jRCT2052210072进行中（未招募）不适用
Confirmatory clinical trial of silk-elastin sponge (P47K-WAS) for patients with skin defects
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 25
- 主要终点
- Ratio of case judged to have been in condition that it was able to close wound
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 20age old over 至 No limit（—）
- 性别
- All
入选标准
- •[Case of chronic wounds]
- •The total wound size after 4 weeks of conventional treatment was still more than 50% of the wound size at the first visit.
- •The wound area (long times short diameter) after debridement ranged from 2cm^2 to 25cm^
- •When the wound was covered by the P47K-WAS, it could be sealed by woun dressing.
- •When the wound was present at the same time as the target wound, there was healthy skin between the wounds.
- •There was no local infection in the wound.
- •The proportion of the area that exposed bone was <10% of the total wound area.
- •In the case of chronic wounds on the lower legs, feet, and toes, the skin perfusion pressure of the affected leg exceeded 30mm Hg.
- •Those that can be diagnosed as diabetic ulcers, venous stasis uclers, decubitus, etc. as background diseases of the wound.
- •[Case of acute wounds]
- •The following wounds, which had no intrinsic factors that prolong wound healing and were considered to require wound bed preparation (WBP).
- •Complex wound, the burn that was higher than invasion depth grade II, the local infection wound that were considered to be controllable and soothing.
- •The wound area (long times short diameter) after debridement ranged from 2cm^2 to 100cm^
- •When the wound was covered by the P47K-WAS, it could be sealed by wound dressing.
- •When the wound was present at the same time as the target wound, there was healthy skin between the wounds.
- •There was no local infection in the wound.
- •The proportion of the area that exposed bone was <10% of the total wound area.
排除标准
- •The patient was < 20 years old when he/she consented to participate in the trial.
- •Womans that fell under any of the following.
- •. Women who did not consent to use contraception during the trial
- •. Women who were or could be pregnant
- •. Women who were nursing
- •Patients with previous histories of allergy against silk, urethane, and other reagents used in the trial, including anesthetics and disinfectant
- •Patients with any of the following conditions:
- •. Poorly controlled diabetes (>10% of HbA1c in the latest laboratory findings within 28 days before enrollment)
- •. Hypoalbuminemia (< 2 g/dL)
- •. Patient was being treated for malignancy.
- •. Patient required continuous systemic administration of steroids (dose exceeding an equivalent predonisolone dose of 10mg/day).
- •Patients participated in another clinical trial within 3 months before enrollment.
- •Wounds that were difficult to do decompression relief.
- •Patients participated in this trial and were administered the investigational device.
- •Patients who were not able to consent in writing to participate in the trial.
- •Patients who were considered by an investigator or sub-investigator to be inappropriate for inclusion in the trial.
结局指标
主要结局
Ratio of case judged to have been in condition that it was able to close wound
时间窗: 14th day after application of the P47K-WAS
Ratio of case judged to have been in condition that it was able to close wound
次要结局
未报告次要终点
研究者
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