Randomized, Active-controlled, Single-blind, Parallel Two-group Trial of HQ® Matrix Medical Wound Dressing and Sidaiyi® Wound Dressing for the Treatment of Donor Site Wounds
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 2
- 主要终点
- Time to Wound Healing
研究概览
简要总结
The purpose of the study is to evaluate the safety and effectiveness of HQ® Matrix Medical Wound Dressing for repair of donor site wounds. Half of participants will receive HQ® Matrix Medical Wound Dressing, while the other half will receive Sidaiyi® wound dressing.
详细描述
HQ® Matrix Medical Wound Dressing is a transparent, non-porous, pliable, gas-permeable, and waterproof film dressing which is comprised of silk fibroin protein of the Bombyx mori (B. mori) silkworm. It is intended to provide a moist, gas-permeable and sterile environment to facilitate the normal wound healing process. It is used in the management of non-infected skin defects and various dermal wounds.
Sidaiyi® wound dressing (Suzhou Soho Biomaterial Science and Technology Co., Ltd, Suzhou, China) is a CFDA approved (Su2012-2640182), silk fibroin-based, two-layered spongy dressing. Upon the silk fibroin spongy dressing layer is a membrane made of medical silicone. It is used in the management of partial- and full-thickness wounds, donor site wounds and burns. Currently, it is the sole silk fibroin biomaterial for wound healing that has received regulatory approval worldwide.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients, aged from 18 - 60, male or female, with wet wounds or burns, ulcerative skin and soft tissue wound surfaces;
- •The wound surface area ranged from 20cm^2 to 600cm^2;
- •The patients had a clear mind and there was no misunderstanding;
- •The patients voluntarily signed the subjects' informed consent form and received timely follow-ups.
排除标准
- •Patients with active bleeding in wound surfaces;
- •Vasogenic diseases: patients with no blood supply or phlebothrombosis in local wound tissues;
- •Those allergic to silk materials;
- •Those with serious infection;
- •Those with coagulation disorders;
- •Those with tumors or diabetes;
- •Patients who, according to other doctors' opinion, are unsuitable to use this material for wound treatment.
结局指标
主要结局
Time to Wound Healing
时间窗: Days 0, 3±1, 7±1, 10±2, 14±3, and 21±3 post-operation
Healing time was recorded when complete re-epithelialization had occurred. If the wound healed in advance, visit until the wound was completely healed. If the wounds were unable to heal for more than 21±3 days, unanticipated follow-ups were added until the wound was completely healed.
次要结局
- Number of Participants With Growth of Granulation Tissue(Days 0, 3±1, 7±1, 10±2, 14±3, and 21±3 post-operation)
- Number of Participants With Inflammatory Reaction(Days 0, 3±1, 7±1, 10±2, 14±3, and 21±3 post-operation)
- Pain Perceived by Patient(Days 0, 3±1, 7±1, 10±2, 14±3, and 21±3 post-operation)
- Number of Participants With Exudation(Days 0, 3±1, 7±1, 10±2, 14±3, and 21±3 post-operation)