A Pilot Study of the WoundWand™ Debridement Device on Infection Prevention
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Bacterial Diversity and Number of Bacteria Present in the Wound
研究概览
简要总结
A Pilot Study of the WoundWand™ Debridement Device on Infection Prevention
详细描述
The primary aim of this pilot study is to investigate differences in bacterial content of the study wound that may impact upon infection rates following debridement with the WoundWand Debridement Device or Standard of Care (SoC) surgical (sharp) debridement. Additionally, the clinical investigation will evaluate reduction in wound size post-debridement and gather Health Economic data relating to wound bed debridement with the WoundWand Debridement Device or SoC.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who meet the following criteria may be included in the clinical investigation, if they present with ALL of the following:
- •Subject is able to understand the evaluation and willing to consent and comply with all post-debridement visits and procedures
- •Age 18 years and older. Subjects may be of either sex and of any race or skin type
- •Subjects fulfilling any one or all of the following criteria:
- •chronic wound(s) below the level of the knee, defined by delayed healing or cellular senescence
- •acute wound(s) as a result of a surgical procedure, laceration, abrasion or trauma
- •diabetic foot ulcer(s)
- •subjects with venous leg ulcers below the knee on the leg or foot with one or more documented failure of maximal medical therapy for their study wound >30 days such as compression bandages (low elasticity, elastic, multilayered, elastic and non elastic compression)
- •Subjects with the following lab results within 30 days of treatment:
- •serum albumin level >20g/L
- •clinically non significant results of liver function test (LFTs), serum glucose and complete blood count (CBC) with differential
- •Subjects with a Braden Score ≥13-14 (Moderate Risk)
- •Subjects with adequate arterial blood flow [Ankle-Brachial Index (ABI) >0.75]
排除标准
- •Subjects will be excluded from the clinical investigation, if they present with ANY of the following:
- •Subjects that have tunneling wounds
- •Subject presents with an active infection in the study wound, as defined by purulence and:
- •Fever and leukocytosis
- •OR any TWO of the following:
- •Malodor, pain or tenderness, warmth, erythema, induration, swelling, lymphangitis
- •Infected bone diagnosed by imaging modality (e.g., Magnetic Resonance Imaging (MRI) and/or radiographic images)
- •Subjects whose study wound does not require debridement
- •Cardiac pacemaker or other electronic implant(s)
- •Subjects with irradiate, burn or ischaemic wounds or history of keloids
- •Subjects with vasculitis, non-reconstructive peripheral vascular disease, pyoderma gangrenosum, renal failure or lymphoedema
- •Subjects with uncontrolled bleeding disorder (PT/PTT) and coagulopathy (including those with hemophilia)
- •Subjects taking treatment with any of the following:
- •Systemic corticosteroids
- •Immunosuppressive agent(s)
- •Chemotherapy or Radiation therapy
- •Subjects deemed to require biologic dressing/ skin substitute
- •Terminally ill subjects
- •Subjects that have an immunodeficiency disorder that interferes with wound healing, including Acquired Immunodeficiency Syndrome (AIDS) or know to be infected with Human Immunodeficiency Virus (HIV)
- •Subjects that have chronic skin conditions such as psoriasis, etc.
- •Subjects that reside in a nursing home
- •Subject is physically or mentally compromised (e.g., currently being treated for a psychiatric disorder, senile dementia, Alzheimer's disease, etc.) to the extent that the Investigator judges the subject to be unable or unlikely to remain compliant
- •Subject is pregnant and/or intending to become pregnant during this clinical investigation period
- •Subject has documented evidence of a history (e.g. liver testing) of drug/alcohol abuse within the 12 months prior to enrollment for clinical investigation entry
- •Subject is excluded if they have received an investigational therapy or approved therapy for investigational use within 30 days of surgery
- •Subject is excluded if planning to participate in another research study during the follow-up phase of this study or 84 days after study completion
研究组 & 干预措施
WoundWand™ Debridement Device
Group I - Coblator IQTM Controller plus WoundWandTM Debridement Device. Electrical energy that removes necrotic, ischemic, and/or infected tissue within a wound.
干预措施: WoundWand™ Debridement Device (Device)
Standard of Care sharp debridement
Group II - Standard of Care (SoC) surgical (sharp) debridement. Sharp instruments that remove necrotic, ischemic, and/or infected tissue within a wound.
干预措施: Standard of Care sharp debridement (Device)
结局指标
主要结局
Bacterial Diversity and Number of Bacteria Present in the Wound
时间窗: Day 1 (immediately pre- and post-debridement) and 4 weeks post-debridement
Primary endpoint was to determine bacterial diversity and number of bacteria present in the study wound at 4 weeks post- debridement using either WoundWand Debridement Device or Standard of Care. Punch biopsies were performed per standard practice to quantify the type and amount of bacteria present in wounds debrided with either Standard of Care Sharp Debridement or WoundWand Debridement Device. Debridement of contaminated tissue is essential to prevent wound infection, promote healing, and provide a neat wound edge for the prevention of scaring. A 3-4 mm punch biopsy for quantitative tissue culture (i.e. bacterial content) will be collected from the study wound site immediately pre- and post-debridement and at Week 4. The punch biopsy will be performed per standard practice and if required, utilizing the appropriate analgesia \[e.g. general, local (e.g. 1% lidocaine with epinephrine)\]. Quantitative tissue culture will be completed according to the laboratory's standard procedures
次要结局
- Photograph Area Measurements to Determine Reduction in Wound Size(Visit 2 through Visit 8 (12 weeks))
- Wound Status Using Bates-Jensen Wound Assessment - Total Score(Screening through Visit 8 (12 weeks))
- Braden Scale for Predicting Pressure Sore Risk - Total Score(Screening through Visit 8 (12 weeks))