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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by ArthroCare Corporation
Sponsor:
Information provided by (Responsible Party):
ArthroCare Corporation
ClinicalTrials.gov Identifier:
NCT01924806
First received: August 13, 2013
Last updated: April 28, 2014
Last verified: April 2014
  Purpose

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


Condition Intervention
Chronic and Acute Wounds, Diabetic Foot Ulcers and Venous Leg Ulcers Below the Knee
Device: WoundWand™ Debridement Device
Device: Standard of Care sharp debridement

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Pilot Study of the WoundWand™ Debridement Device on Infection Prevention

Resource links provided by NLM:


Further study details as provided by ArthroCare Corporation:

Primary Outcome Measures:
  • bacterial diversity and number of bacteria [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    The primary endpoint is to determine the 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


Secondary Outcome Measures:
  • Reduction in wound size [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    a) Reduction in wound size for up to 12 weeks post-debridement

  • Health economic data [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    b) Health Economic data relating to the surgery (i.e., operating room time, surgical time), length of stay, admission, discharge, return to normal activities, medications, investigation site visits, and other related intervention and procedural costs and billing information may be collected when available

  • Wound closure [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    c) Incidence of complete wound closure within 12 weeks post-debridement


Estimated Enrollment: 60
Study Start Date: December 2013
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: WoundWand™ Debridement Device
Group I - Electrical energy that removes necrotic, ischemic, and/or infected tissue within a wound
Device: WoundWand™ Debridement Device
Group I - Electrical energy that removes necrotic, ischemic, and/or infected tissue within a wound
Active Comparator: Standard of Care sharp debridement
Group II - Sharp instruments that remove necrotic, ischemic, and/or infected tissue within a wound
Device: Standard of Care sharp debridement
Group II - Sharp instruments that remove necrotic, ischemic, and/or infected tissue within a wound

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01924806

Locations
France
Hopital Lapeyronie Not yet recruiting
Montpellier, France
Principal Investigator: Luc Teot, M.D., Phd.         
United Kingdom
Manchester Diabetes Centre Recruiting
Manchester, United Kingdom, M13 0JE
Contact: Stephanie Yau    0161-701-0168    stephanie.yau@cmft.nhs.uk   
Principal Investigator: Frank Bowling, Ph.D, FFPM, RCPS         
Sponsors and Collaborators
ArthroCare Corporation
Investigators
Principal Investigator: Luc Teot, M.D. Phd. Hopital Lapeyronie
  More Information

No publications provided

Responsible Party: ArthroCare Corporation
ClinicalTrials.gov Identifier: NCT01924806     History of Changes
Other Study ID Numbers: WW-2013-02
Study First Received: August 13, 2013
Last Updated: April 28, 2014
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by ArthroCare Corporation:
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

Additional relevant MeSH terms:
Infection
Ulcer
Diabetic Foot
Foot Ulcer
Leg Ulcer
Varicose Ulcer
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases
Varicose Veins

ClinicalTrials.gov processed this record on September 18, 2014