The Clinical Safety and Effectiveness of HealiAid Collagen Wound Dressing in the Treatment of Different Wounds
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 主要终点
- Wound Healing
研究概览
简要总结
The goal of this open-label, post-market clinical follow-up study is to demonstrate the safety and effectiveness of HealiAid Collagen Wound Dressing in patients classified into different types of wounds: venous ulcers, bedsores, diabetic foot wounds and burn wounds.
The main questions it aims to answer are:
- The wound healing which was defined as the percentage of area change.
- The duration of wound healing.
- The granulation tissue growth of the wound.
- The wound exudate.
- Safety Indicators of which incidences after treatment.
HealiAid will be applied to eligible subjects who will later be followed up for 12 weeks.
详细描述
An open-label study will be performed in single center to monitor about 6 patients in each types of wounds: venous ulcers, bedsores, diabetic foot wounds and burn wounds, totally 24 patients, after the treatment of using HealiAid Collagen Wound Dressing (MAXIGEN BIOTECH INC., Taiwan) directly on the wound sites.
Follow-up visits will be at 1, 2, 4, 8 and 12(if needed) weeks after the treatment.
The primary endpoint of this study was the area percentage of healed wound at the 8-week post-treatment interval, which is also considered as the healing condition of the wound.
The secondary endpoints of this study were included the duration of wound healing, granulation tissue growth, wound exudate, and the incidence of safety events.
T-test or Wilcoxon rank-sum test will be used to test for the differences between baseline and each visit. Statistical significance was established at p < 0.05.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Patients over 18 years of age with wounds.
- •The venous ulcer has been present for at least 30 days without healing, graded as stage 3, and the wound is at least 1 cm^2 (maximum length x maximum width).
- •Diabetic foot wound is classified as Wagner grade 2, and the wound is at least 1cm^2 (maximum length × maximum width).
- •Bedsore (NPUAP) is graded as level 2, and the wound is at least 1cm^2 (Maximum length × maximum width).
- •Burn wound is classified as grade 2, and the wound is at least 1cm^2 (maximum length × maximum width).
- •The limbs of patients with venous ulcers and diabetes are assessed using Doppler to measure blood circulation, confirming adequate blood flow in the affected tissues.
- •After a complete debridement operation, confirm that there is no necrotic or viable lesion tissue.
排除标准
- •There is an inflammatory response clinically.
- •A wound site with bone exposure.
- •Existing conditions or diseases may affect wound healing(e.g., cancer, vasculitis, connective tissue disorders, or any immune system disorders).
- •Alcohol abuse.
- •Within the past 30 days prior to enrollment, any use of medications that may affect wound healing, such as those associated with dialysis, steroids, immunosuppressants, radiation therapy, or chemotherapy.
- •There are multiple ulcer wounds present on the same limb affected by the lesion.
- •Pregnant or lactating women.
- •It is known that there has been a previous allergic reaction to any component of the dressing.
- •Allergic to collagen.
结局指标
主要结局
Wound Healing
时间窗: Baseline, 8 weeks after treatment
The wound healing was defined as the percentage of area change at baseline and 8 weeks after treatment. The wound area was calculated by multiplying the length (direction from head to leg) by the width (widest part of the wound site, perpendicular to the length). The percentage of area change was calculated by the formula: (baseline wound area minus 8-week wound area)/baseline wound area \*100%.
次要结局
- Wound Healing(Baseline, 1, 2, 4, 12(if needed) weeks after treatment)
- Granulation Tissue Growth(Baseline, 1, 2, 4, 8, 12(if needed) weeks after treatment)
- Duration of Wound Healing(Baseline, 1, 2, 4, 12(if needed) weeks after treatment)
- Wound Exudate(Baseline, 1, 2, 4, 8, 12(if needed) weeks after treatment)
- Incidence of Safety Events(week 0 to week 12)