A Pilot Study of the WoundWand™ Debridement Device on Infection Prevention
Study Details
Study Description
Brief Summary
A Pilot Study of the WoundWand™ Debridement Device on Infection Prevention
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: 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. |
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 - 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
Group II - Sharp instruments that remove necrotic, ischemic, and/or infected tissue within a wound
|
Outcome Measures
Primary Outcome Measures
- Bacterial Diversity and Number of Bacteria Present in the Wound [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
Secondary Outcome Measures
- Photograph Area Measurements to Determine Reduction in Wound Size [Visit 2 through Visit 8 (12 weeks)]
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 [Screening through Visit 8 (12 weeks)]
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 [Screening through Visit 8 (12 weeks)]
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.
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hopital Lapeyronie | Montpellier | France | ||
| 2 | Manchester Diabetes Centre | Manchester | United Kingdom | M13 0JE |
Sponsors and Collaborators
- Smith & Nephew, Inc.
Investigators
- Principal Investigator: Luc Teot, M.D. Phd., Hopital Lapeyronie
- Study Chair: Beate Hanson, MD, PhD, Vice President, Global Clinical Strategy
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- WW-2013-02
Study Results
Participant Flow
| Recruitment Details | Sixty (60) subjects were to be randomized in a 1:1 ratio. A total of 11 subjects were enrolled at 1 investigative site by 2 investigators. |
|---|---|
| Pre-assignment Detail | Overall, 9 subjects received treatment for a total of 9 wounds treated. Two of the enrolled subjects, discontinued prior to treatment. |
| Arm/Group Title | WoundWand™ Debridement Device | Standard of Care Sharp Debridement |
|---|---|---|
| Arm/Group Description | WoundWand™ Debridement Device: Group I - Electrical energy that removes necrotic, ischemic, and/or infected tissue within a wound. ArthroCare developed COBLATION® technology, which uses a controlled, non-heat drive process (i.e., radiofrequency energy) to gently and precisely dissolve soft tissue, thereby minimizing damage to healthy tissue. ArthroCare adapted this technology for use in wound debridement via the WoundWand Debridement Device. | Standard of Care sharp debridement: Group II - Sharp instruments that remove necrotic, ischemic, and/or infected tissue within a wound. Surgical or sharp debridement is one of the methods commonly used to remove necrotic tissue from non-healing and difficult-to-heal chronic wounds. Surgical debridement requires sterile instruments and a qualified clinician in addition to general or local anesthesia. |
| Period Title: Overall Study | ||
| STARTED | 5 | 4 |
| COMPLETED | 3 | 3 |
| NOT COMPLETED | 2 | 1 |
Baseline Characteristics
| Arm/Group Title | WoundWand™ Debridement Device | Standard of Care Sharp Debridement | Total |
|---|---|---|---|
