The Wound Healing Efficacy and Safety of Medifoam H in Patients With Minor, Acute Trauma: a Single-center, Randomized, Active-controlled, Open-label, Phase IV
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Wound healing rate according to amount of exudation at 1 week from baseline. If exudation is not existed, this will be defined as recovery
研究概览
简要总结
The wound healing efficacy and safety of "Medifoam H" in patients with minor, acute trauma.
The hypothesis of this study is that using "Medifoam H" dressing for a week is not inferior to using "Duoderm THIN" dressing in wound healing.
详细描述
This study is single-center, randomized, active-controlled, open-label, Phase IV to evaluate clinical efficacy of wound healing and safety of "Medifoam H" in patients with minor, acute trauma.
33 patients of treatment group and 33 patients of control group, total 66 patients will be enrolled to this study. Every patient will be treated with "Medifoam H" or "Duoderm THIN" for a week. During their participation, patients will visit 2 days and a week after to see investigator. Investigator will observe the wound and evaluate amount of exudation, infection status, 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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Who has acute trauma(Laceration, Abrasion, Stitched wound, under superficial second-degree burn etc.)who satisfies at least 1 condition between followings:
- •Laceration, Stitched Wound: Length of under 10cm.
- •Abrasion, Burn: Total area of under 100㎠ , Depth of under 2mm.
- •Agreed to participate voluntarily in the study
排除标准
- •Who has hypersensitivity to hydrocolloid or its history.
- •Deep or severe infectious diseases of skin(example: Phlegmon, Abscess, Ulcer, Boil etc..) which is hard to treat with this investigational product.
- •A wound which is bitten by animal, human or inject. Or a wound has possibility of secondary infection through the tresis.
- •Who need surgical intervention for infection treatment.
- •Who has bacterial, viral, animal infectious disease
- •Who judged inappropriate to participate in the study by investigator.
结局指标
主要结局
Wound healing rate according to amount of exudation at 1 week from baseline. If exudation is not existed, this will be defined as recovery
时间窗: 0 to 1 week
Wound healing rate according to amount of exudation at 1 week from baseline. If exudation is not existed, this will be defined as recovery. Exudation will be scored in 4 level: None/Mild/Normal/Severe.
次要结局
- Rate of infection on wound(1/3/7 days.)
- Amount of exudation at day 3.(3 days)
- Rate of wound healing(3/7 days)
- Rate of changes in tissue after treatment(3/7 days)
- Whether use of concomitant medication or not(1/3/7 days)
研究者
Jong-Won Rhie
Professor
Seoul St. Mary's Hospital