Lower than expected accrual rate and desire to reassess overall study strategy.

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

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.

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

All randomized subjects

AEs were collected from the time of enrollment until study completion at 12 weeks post debridement, study withdrawal, or study termination, whichever came first.

This study was terminated due to lower than anticipated accrual rate and the desire to reassess overall study strategy; therefore, statistically sound conclusions regarding safety, effectiveness, and risk/benefit profile of the device can't be made.