| Arm/Group Description | WoundWand™ Debridement Device: Group I - Electrical energy that removes necrotic, ischemic, and/or infected tissue within a wound. ArthroCare developed COBLATION® technology, which uses a controlled, non-heat drive process (i.e., radiofrequency energy) to gently and precisely dissolve soft tissue, thereby minimizing damage to healthy tissue. ArthroCare adapted this technology for use in wound debridement via the WoundWand Debridement Device. | Standard of Care sharp debridement: Group II - Sharp instruments that remove necrotic, ischemic, and/or infected tissue within a wound. Surgical or sharp debridement is one of the methods commonly used to remove necrotic tissue from non-healing and difficult-to-heal chronic wounds. Surgical debridement requires sterile instruments and a qualified clinician in addition to general or local anesthesia. | Total of all reporting groups |
| Overall Participants | 5 | 4 | 9 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
66.4
(8.6)
|
68.8
(13.6)
|
67.8
(10.4)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
1
20%
|
1
25%
|
2
22.2%
|
| Male |
4
80%
|
3
75%
|
7
77.8%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
0
0%
|
0
0%
|
0
0%
|
| Not Hispanic or Latino |
5
100%
|
4
100%
|
9
100%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
1
20%
|
0
0%
|
1
11.1%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
0
0%
|
0
0%
|
0
0%
|
| White |
4
80%
|
4
100%
|
8
88.9%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Region of Enrollment (participants) [Number] | |||
| United Kingdom |
5
100%
|
4
100%
|
9
100%
|
| Etiology of Study Wound (Count of Participants) | |||
| Pressure |
2
40%
|
2
50%
|
4
44.4%
|
| Pressure and Neuropathy |
0
0%
|
1
25%
|
1
11.1%
|
| Infection |
1
20%
|
0
0%
|
1
11.1%
|
| Infection, Trauma and Neuropathy |
0
0%
|
1
25%
|
1
11.1%
|
| Laceration |
0
0%
|
0
0%
|
0
0%
|
| Abrasion |
0
0%
|
0
0%
|
0
0%
|
| Trauma |
0
0%
|
0
0%
|
0
0%
|
| Surgical Procedure |
0
0%
|
0
0%
|
0
0%
|
| Surgical Procedure and Underlying Condition |
1
20%
|
0
0%
|
1
11.1%
|
| Vascular Insufficiency |
1
20%
|
0
0%
|
1
11.1%
|
| Neuropathy |
0
0%
|
0
0%
|
0
0%
|
| Underlying Condition |
0
0%
|
0
0%
|
0
0%
|
| Other |
0
0%
|
0
0%
|
0
0%
|
| Type of Wound (Count of Participants) | |||
| Chronic |
0
0%
|
1
25%
|
1
11.1%
|
| Chronic and Diabetic Foot Ulcer |
0
0%
|
2
50%
|
2
22.2%
|
| Acute |
0
0%
|
0
0%
|
0
0%
|
| Diabetic Foot Ulcer |
5
100%
|
1
25%
|
6
66.7%
|
| Venous Leg Ulcer |
0
0%
|
0
0%
|
0
0%
|
Outcome Measures
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All treated subjects |
| Arm/Group Title | WoundWand™ Debridement Device | Standard of Care Sharp Debridement |
|---|---|---|
| Arm/Group Description | WoundWand™ Debridement Device: Group I - Electrical energy that removes necrotic, ischemic, and/or infected tissue within a wound. ArthroCare developed COBLATION® technology, which uses a controlled, non-heat drive process (i.e., radiofrequency energy) to gently and precisely dissolve soft tissue, thereby minimizing damage to healthy tissue. ArthroCare adapted this technology for use in wound debridement via the WoundWand Debridement Device. | Standard of Care sharp debridement: Group II - Sharp instruments that remove necrotic, ischemic, and/or infected tissue within a wound. Surgical or sharp debridement is one of the methods commonly used to remove necrotic tissue from non-healing and difficult-to-heal chronic wounds. Surgical debridement requires sterile instruments and a qualified clinician in addition to general or local anesthesia. |
