An Open, Non Controled, Single-centre, Clinical Investigation to Evaluate Efficacy in Second Degree (Superficial, Deep or Mixed) Partial Thickness Burns When Using a Soft Silicone Wound Contact Ayer Containing Silver.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 4
- 主要终点
- Number of Participants With Wound Healing
研究概览
简要总结
Approximately 10 subjects from one clinic having sustained a burn injury covering 1-25% or the Total Body surface Area (TBSA)and assessed as superficial partial-thickness or superficial deep-partial-thickness. The subject will be assessed once a week for a maximum of 3 weeks or until the burn is healed if that occurs earlier. . The dressing Mepilex Transfer Ag will be used as wound contact layer and gauze rolls and compression as second dressing.
详细描述
Approximately 10 subjects from one site will be evaluated provided they fulfill the inclusion criteria and none of the exclusion criteria and gives a signed and dated consent.
Subjects may have sustained a burn injury covering 1-25% of the Total Body Surface Area (TBSA)and assessed as superficial partial-thickness or superficial deep-partial thickness in dept. Each subject will be followed one time per week for a maximum of 3 weeks or until the burn is healed if that occurs earlier. Healing is defined as ≥95% epithelialisation. Percent (%) healed epithelialization will be measured by photo analysing using the PictZar program. Dressing changes will be performed at each visit and in between if deemed necessary by the investigator.Gauze rolls and compression will be used as secondary dressing.All dressing changes will be registered in a log. Pain before, during and after removal will be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Subject with a second degree (superficial, deep or mixed) partial thickness burn from 1-25% TBSA.
- •One single, isolated burn area selected for study site Study site area should be between 1-15% BSA
- •Male or female
- •From 18 years and above
- •Either in- or out-patient
- •Thermal burn injury
- •Signed Informed Consent/Assent Form
排除标准
- •Electrical, chemical burn etiology
- •If any full thickness areas are present, these should not be > 5 %
- •Burn greater than 36 hrs old
- •Burns to face
- •Use of chemical/enzymatic and biological debridement within 7 days of investigation start
- •Presence of inflammation or infection in burn wounds
- •Use of topical antibiotics, antiseptics, or antimicrobials in conjunction with study product.
- •Subjects with lung injury or Subject being on a ventilator
- •Subjects with dermatologic skin disorders or necrotizing processes
- •Subjects with insulin dependent diabetes mellitus judged by the investigator to be a potential interference in the treatment
- •Diagnosed underlying disease(s) (e.g HIV/AIDS, cancer and severe anaemia) judged by the investigator to be a potential interference in the treatment
- •Subject not expected to follow the investigation procedures
- •Subjects previously included in this investigation
- •Subjects included in other ongoing clinical investigation at present or during the past 30 days
结局指标
主要结局
Number of Participants With Wound Healing
时间窗: 14 days and 21 days
Healing at day 14 pt 21. Healing was defined as ≥95% epithelialisation. The PictZar program will be used to analyze burn wound healing by tissue type. ("The PictZar equipment for this analysis will be located at MHC HQ, however, the analysis will be performed by a clinician not affiliated with MHC.") Each subject was followed/assessed one time per week for a maximum of 3 weeks or until the burn was healed if that occured earlier.
次要结局
- Baseline (Visit 1) Pain Will be Measured Before Burn Assessment Visit 2-3, Pain Will be Measured (Pain BEFORE Dressing Removal, DURING Dressing Removal, AFTER Dressing Removal, 30 Min After Removal(After 0/14/21 days treatment)