Clinical and Mechanistic Demonstration of a Bioelectric Dressing System for Non-healing Wound Management: A Phase II Randomized Trial
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Clinical Efficacy
研究概览
简要总结
Utilizing wound healing trajectory analysis, patient-reported pain and QOL assessment, quantitative bacteriology, and inflammatory infiltrate quantification, an improvement in wound healing will be observed on a cellular, histomorphological and clinical level in the presence of a bioelectric dressing applied in conjunction with SOC.
详细描述
The PROCELLERA Antimicrobial Wound Dressing is considered a non-interactive wound dressing containing silver and zinc, classification product code MGP. Non-interactive wound dressings are considered by FDA to be non-significant risk, as per their Investigational Device Exemptions Manual (publication FDA 96-4159).
Procellera is FDA cleared under K081977 for professional use as a wound dressing for partial and full-thickness wounds.
Selection of Subjects
Type of the Subject Population
- At least 18 years old
- Male or female
- All ethnic groups
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •> 18 years of age or older, male or female
- •Female subject not pregnant - pregnancy excluded by HCG (urine or serum) or by history (tubal ligation, hysterectomy, or menopause).
- •Have a non-healing external wound at any location of the body of ≥90 days duration that is (10-50 cm2) at initial screening and does not exceed 3 cm in depth.
- •May have a wound requiring Negative Pressure Wound Therapy in conjunction with standard of care wound treatment.
- •Subject is able to apply study dressing to his/her wound, or have a reliable and capable caregiver to do it.
- •Subjects will have adequate blood flow to the wound as defined by Skin Perfusion Pressure (SPP)47-49 of >30mmHg recorded over intact epidermis near the open wound margin.
- •Subjects with arterial repairs having adequate blood flow to the wound as defined by Skin Perfusion Pressure (SPP) of >30mmHg recorded over intact epidermis near the open wound margin.
- •Absence of clinical signs of infection (such as fever; malodorous wound exudate; increasing wound pain, drainage, erythema, friable granulation tissue and or edema).
- •Participant agrees to participate in follow-up evaluations.
- •Participant must be able to read and understand informed consent, and signs the informed consent.
排除标准
- •Less than 18 years of age.
- •Pregnant or lactating woman.
- •Have undergone treatment with systemic corticosteroid or immunosuppressive therapy in the past 2 months.
- •Currently undergoing dialysis for renal failure.
- •Subject has wounds resulting from electrical burn, arterial insufficiency, chemical or radiation insult.
- •Subject has wounds with exposed bone, ligament, nerve, artery and/or tendon.
- •Active or previous (within 60 days prior to the study screening visit) chemotherapy.
- •Active or previous (within 60 days prior to the study screening visit) radiation to the affected wound area to be treated by study device or standard of care.
- •Physical or mental disability or geographical concerns (residence not within reasonable travel distance) that would hamper compliance with required study visits.
- •The Investigator believes that the subject will be unwilling or unable to comply with study protocol requirements, including application of bioelectric dressings, standard-of-care self-care requirements, and all study-related follow up visit requirements.
- •History of infection with Human Immunodeficiency Virus or other immunodeficiency disorders.
- •Heterotopic ossification underlying the wound based upon previous imaging or historical information from the subject's chart.
- •Severe anemia - Hgb < 7 g/dl (males) or < 6.5 (females) or coagulopathy (INR > 1.7).
- •Severe malnutrition (Albumin < 3.0 gm/dl; > 10% weight loss in preceding 6 weeks).
- •Allergy to silver or zinc.
研究组 & 干预措施
Bioelectric Dressing
SOC + Bioelectric Dressing
干预措施: Procellera (Drug)
结局指标
主要结局
Clinical Efficacy
时间窗: 2 years
Assessment of the clinical efficacy of a bioelectric dressing in conjunction with standard-of-care on the healing rate of chronic soft tissue wounds compared with standard-of-care alone. In this 50-subject study, the primary endpoint for efficacy will be the rate of healing (healing trajectory) in the treatment group compared to that of the control group, during the 12-week treatment study period. It is hypothesized that a bioelectric dressing will reduce wound healing time when compared to SOC treatment, thereby accelerating wound healing trajectory.
次要结局
- Dressing Efficacy(2 Years)