| Measure Participants | 5 | 4 |
| Subject 02-001 - Total Aerobes/Pre |
7.74
|
|
| 02-001 - Total Aerobes/Post |
7.25
|
|
| 02-001 - Total Aerobes/Week 4 |
6.29
|
|
| Subject 02-002 - Total Aerobes/Pre |
8.37
|
|
| 02-002 - Total Aerobes/Post |
7.05
|
|
| 02-002 - Total Aerobes/Week 4 |
5.31
|
|
| Subject 02-003 - Total Aerobes/Pre |
9.14
|
|
| 02-003 - Total Aerobes/Post |
4.38
|
|
| 02-003 - Total Aerobes/Week 4 |
6.67
|
|
| Subject 02-004 - Total Aerobes/Pre |
5.99
|
|
| 02-004 - Total Aerobes/Post |
4.91
|
|
| 02-004 - Total Aerobes/Week 4 |
7.70
|
|
| Subject 02-005 - Total Aerobes/Pre |
8.46
|
|
| 02-005 - Total Aerobes/Post |
6.75
|
|
| 02-005 - Total Aerobes/Week 4 |
6.38
|
|
| Subject 02-007 - Total Aerobes/Pre |
7.42
|
|
| 02-007 - Total Aerobes/Post |
5.12
|
|
| 02-007 - Total Aerobes/Week 4 |
8.08
|
|
| Subject 02-008 - Total Aerobes/Pre |
7.84
|
|
| 02-008 - Total Aerobes/Post |
7.41
|
|
| 02-008 - Total Aerobes/Week 4 |
4.09
|
|
| Subject 02-009 - Total Aerobes/Pre |
6.90
|
|
| 02-009 - Total Aerobes/Post |
4.41
|
|
| 02-009 - Total Aerobes/Week 4 |
8.56
|
|
| Subject 02-010 - Total Aerobes/Pre |
7.30
|
|
| 02-010 - Total Aerobes/Post |
7.24
|
|
| 02-010 - Total Aerobes/Week 4 |
8.79
|
|
| Subject 02-001 - Total Gram Positive Anaerobes/Pre |
7.66
|
|
| 02-001 - Total Gram + Anaerobes/Post |
5.25
|
|
| 02-001 - Total Gram + Anaerobes/Week 4 |
5.66
|
|
| Subject 02-002 - Total Gram Positive Anaerobes/Pre |
8.50
|
|
| 02-002 - Total Gram + Anaerobes/Post |
7.05
|
|
| 02-002 - Total Gram + Anaerobes/Week 4 |
3.83
|
|
| Subject 02-003 - Total Gram Positive Anaerobes/Pre |
8.66
|
|
| 02-003 - Total Gram + Anaerobes/Post |
3.36
|
|
| 02-003 - Total Gram + Anaerobes/Week 4 |
7.60
|
|
| Subject 02-004 - Total Gram Positive Anaerobes/Pre |
5.02
|
|
| 02-004 - Total Gram + Anaerobes/Post |
3.80
|
|
| 02-004 - Total Gram + Anaerobes/Week 4 |
6.43
|
|
| Subject 02-005 - Total Gram Positive Anaerobes/Pre |
7.42
|
|
| 02-005 - Total Gram + Anaerobes/Post |
5.58
|
|
| 02-005 - Total Gram + Anaerobes/Week 4 |
4.56
|
|
| Subject 02-007 - Total Gram Positive Anaerobes/Pre |
5.28
|
|
| 02-007 - Total Gram + Anaerobes/Post |
3.29
|
|
| 02-007 - Total Gram + Anaerobes/Week 4 |
3.92
|
|
| Subject 02-008 - Total Gram Positive Anaerobes/Pre |
7.61
|
|
| 02-008 - Total Gram + Anaerobes/Post |
7.41
|
|
| 02-008 - Total Gram + Anaerobes/Week 4 |
0.00
|
|
| Subject 02-009 - Total Gram Positive Anaerobes/Pre |
4.28
|
|
| 02-009 - Total Gram + Anaerobes/Post |
0.00
|
|
| 02-009 - Total Gram + Anaerobes/Week 4 |
8.70
|
|
| Subject 02-010 - Total Gram Positive Anaerobes/Pre |
4.30
|
|
| 02-010 - Total Gram + Anaerobes/Post |
3.15
|
|
| 02-010 - Total Gram + Anaerobes/Week 4 |
7.66
|
|
| Subject 02-001 - Total Gram Negative Anaerobes/Pre |
6.98
|
|
| 02-001 - Total Gram - Anaerobes/Post |
3.21
|
|
| 02-001 - Total Gram - Anaerobes/Week 4 |
4.80
|
|
| Subject 02-002 - Total Gram Negative Anaerobes/Pre |
7.30
|
|
| 02-002 - Total Gram - Anaerobes/Post |
5.57
|
|
| 02-002 - Total Gram - Anaerobes/Week 4 |
4.75
|
|
| Subject 02-003 - Total Gram Negative Anaerobes/Pre |
8.90
|
|
| 02-003 - Total Gram - Anaerobes/Post |
3.70
|
|
