Trial Outcomes & Findings for A Pilot Study of the WoundWand™ Debridement Device on Infection Prevention (NCT NCT01924806)

NCT ID: NCT01924806

Last Updated: 2020-02-28

Results Overview

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

Recruitment status

TERMINATED

Study phase

Target enrollment

11 participants

Primary outcome timeframe

Day 1 (immediately pre- and post-debridement) and 4 weeks post-debridement

Results posted on

2020-02-28

Participant Flow

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.

Overall, 9 subjects received treatment for a total of 9 wounds treated. Two of the enrolled subjects, discontinued prior to treatment.

Unit of analysis: Wounds

Participant milestones

Participant milestones
Measure	WoundWand™ Debridement Device 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 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.
Overall Study STARTED	5 5	4 4
Overall Study COMPLETED	3 3	3 3
Overall Study NOT COMPLETED	2 2	1 1

Reasons for withdrawal

Reasons for withdrawal
Measure	WoundWand™ Debridement Device 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 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.
Overall Study Physician Decision	2	1

Baseline Characteristics

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

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Day 1 (immediately pre- and post-debridement) and 4 weeks post-debridement

Population: All treated subjects

Outcome measures

Outcome measures
Measure	WoundWand™ Debridement Device n=5 Participants 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 n=4 Participants 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.
Bacterial Diversity and Number of Bacteria Present in the Wound 02-005 - Total Gram + Anaerobes/Week 4	—	4.56 Log^10 CFU/g
Bacterial Diversity and Number of Bacteria Present in the Wound Subject 02-001 - Total Aerobes/Pre	7.74 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound 02-001 - Total Aerobes/Post	7.25 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound 02-001 - Total Aerobes/Week 4	6.29 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound Subject 02-002 - Total Aerobes/Pre	—	8.37 Log^10 CFU/g
Bacterial Diversity and Number of Bacteria Present in the Wound 02-002 - Total Aerobes/Post	—	7.05 Log^10 CFU/g
Bacterial Diversity and Number of Bacteria Present in the Wound 02-002 - Total Aerobes/Week 4	—	5.31 Log^10 CFU/g
Bacterial Diversity and Number of Bacteria Present in the Wound Subject 02-003 - Total Aerobes/Pre	9.14 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound 02-003 - Total Aerobes/Post	4.38 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound 02-003 - Total Aerobes/Week 4	6.67 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound Subject 02-004 - Total Aerobes/Pre	—	5.99 Log^10 CFU/g
Bacterial Diversity and Number of Bacteria Present in the Wound 02-004 - Total Aerobes/Post	—	4.91 Log^10 CFU/g
Bacterial Diversity and Number of Bacteria Present in the Wound 02-004 - Total Aerobes/Week 4	—	7.70 Log^10 CFU/g
Bacterial Diversity and Number of Bacteria Present in the Wound Subject 02-005 - Total Aerobes/Pre	—	8.46 Log^10 CFU/g
Bacterial Diversity and Number of Bacteria Present in the Wound 02-005 - Total Aerobes/Post	—	6.75 Log^10 CFU/g
Bacterial Diversity and Number of Bacteria Present in the Wound 02-005 - Total Aerobes/Week 4	—	6.38 Log^10 CFU/g
Bacterial Diversity and Number of Bacteria Present in the Wound Subject 02-007 - Total Aerobes/Pre	7.42 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound 02-007 - Total Aerobes/Post	5.12 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound 02-007 - Total Aerobes/Week 4	8.08 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound Subject 02-008 - Total Aerobes/Pre	—	7.84 Log^10 CFU/g
Bacterial Diversity and Number of Bacteria Present in the Wound 02-008 - Total Aerobes/Post	—	7.41 Log^10 CFU/g
Bacterial Diversity and Number of Bacteria Present in the Wound 02-008 - Total Aerobes/Week 4	—	4.09 Log^10 CFU/g
Bacterial Diversity and Number of Bacteria Present in the Wound Subject 02-009 - Total Aerobes/Pre	6.90 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound 02-009 - Total Aerobes/Post	4.41 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound 02-009 - Total Aerobes/Week 4	8.56 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound Subject 02-010 - Total Aerobes/Pre	7.30 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound 02-010 - Total Aerobes/Post	7.24 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound 02-010 - Total Aerobes/Week 4	8.79 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound Subject 02-001 - Total Gram Positive Anaerobes/Pre	7.66 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound 02-001 - Total Gram + Anaerobes/Post	5.25 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound 02-001 - Total Gram + Anaerobes/Week 4	5.66 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound Subject 02-002 - Total Gram Positive Anaerobes/Pre	—	8.50 Log^10 CFU/g
Bacterial Diversity and Number of Bacteria Present in the Wound 02-002 - Total Gram + Anaerobes/Post	—	7.05 Log^10 CFU/g
Bacterial Diversity and Number of Bacteria Present in the Wound 02-002 - Total Gram + Anaerobes/Week 4	—	3.83 Log^10 CFU/g
Bacterial Diversity and Number of Bacteria Present in the Wound Subject 02-003 - Total Gram Positive Anaerobes/Pre	8.66 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound 02-003 - Total Gram + Anaerobes/Post	3.36 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound 02-003 - Total Gram + Anaerobes/Week 4	7.60 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound Subject 02-004 - Total Gram Positive Anaerobes/Pre	—	5.02 Log^10 CFU/g
