A Pilot Study of the WoundWand™ Debridement Device on Infection Prevention

Study Overview
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Brief Summary
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A Pilot Study of the WoundWand™ Debridement Device on Infection Prevention

Detailed Description
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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.

Official Title
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A Pilot Study of the WoundWand™ Debridement Device on Infection Prevention

Conditions
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Lower Leg Wound

Intervention / Treatment
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* Device: WoundWand™ Debridement Device
* Device: Standard of Care sharp debridement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria 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] Exclusion Criteria 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: WoundWand™ Debridement Device<br>Group I - Coblator IQTM Controller plus WoundWandTM Debridement Device. Electrical energy that removes necrotic, ischemic, and/or infected tissue within a wound. | Device: WoundWand™ Debridement Device<br>* Group I - Electrical energy that removes necrotic, ischemic, and/or infected tissue within a wound<br>|
| Active Comparator: Standard of Care sharp debridement<br>Group II - Standard of Care (SoC) surgical (sharp) debridement. Sharp instruments that remove necrotic, ischemic, and/or infected tissue within a wound. | Device: Standard of Care sharp debridement<br>* Group II - Sharp instruments that remove necrotic, ischemic, and/or infected tissue within a wound<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bacterial Diversity and Number of Bacteria Present in the Wound | 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 | Day 1 (immediately pre- and post-debridement) and 4 weeks post-debridement | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Photograph Area Measurements to Determine Reduction in Wound Size | a) Reduction in wound size for up to 12 weeks post-debridement Photographs of the wound site were taken to determine the reduction in wound size and to assess healing progression of the study wound. Standardization of images was ensured by the Eykona® Wound Measurement System that uses small sterile 'targets' placed on the study wound to set the focus and position of the camera thus eliminating inconsistency between images acquisition time points. The photographs are stored on a USB (Universal Serial Bus) flash drive which will be archived with the study files. | Visit 2 through Visit 8 (12 weeks) | 
| Wound Status Using Bates-Jensen Wound Assessment - Total Score | The Bates-Jensen Wound Assessment Tool is a 13-item questionnaire (size, depth, edges, undermining, necrotic tissue type, exudate type, exudate amount, skin color surrounding wound, peripheral tissue edema, peripheral tissue induration, granulation tissue, epithelialization) used to assess wound status. Total score is determined by adding together the sub-scores from each of the 13 items, with a higher score indicating a more severe wound status. Each of the 13 item scores ranged from 1 to 5 possible points. Minimum score of 13 indicated the best outcome, maximum score of 65 indicated the worst outcome. | Screening through Visit 8 (12 weeks) | 
| Braden Scale for Predicting Pressure Sore Risk - Total Score | The Braden Scale, performed by the Investigator (or designee), is a 6-item questionnaire (sensory perception, moisture, activity, mobility, nutrition, and friction &shear) used to assess the subject's level of risk for development of pressure ulcers. Total score is determined by adding together the sub-scores from each of the 6 items, with a lower score indicating a higher risk for developing pressure ulcers. Braden Scale thresholds: 19-23 = not at risk 15-18 = preventative interventions 13-14 = moderate risk 10-12 = high risk 6-9 = very high risk Sub-score ranges: Sensory perception: 1 - 4 Moisture: 1 - 4 Activity: 1 - 4 Mobility: 1 - 4 Nutrition: 1 - 4 Friction & Shear: 1 - 3 Total score minimum of 6 indicated a very high risk outcome, maximum score of 23 indicated the subject not at risk. | Screening through Visit 8 (12 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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wound healing, debridement, post-debridement, infection, prevention, wound, wound tissue, wound management, WoundWand, wound size reduction, wound bed debridement, WoundWand Debridement Device, chronic wound, delayed healing, cellular senescence, acute wound, diabetic foot ulcer, venous leg ulcers, radiofrequency debridement, necrotic tissue, skin