| 02-003 - Total Gram - Anaerobes/Week 4 |
0.00
|
|
| Subject 02-004 - Total Gram Negative Anaerobes/Pre |
0.00
|
|
| 02-004 - Total Gram - Anaerobes/Post |
0.00
|
|
| 02-004 - Total Gram - Anaerobes/Week 4 |
5.88
|
|
| Subject 02-005 - Total Gram Negative Anaerobes/Pre |
6.54
|
|
| 02-005 - Total Gram - Anaerobes/Post |
5.59
|
|
| 02-005 - Total Gram - Anaerobes/Week 4 |
6.30
|
|
| Subject 02-007 - Total Gram Negative Anaerobes/Pre |
7.54
|
|
| 02-007 - Total Gram - Anaerobes/Post |
5.13
|
|
| 02-007 - Total Gram - Anaerobes/Week 4 |
7.89
|
|
| Subject 02-008 - Total Gram Negative Anaerobes/Pre |
3.31
|
|
| 02-008 - Total Gram - Anaerobes/Post |
0.00
|
|
| 02-008 - Total Gram - Anaerobes/Week 4 |
0.00
|
|
| Subject 02-009 - Total Gram Negative Anaerobes/Pre |
5.82
|
|
| 02-009 - Total Gram - Anaerobes/Post |
3.96
|
|
| 02-009 - Total Gram - Anaerobes/Week 4 |
3.59
|
|
| Subject 02-010 - Total Gram Negative Anaerobes/Pre |
5.73
|
|
| 02-010 - Total Gram - Anaerobes/Post |
6.07
|
|
| 02-010 - Total Gram - Anaerobes/Week 4 |
8.62
|
|
| Subject 02-001 - Total Staphylococci/Pre |
7.11
|
|
| 02-001 - Total Staph/Post |
4.56
|
|
| 02-001 - Total Staph/Week 4 |
0.00
|
|
| Subject 02-002 - Total Staphylococci/Pre |
6.39
|
|
| 02-002 - Total Staph/Post |
5.92
|
|
| 02-002 - Total Staph/Week 4 |
0.00
|
|
| Subject 02-003 - Total Staphylococci/Pre |
8.75
|
|
| 02-003 - Total Staph/Post |
4.38
|
|
| 02-003 - Total Staph/Week 4 |
6.70
|
|
| Subject 02-004 - Total Staphylococci/Pre |
5.15
|
|
| 02-004 - Total Staph/Post |
3.25
|
|
| 02-004 - Total Staph/Week 4 |
7.55
|
|
| Subject 02-005 - Total Staphylococci/Pre |
8.37
|
|
| 02-005 - Total Staph/Post |
6.67
|
|
| 02-005 - Total Staph/Week 4 |
6.69
|
|
| Subject 02-007 - Total Staphylococci/Pre |
0.00
|
|
| 02-007 - Total Staph/Post |
0.00
|
|
| 02-007 - Total Staph/Week 4 |
3.93
|
|
| Subject 02-008 - Total Staphylococci/Pre |
7.24
|
|
| 02-008 - Total Staph/Post |
5.93
|
|
| 02-008 - Total Staph/Week 4 |
3.43
|
|
| Subject 02-009 - Total Staphylococci/Pre |
6.97
|
|
| 02-009 - Total Staph/Post |
4.64
|
|
| 02-009 - Total Staph/Week 4 |
8.47
|
|
| Subject 02-010 - Total Staphylococci/Pre |
7.05
|
|
| 02-010 - Total Staph/Post |
6.87
|
|
| 02-010 - Total Staph/Week 4 |
8.15
|
|
| Subject 02-001 - Total S. aureus/Pre |
0.00
|
|
| 02-001 - Total S. aureus/Post |
0.00
|
|
| 02-001 - Total S. aureus/Week 4 |
0.00
|
|
| Subject 02-002 - Total S. aureus/Pre |
0.00
|
|
| 02-002 - Total S. aureus/Post |
0.00
|
|
| 02-002 - Total S. aureus/Week 4 |
0.00
|
|
| Subject 02-003 - Total S. aureus/Pre |
0.00
|
|
| 02-003 - Total S. aureus/Post |
0.00
|
|
| 02-003 - Total S. aureus/Week 4 |
6.58
|
|
| Subject 02-004 - Total S. aureus/Pre |
0.00
|
|
| 02-004 - Total S. aureus/Post |
0.00
|
|
| 02-004 - Total S. aureus/Week 4 |
0.00
|
|
| Subject 02-005 - Total S. aureus/Pre |
0.00
|
|
| 02-005 - Total S. aureus/Post |
0.00
|
|
| 02-005 - Total S. aureus/Week 4 |
0.00
|
|
| Subject 02-007 - Total S. aureus/Pre |
0.00
|
|
| 02-007 - Total S. aureus/Post |
0.00
|
|
| 02-007 - Total S. aureus/Week 4 |
0.00
|
|
| Subject 02-008 - Total S. aureus/Pre |
6.89
|
|
| 02-008 - Total S. aureus/Post |
5.49
|
|
| 02-008 - Total S. aureus/Week 4 |
0.00
|
|
| Subject 02-009 - Total S. aureus/Pre |
0.00
|
|
| 02-009 - Total S. aureus/Post |
