- •5.Underlying diseases that affect immunocompetency
- •6.Underlying life-threatening diseases
- •7.The use of topical therapeutic agents on the infected lesion, and systemic antibacterial or steroids, was prohibited within 48 hours prior to study entry and during the study
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