NCT02660541已完成不适用
A Pilot Study to Compare Efficacy of Allevyn® Silver Dressing and Betafoam® in Patients With Wound of Acute Burn Injury
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Comparison between Betafoam® and Allevyn® Silver dressing, measured by days needed for complete re-epithelialization in burn wounds
研究概览
简要总结
This is a randomized, controlled, multi-centre, open-label study.
A total of 40 patients will be enrolled in this study. Patients will be randomly assigned to Betafoam® or Allevyn® Silver dressing for burn wounds after acute burn injury.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults ≥ 19 years
- •Subjects of second-degree burn who have acute partial thickness burn (superficial to deep partial thickness) via investigator's visible assessment
- •Burn total body surface area of <15% range based on Lund and Browder chart presenting at the emergency room within the first 3~5 days post-injury will be considered for inclusion in this study.
- •(If more than one burn wound is present that meets the inclusion criteria, the largest one among wounds that size are between 10x10 ㎝ and 20x20㎝ will be preferred to select as the Target wound.)
- •Subjects who voluntarily sign the informed consent form
排除标准
- •Pregnant & lactating females
- •Known allergy to the dressing product including PVP-I
- •Known hyperthyroidism or other acute thyroid diseases
- •Subject with clinical infection who should be administered antibiotics continuously after enrolment
- •Subject has any condition(s) that seriously compromises the patient's ability to complete this study.
- •Subject has participated in interventional study utilizing an investigational drug within the previous 30 days
- •Subject has one or more medical condition(s), diabetes, including renal, hepatic, hematologic, neurologic, or immune disease that presumably to hinder the wound healing processes by the physician's judgement.
- •Subjects who are immune suppressed states, under chemo- or radiotherapy.
- •The surgeon decides that surgery is necessary or requiring skin grafting.
- •Burn injury sites at the ends of extremities and genitalia
- •Burn injury caused of electronic burn
- •Subjects who have inhaled damage, severe head injury or fracture on burn wound
- •Scintillation scan for the diagnosis of thyroid takes at intervals of 1 to 2 weeks when using this dressing
- •Vulnerable subjects.
研究组 & 干预措施
Betafoam
Active Comparator
Brand name: Betafoam® This is a medicated device (dressing) consisting of 3% povidone iodine.
干预措施: Betafoam (Device)
Allevyn Silver dressing
Active Comparator
Brand name: Allevyn® Silver
干预措施: Allevyn Silver Dressing (Device)
结局指标
主要结局
Comparison between Betafoam® and Allevyn® Silver dressing, measured by days needed for complete re-epithelialization in burn wounds
时间窗: 28 days
次要结局
- Safety assessed by documentation of adverse events, clinical laboratory results and vital signs(28 days)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
2 期
Efficacy and Safety of Acyclovir-penciclovir Cream Versus an Abreva in the Suppression of Herpes Simplex Virus EruptionsHerpes Simplex OralNCT06558838University of Utah40
已完成
1 期
Ranibizumab for Treating Submacular Vascularized Pigment Epithelial DetachmentsRetinal Pigment Epithelial DetachmentNCT00749021Clement K. Chan40
已完成
3 期
Ribavirin Loading Dose or Priming and Concentration Targeting for HCV Genotype 1Hepatitis CNCT01226771Göteborg University105
Unknown
不适用
A Trial to Compare Raltegravir Versus Nevirapine as Anchor Drug for HIV+ Chinese IDUs on Methadone MaintenanceHIVHIV InfectionsNCT01042652Centers for Disease Control and Prevention, China60
已完成
4 期
Comparison of Tacrolimus Extended-Release (Envarsus XR) to Tacrolimus Immediate-Release in Human Leukocyte Antigen (HLA) Sensitized Kidney Transplant RecipientsKidney Transplant RejectionNCT04225988Cedars-Sinai Medical Center20