0.00
|
|
| 02-009 - Total S. aureus/Week 4 |
0.00
|
|
| Subject 02-010 - Total S. aureus/Pre |
0.00
|
|
| 02-010 - Total S. aureus/Post |
0.00
|
|
| 02-010 - Total S. aureus/Week 4 |
0.00
|
|
| Subject 02-001 - Total Coliforms/Pre |
6.83
|
|
| 02-001 - Total Coliforms/Post |
3.53
|
|
| 02-001 - Total Coliforms/Week 4 |
0.00
|
|
| Subject 02-002 - Total Coliforms/Pre |
6.84
|
|
| 02-002 - Total Coliforms/Post |
5.58
|
|
| 02-002 - Total Coliforms/Week 4 |
4.68
|
|
| Subject 02-003 - Total Coliforms/Pre |
0.00
|
|
| 02-003 - Total Coliforms/Post |
0.00
|
|
| 02-003 - Total Coliforms/Week 4 |
0.00
|
|
| Subject 02-004 - Total Coliforms/Pre |
0.00
|
|
| 02-004 - Total Coliforms/Post |
0.00
|
|
| 02-004 - Total Coliforms/Week 4 |
4.23
|
|
| Subject 02-005 - Total Coliforms/Pre |
6.50
|
|
| 02-005 - Total Coliforms/Post |
5.56
|
|
| 02-005 - Total Coliforms/Week 4 |
6.26
|
|
| Subject 02-007 - Total Coliforms/Pre |
7.33
|
|
| 02-007 - Total Coliforms/Post |
4.99
|
|
| 02-007 - Total Coliforms/Week 4 |
4.57
|
|
| Subject 02-008 - Total Coliforms/Pre |
7.75
|
|
| 02-008 - Total Coliforms/Post |
7.37
|
|
| 02-008 - Total Coliforms/Week 4 |
0.00
|
|
| Subject 02-009 - Total Coliforms/Pre |
0.00
|
|
| 02-009 - Total Coliforms/Post |
0.00
|
|
| 02-009 - Total Coliforms/Week 4 |
0.00
|
|
| Subject 02-010 - Total Coliforms/Pre |
7.14
|
|
| 02-010 - Total Coliforms/Post |
6.89
|
|
| 02-010 - Total Coliforms/Week 4 |
8.24
|
|
| Subject 02-001 - Total Pseudomonads/Pre |
0.00
|
|
| 02-001 - Total Pseudomonads/Post |
0.00
|
|
| 02-001 - Total Pseudomonads/Week 4 |
0.00
|
|
| Subject 02-002 - Total Pseudomonads/Pre |
0.00
|
|
| 02-002 - Total Pseudomonads/Post |
0.00
|
|
| 02-002 - Total Pseudomonads/Week 4 |
0.00
|
|
| Subject 02-003 - Total Pseudomonads/Pre |
0.00
|
|
| 02-003 - Total Pseudomonads/Post |
0.00
|
|
| 02-003 - Total Pseudomonads/Week 4 |
0.00
|
|
| Subject 02-004 - Total Pseudomonads/Pre |
5.89
|
|
| 02-004 - Total Pseudomonads/Post |
4.87
|
|
| 02-004 - Total Pseudomonads/Week 4 |
4.43
|
|
| Subject 02-005 - Total Pseudomonads/Pre |
0.00
|
|
| 02-005 - Total Pseudomonads/Post |
0.00
|
|
| 02-005 - Total Pseudomonads/Week 4 |
0.00
|
|
| Subject 02-007 - Total Pseudomonads/Pre |
0.00
|
|
| 02-007 - Total Pseudomonads/Post |
0.00
|
|
| 02-007 - Total Pseudomonads/Week 4 |
0.00
|
|
| Subject 02-008 - Total Pseudomonads/Pre |
0.00
|
|
| 02-008 - Total Pseudomonads/Post |
0.00
|
|
| 02-008 - Total Pseudomonads/Week 4 |
0.00
|
|
| Subject 02-009 - Total Pseudomonads/Pre |
0.00
|
|
| 02-009 - Total Pseudomonads/Post |
0.00
|
|
| 02-009 - Total Pseudomonads/Week 4 |
0.00
|
|
| Subject 02-010 - Total Pseudomonads/Pre |
0.00
|
|
| 02-010 - Total Pseudomonads/Post |
0.00
|
|
| 02-010 - Total Pseudomonads/Week 4 |
0.00
|
|
| Subject 02-001 - Total Strep/Pre |
0.00
|
|
| 02-001 - Total Strep/Post |
0.00
|
|
| 02-001 - Total Strep/Week 4 |
0.00
|
|
| Subject 02-002 - Total Strep/Pre |
0.00
|
|
| 02-002 - Total Strep/Post |
0.00
|
|
| 02-002 - Total Strep/Week 4 |
0.00
|
|
| Subject 02-003 - Total Strep/Pre |
0.00
|
|
| 02-003 - Total Strep/Post |
0.00
|
|
| 02-003 - Total Strep/Week 4 |
0.00
|
|
| Subject 02-004 - Total Strep/Pre |
0.00
|
|
| 02-004 - Total Strep/Post |
0.00
|
|
| 02-004 - Total Strep/Week 4 |
0.00
|
|
