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

Primary Purpose

Lower Leg Wound

Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
WoundWand™ Debridement Device
Standard of Care sharp debridement
Sponsored by
Smith & Nephew, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lower Leg Wound focused on measuring 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, wound healing, skin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria

Subjects who meet the following criteria may be included in the clinical investigation, if they present with ALL of the following:

  1. Subject is able to understand the evaluation and willing to consent and comply with all post-debridement visits and procedures
  2. Age 18 years and older. Subjects may be of either sex and of any race or skin type

  3. Subjects fulfilling any one or all of the following criteria:

    1. chronic wound(s) below the level of the knee, defined by delayed healing or cellular senescence
    2. acute wound(s) as a result of a surgical procedure, laceration, abrasion or trauma
    3. diabetic foot ulcer(s)
    4. 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)

  4. Subjects with the following lab results within 30 days of treatment:

    1. serum albumin level >20g/L
    2. clinically non significant results of liver function test (LFTs), serum glucose and complete blood count (CBC) with differential
  5. Subjects with a Braden Score ≥13-14 (Moderate Risk)
  6. 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:

  1. Subjects that have tunneling wounds

  2. Subject presents with an active infection in the study wound, as defined by purulence and:

    1. Fever and leukocytosis

      OR any TWO of the following:

    2. Malodor, pain or tenderness, warmth, erythema, induration, swelling, lymphangitis
  3. Infected bone diagnosed by imaging modality (e.g., Magnetic Resonance Imaging (MRI) and/or radiographic images)
  4. Subjects whose study wound does not require debridement
  5. Cardiac pacemaker or other electronic implant(s)
  6. Subjects with irradiate, burn or ischaemic wounds or history of keloids
  7. Subjects with vasculitis, non-reconstructive peripheral vascular disease, pyoderma gangrenosum, renal failure or lymphoedema
  8. Subjects with uncontrolled bleeding disorder (PT/PTT) and coagulopathy (including those with hemophilia)

  9. Subjects taking treatment with any of the following:

    1. Systemic corticosteroids
    2. Immunosuppressive agent(s)
    3. Chemotherapy or Radiation therapy
  10. Subjects deemed to require biologic dressing/ skin substitute
  11. Terminally ill subjects
  12. 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)
  13. Subjects that have chronic skin conditions such as psoriasis, etc.
  14. Subjects that reside in a nursing home
  15. 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
  16. Subject is pregnant and/or intending to become pregnant during this clinical investigation period
  17. 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
  18. Subject is excluded if they have received an investigational therapy or approved therapy for investigational use within 30 days of surgery
  19. 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

Sites / Locations

  • Hopital Lapeyronie
  • Manchester Diabetes Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

WoundWand™ Debridement Device

Standard of Care sharp debridement

Arm Description

Group I - Coblator IQTM Controller plus WoundWandTM Debridement Device. Electrical energy that removes necrotic, ischemic, and/or infected tissue within a wound.

Group II - Standard of Care (SoC) surgical (sharp) debridement. Sharp instruments that remove necrotic, ischemic, and/or infected tissue within a wound.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
August 13, 2013
Last Updated
February 13, 2020
Sponsor
Smith & Nephew, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01924806
Brief Title
A Pilot Study of the WoundWand™ Debridement Device on Infection Prevention
Acronym
WoundWand
Official Title
A Pilot Study of the WoundWand™ Debridement Device on Infection Prevention
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Terminated
Why Stopped
Lower than expected accrual rate and desire to reassess overall study strategy.
Study Start Date
March 4, 2014 (Actual)
Primary Completion Date
February 9, 2015 (Actual)
Study Completion Date
February 9, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Smith & Nephew, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
A Pilot Study of the WoundWand™ Debridement Device on Infection Prevention
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lower Leg Wound
Keywords
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, wound healing, skin

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
WoundWand™ Debridement Device
Arm Type
Active Comparator
Arm Description
Group I - Coblator IQTM Controller plus WoundWandTM Debridement Device. Electrical energy that removes necrotic, ischemic, and/or infected tissue within a wound.
Arm Title
Standard of Care sharp debridement
Arm Type
Active Comparator
Arm Description
Group II - Standard of Care (SoC) surgical (sharp) debridement. Sharp instruments that remove necrotic, ischemic, and/or infected tissue within a wound.
Intervention Type
Device
Intervention Name(s)
WoundWand™ Debridement Device
Intervention Description
Group I - Electrical energy that removes necrotic, ischemic, and/or infected tissue within a wound
Intervention Type
Device
Intervention Name(s)
Standard of Care sharp debridement
Intervention Description
Group II - Sharp instruments that remove necrotic, ischemic, and/or infected tissue within a wound
Primary Outcome Measure Information:
Title
Bacterial Diversity and Number of Bacteria Present in the Wound
Description
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
Time Frame
Day 1 (immediately pre- and post-debridement) and 4 weeks post-debridement
Secondary Outcome Measure Information:
Title
Photograph Area Measurements to Determine Reduction in Wound Size
Description
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.
Time Frame
Visit 2 through Visit 8 (12 weeks)
Title
Wound Status Using Bates-Jensen Wound Assessment - Total Score
Description
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.
Time Frame
Screening through Visit 8 (12 weeks)
Title
Braden Scale for Predicting Pressure Sore Risk - Total Score
Description
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.
Time Frame
Screening through Visit 8 (12 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luc Teot, M.D. Phd.
Organizational Affiliation
Hopital Lapeyronie
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Beate Hanson, MD, PhD
Organizational Affiliation
Vice President, Global Clinical Strategy
Official's Role
Study Chair
Facility Information:
Facility Name
Hopital Lapeyronie
City
Montpellier
Country
France
Facility Name
Manchester Diabetes Centre
City
Manchester
ZIP/Postal Code
M13 0JE
Country
United Kingdom

12. IPD Sharing Statement

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

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