Feasibility Study to Compare OASIS Extracellular Matrix to Standard Wound Care for Treatment of Donor Site Wounds
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Donor site wound healing
研究概览
简要总结
The purpose of this study is to demonstrate the safety and performance of Oasis extracellular matrix (ECM) when used as a treatment for donor site wounds in the United Kingdom. Oasis ECM is commercially available for the treatment of partial and full-thickness skin wounds, including chronic wounds, wounds from trauma, and wounds that occur during surgery, such as donor site wounds. The ability of the Oasis ECM to promote the healing of donor site wounds will be evaluated in this study.
About 40 patients (20 in each arm) over 16 years old will be involved in this study at one center in the United Kingdom.
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 (Outcomes Assessor)
盲法说明
Randomization to treatment groups will be performed using a computer system to randomly assign subjects to treatment arms. Sealed envelopes numbered 1-40 will be provided to the study site. Patients will be assigned an envelope number upon providing informed consent. The envelope will be opened during the treatment procedure to minimize the risk of bias in patient assignment to the treatment group.
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has a split thickness skin graft (STSG) donor site wound no greater than 14 x 20 cm in size requiring placement of a covering material.
- •Has at least 24 hours to consent to study participation.
排除标准
- •Age < 16 years
- •Patients who, in the opinion of the investigator, have co-morbidities that impair wound healing, such as:
- •Chronic inflammatory skin condition
- •Chronic liver failure
- •Chronic renal failure
- •Blood-borne viruses (Hep B, Hep C, HIV)
- •Peripheral vascular disease
- •Clinically significant anaemia
- •Uncontrolled diabetes
- •Need for use of the same harvest site (re-cropping)
- •History of radiation therapy to proposed donor site
- •Chronic use of medications known to impair wound healing
- •Chronic use of opioids or neuropathic pain agents
- •Suspected cellulitis, osteomyelitis or septicaemia
- •Patients undergoing haemodialysis
- •Patients requiring spinal/regional block
- •Patients on current anti-coagulant therapy
- •Unable or unwilling to provide informed consent
- •Unable or unwilling to comply with the study follow-up schedule, and procedures
- •Simultaneously participating in another investigational drug or device study (patient must have completed the follow-up phase for the primary endpoint of any previous study at least 30 days prior to enrolment in this study)
- •Allergy or hypersensitivity to materials that are porcine-based
- •Cultural or religious objection to the use of pig or porcine products
- •Known intolerance/allergy to standard wound care products
- •Presence of a local infection at the donor site and/or systemic infection
结局指标
主要结局
Donor site wound healing
时间窗: 14 days
To demonstrate the percentage of patients with wounds healed at day 14
次要结局
- Adverse Events(up to 6 months)
- Amount of pain, analgesic usage(14 days)
- Amount of pain, patient perceived(14 days)
- Cosmetic Outcome utilizing POSAS(up to 6 months)