| Subject 02-005 - Total Strep/Pre |
0.00
|
|
| 02-005 - Total Strep/Post |
0.00
|
|
| 02-005 - Total Strep/Week 4 |
0.00
|
|
| Subject 02-007 - Total Strep/Pre |
0.00
|
|
| 02-007 - Total Strep/Post |
0.00
|
|
| 02-007 - Total Strep/Week 4 |
0.00
|
|
| Subject 02-008 - Total Strep/Pre |
0.00
|
|
| 02-008 - Total Strep/Post |
0.00
|
|
| 02-008 - Total Strep/Week 4 |
0.00
|
|
| Subject 02-009 - Total Strep/Pre |
0.00
|
|
| 02-009 - Total Strep/Post |
0.00
|
|
| 02-009 - Total Strep/Week 4 |
0.00
|
|
| Subject 02-010 - Total Strep/Pre |
0.00
|
|
| 02-010 - Total Strep/Post |
0.00
|
|
| 02-010 - Total Strep/Week 4 |
0.00
|
| 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All treated subjects |
| Arm/Group Title | WoundWand™ Debridement Device | Standard of Care Sharp Debridement |
|---|---|---|
| Arm/Group Description | WoundWand™ Debridement Device: Group I - Electrical energy that removes necrotic, ischemic, and/or infected tissue within a wound. ArthroCare developed COBLATION® technology, which uses a controlled, non-heat drive process (i.e., radiofrequency energy) to gently and precisely dissolve soft tissue, thereby minimizing damage to healthy tissue. ArthroCare adapted this technology for use in wound debridement via the WoundWand Debridement Device. | Standard of Care sharp debridement: Group II - Sharp instruments that remove necrotic, ischemic, and/or infected tissue within a wound. Surgical or sharp debridement is one of the methods commonly used to remove necrotic tissue from non-healing and difficult-to-heal chronic wounds. Surgical debridement requires sterile instruments and a qualified clinician in addition to general or local anesthesia. |
| Measure Participants | 5 | 4 |
| Subject 02-001 Visit 2/Pre Debridement |
NA
|
|
| 02-001 Visit 2/Post Debridement |
80.24
|
|
| 02-001 Visit 3/Week 1 |
57.24
|
|
| 02-001 Visit 4/Week 2 |
58.36
|
|
| 02-001 Visit 5/Week 3 |
50.15
|
|
| 02-001 Visit 6/Week 4 |
52.12
|
|
| 02-001 Visit 7/Week 6 |
35.61
|
|
| 02-001 Visit 7/Week 6 measurement 2 |
29.70
|
|
| 02-001 Visit 8/Week 12 |
17.84
|
|
| Subject 02-002 Visit 2/Pre Debridement |
41.80
|
|
| 02-002 Visit 2/Post Debridement |
NA
|
|
| 02-002 Visit 3/Week 1 |
53.59
|
|
| 02-002 Visit 4/Week 2 |
30.03
|
|
| 02-002 Visit 5/Week 3 |
40.08
|
|
| 02-002 Visit 6/Week 4 |
31.73
|
|
| 02-002 Visit 7/Week 6 |
37.43
|
|
| 02-002 Visit 7/Week 6 measurement 2 |
33.99
|
|
| 02-002 Visit 8/Week 12 |
22.79
|
|
| Subject 02-003 Visit 2/Pre Debridement |
6.80
|
|
| 02-003 Visit 2/Post Debridement |
9.34
|
|
| 02-003 Visit 3/Week 1 |
6.25
|
|
| 02-003 Visit 4/Week 2 |
6.29
|
|
| 02-003 Visit 4/Week 2 measurement 2 |
9.18
|
|
| 02-003 Visit 5/Week 3 |
2.88
|
|
| 02-003 Visit 6/Week 4 |
3.05
|
|
| 02-003 Visit 7/Week 6 |
3.99
|
|
| 02-003 Visit 8/Week 12 |
1.43
|
|
| Subject 02-004 Visit 2/Pre Debridement |
2.37
|
|
| 02-004 Visit 2/Post Debridement |
0.59
|
|
| 02-004 Visit 3/Week 1 |
1.25
|
|
| 02-004 Visit 3/Week 1 measurement 2 |
1.35
|
|
| 02-004 Visit 4/Week 2 |
1.02
|
|
| 02-004 Visit 5/Week 3 |
1.84
|
|
| 02-004 Visit 6/Week 4 |
2.41
|
|
| 02-004 Visit 7/Week 6 |
0.42
|
|
| 02-004 Visit 8/Week 12 |
0.33
|
|
| Subject 02-005 Visit 2/Pre Debridement |
16.20
|
|
| 02-005 Visit 2/Post Debridement |
28.74
|
|
| 02-005 Visit 3/Week 1 |
19.53
|
|
| 02-005 Visit 3/Week 1 measurement 2 |
19.98
|
|
| 02-005 Visit 4/Week 2 |
23.67
|
|
| 02-005 Visit 5/Week 3 |
22.16
|
|
| 02-005 Visit 6/Week 4 |
21.40
|
|
| 02-005 Visit 7/Week 6 |
34.06
|
|
| 02-005 Visit 8/Week 12 |
26.56
|
|
| Subject 02-007 Visit 2/Pre Debridement |
23.56
|
|
| 02-007 Visit 2/Pre Debridement |
25.87
|
|
| 02-007 Visit 2/Post Debridement |
NA
|
|
| 02-007 Visit 3/Week 1 |
26.91
|
|
| 02-007 Visit 4/Week 2 |
23.02
|
|
| 02-007 Visit 5/Week 3 |
24.89
|
|
| 02-007 Visit 6/Week 4 |
28.04
|
|
| 02-007 Visit 7/Week 6 |
NA
|
|
| 02-007 Visit 8/Week 12 |
NA
|
|
| Subject 02-008 Visit 2/Pre Debridement |
29.53
|
|
| 02-008 Visit 2/Post Debridement |
86.16
|
|
| 02-008 Visit 3/Week 1 |
50.26
|
|
| 02-008 Visit 3/Week 1 measurement 2 |
85.47
|
|
| 02-008 Visit 4/Week 2 |
30.13
|
|
| 02-008 Visit 4/Week 2 measurement 2 |
72.20
|
|
| 02-008 Visit 5/Week 3 |
19.65
|
|
| 02-008 Visit 5/Week 3 measurement 2 |
33.32
|
|
| 02-008 Visit 6/Week 4 |
93.46
|
|
| 02-008 Visit 6/Week 4 measurement 2 |
24.75
|
|
| 02-008 Visit 7/Week 6 |
NA
|
|
| 02-008 Visit 8/Week 12 |
NA
|
|
| Subject 02-009 Visit 2/Pre Debridement |
50.49
|
|
| 02-009 Visit 2/Post Debridement |
35.05
|
|
| 02-009 Visit 3/Week 1 |
67.80
|
|
| 02-009 Visit 4/Week 2 |
26.84
|
|
| 02-009 Visit 5/Week 3 |
23.02
|
|
| 02-009 Visit 6/Week 4 |
38.27
|
|
| 02-009 Visit 7/Week 6 |
NA
|
|
| 02-009 Visit 8/Week 12 |
NA
|
|
| Subject 02-010 Visit 2/Pre Debridement |
9.03
|
|
| 02-010 Visit 2/Post Debridement |
9.39
|
|
| 02-010 Visit 3/Week 1 |
24.15
|
|
| 02-010 Visit 3/Week 1 measurement 2 |
6.55
|
|
| 02-010 Visit 4/Week 2 |
6.99
|
|
| 02-010 Visit 5/Week 3 |
5.08
|
|
| 02-010 Visit 6/Week 4 |
15.42
|
|
| 02-010 Visit 7/Week 6 |
NA
|
|
| 02-010 Visit 8/Week 12 |
NA
|
| 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All subjects seen and assessed at each time point. |
| Arm/Group Title | WoundWand™ Debridement Device | Standard of Care Sharp Debridement |
|---|---|---|
| Arm/Group Description | WoundWand™ Debridement Device: Group I - Electrical energy that removes necrotic, ischemic, and/or infected tissue within a wound. ArthroCare developed COBLATION® technology, which uses a controlled, non-heat drive process (i.e., radiofrequency energy) to gently and precisely dissolve soft tissue, thereby minimizing damage to healthy tissue. ArthroCare adapted this technology for use in wound debridement via the WoundWand Debridement Device. | Standard of Care sharp debridement: Group II - Sharp instruments that remove necrotic, ischemic, and/or infected tissue within a wound. Surgical or sharp debridement is one of the methods commonly used to remove necrotic tissue from non-healing and difficult-to-heal chronic wounds. Surgical debridement requires sterile instruments and a qualified clinician in addition to general or local anesthesia. |
| Measure Participants | 5 | 4 |
| Visit 1/Screening |
33.2
(3.1)
|
33.8
(4.8)
|
| Visit 2/Debridement |
35.2
(5.8)
|
33.3
(5.6)
|
| Visit 3/Week 1 |
31.0
(6.4)
|
34.0
(5.0)
|
| Visit 4/Week 2 |
27.8
(2.9)
|
33.3
(5.4)
|
| Visit 5/Week 3 |
25.2
(3.1)
|
33.3
(6.1)
|
| Visit 6/Week 4 |
25.5
(5.7)
|
32.3
(7.6)
|
| Visit 7/Week 6 |
18.7
(0.6)
|
31.0
(10.1)
|
| Visit 8/Week 12 |
16.0
(1.7)
|
31.0
(20.9)
|
| 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All available subjects at each time point. |
| Arm/Group Title | WoundWand™ Debridement Device | Standard of Care Sharp Debridement |
|---|---|---|
| Arm/Group Description | WoundWand™ Debridement Device: Group I - Electrical energy that removes necrotic, ischemic, and/or infected tissue within a wound. ArthroCare developed COBLATION® technology, which uses a controlled, non-heat drive process (i.e., radiofrequency energy) to gently and precisely dissolve soft tissue, thereby minimizing damage to healthy tissue. ArthroCare adapted this technology for use in wound debridement via the WoundWand Debridement Device. | Standard of Care sharp debridement: Group II - Sharp instruments that remove necrotic, ischemic, and/or infected tissue within a wound. Surgical or sharp debridement is one of the methods commonly used to remove necrotic tissue from non-healing and difficult-to-heal chronic wounds. Surgical debridement requires sterile instruments and a qualified clinician in addition to general or local anesthesia. |
| Measure Participants | 5 | 4 |
| Visit 1/Screening |
17.8
(2.6)
|
18.5
(3.1)
|
| Visit 3/Week 1 |
17.6
(2.9)
|
18.0
(2.2)
|
| Visit 4/Week 2 |
17.8
(3.1)
|
18.0
(2.2)
|
| Visit 5/Week 3 |
17.8
(3.6)
|
18.3
(2.9)
|
| Visit 6/Week 4 |
17.8
(2.8)
|
18.5
(3.3)
|
| Visit 7/Week 6 |
18.0
(1.7)
|
20.0
(4.4)
|
| Visit 8/Week 12 |
19.3
(3.8)
|
20.0
(4.4)
|
Adverse Events
| Time Frame | AEs were collected from the time of enrollment until study completion at 12 weeks post debridement, study withdrawal, or study termination, whichever came first. | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | WoundWand™ Debridement Device | Standard of Care Sharp Debridement | ||
| Arm/Group Description | Group I - Coblator IQTM Controller plus WoundWand™ Debridement Device. Electrical energy that removes necrotic, ischemic, and/or infected tissue within a wound. WoundWand™ Debridement Device: Group I - 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. Standard of Care sharp debridement: Group II - Sharp instruments that remove necrotic, ischemic, and/or infected tissue within a wound | ||
All Cause Mortality |
||||
| WoundWand™ Debridement Device | Standard of Care Sharp Debridement | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/5 (0%) | 0/4 (0%) | ||
Serious Adverse Events |
||||
| WoundWand™ Debridement Device | Standard of Care Sharp Debridement | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/5 (0%) | 0/4 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| WoundWand™ Debridement Device | Standard of Care Sharp Debridement | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 4/5 (80%) | 2/4 (50%) | ||
| Cardiac disorders | ||||
| 2:1 AV block and bradycardia | 1/5 (20%) | 1 | 0/4 (0%) | 0 |
| Infections and infestations | ||||
| Micro groin wound infection | 1/5 (20%) | 1 | 0/4 (0%) | 0 |
| Infection to wound | 0/5 (0%) | 0 | 1/4 (25%) | 1 |
| Chronic wound | 2/5 (40%) | 2 | 1/4 (25%) | 1 |
| Infection to foot ulcer | 1/5 (20%) | 1 | 0/4 (0%) | 0 |
| Serratia growth on bone | 1/5 (20%) | 1 | 0/4 (0%) | 0 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Henry Jaimes |
|---|---|
| Organization | Smith & Nephew |
| Phone | 01923-477-164 |
| henry.jaimes@smith-nephew.com |
- WW-2013-02