Bacterial Diversity and Number of Bacteria Present in the Wound 02-004 - Total Gram + Anaerobes/Post	—	3.80 Log^10 CFU/g
Bacterial Diversity and Number of Bacteria Present in the Wound 02-004 - Total Gram + Anaerobes/Week 4	—	6.43 Log^10 CFU/g
Bacterial Diversity and Number of Bacteria Present in the Wound Subject 02-005 - Total Gram Positive Anaerobes/Pre	—	7.42 Log^10 CFU/g
Bacterial Diversity and Number of Bacteria Present in the Wound 02-005 - Total Gram + Anaerobes/Post	—	5.58 Log^10 CFU/g
Bacterial Diversity and Number of Bacteria Present in the Wound Subject 02-007 - Total Gram Positive Anaerobes/Pre	5.28 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound 02-007 - Total Gram + Anaerobes/Post	3.29 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound 02-007 - Total Gram + Anaerobes/Week 4	3.92 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound Subject 02-008 - Total Gram Positive Anaerobes/Pre	—	7.61 Log^10 CFU/g
Bacterial Diversity and Number of Bacteria Present in the Wound 02-008 - Total Gram + Anaerobes/Post	—	7.41 Log^10 CFU/g
Bacterial Diversity and Number of Bacteria Present in the Wound 02-008 - Total Gram + Anaerobes/Week 4	—	0.00 Log^10 CFU/g
Bacterial Diversity and Number of Bacteria Present in the Wound Subject 02-009 - Total Gram Positive Anaerobes/Pre	4.28 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound 02-009 - Total Gram + Anaerobes/Post	0.00 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound 02-009 - Total Gram + Anaerobes/Week 4	8.70 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound Subject 02-010 - Total Gram Positive Anaerobes/Pre	4.30 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound 02-010 - Total Gram + Anaerobes/Post	3.15 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound 02-010 - Total Gram + Anaerobes/Week 4	7.66 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound Subject 02-001 - Total Gram Negative Anaerobes/Pre	6.98 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound 02-001 - Total Gram - Anaerobes/Post	3.21 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound 02-001 - Total Gram - Anaerobes/Week 4	4.80 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound Subject 02-002 - Total Gram Negative Anaerobes/Pre	—	7.30 Log^10 CFU/g
Bacterial Diversity and Number of Bacteria Present in the Wound 02-002 - Total Gram - Anaerobes/Post	—	5.57 Log^10 CFU/g
Bacterial Diversity and Number of Bacteria Present in the Wound 02-002 - Total Gram - Anaerobes/Week 4	—	4.75 Log^10 CFU/g
Bacterial Diversity and Number of Bacteria Present in the Wound Subject 02-003 - Total Gram Negative Anaerobes/Pre	8.90 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound 02-003 - Total Gram - Anaerobes/Post	3.70 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound 02-003 - Total Gram - Anaerobes/Week 4	0.00 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound Subject 02-004 - Total Gram Negative Anaerobes/Pre	—	0.00 Log^10 CFU/g
Bacterial Diversity and Number of Bacteria Present in the Wound 02-004 - Total Gram - Anaerobes/Post	—	0.00 Log^10 CFU/g
Bacterial Diversity and Number of Bacteria Present in the Wound 02-004 - Total Gram - Anaerobes/Week 4	—	5.88 Log^10 CFU/g
Bacterial Diversity and Number of Bacteria Present in the Wound Subject 02-005 - Total Gram Negative Anaerobes/Pre	—	6.54 Log^10 CFU/g
Bacterial Diversity and Number of Bacteria Present in the Wound 02-005 - Total Gram - Anaerobes/Post	—	5.59 Log^10 CFU/g
Bacterial Diversity and Number of Bacteria Present in the Wound 02-005 - Total Gram - Anaerobes/Week 4	—	6.30 Log^10 CFU/g
Bacterial Diversity and Number of Bacteria Present in the Wound Subject 02-007 - Total Gram Negative Anaerobes/Pre	7.54 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound 02-007 - Total Gram - Anaerobes/Post	5.13 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound 02-007 - Total Gram - Anaerobes/Week 4	7.89 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound Subject 02-008 - Total Gram Negative Anaerobes/Pre	—	3.31 Log^10 CFU/g
Bacterial Diversity and Number of Bacteria Present in the Wound 02-008 - Total Gram - Anaerobes/Post	—	0.00 Log^10 CFU/g
Bacterial Diversity and Number of Bacteria Present in the Wound 02-008 - Total Gram - Anaerobes/Week 4	—	0.00 Log^10 CFU/g
Bacterial Diversity and Number of Bacteria Present in the Wound Subject 02-009 - Total Gram Negative Anaerobes/Pre	5.82 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound 02-009 - Total Gram - Anaerobes/Post	3.96 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound 02-009 - Total Gram - Anaerobes/Week 4	3.59 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound Subject 02-010 - Total Gram Negative Anaerobes/Pre	5.73 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound 02-010 - Total Gram - Anaerobes/Post	6.07 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound 02-010 - Total Gram - Anaerobes/Week 4	8.62 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound Subject 02-001 - Total Staphylococci/Pre	7.11 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound 02-001 - Total Staph/Post	4.56 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound 02-001 - Total Staph/Week 4	0.00 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound Subject 02-002 - Total Staphylococci/Pre	—	6.39 Log^10 CFU/g
Bacterial Diversity and Number of Bacteria Present in the Wound 02-002 - Total Staph/Post	—	5.92 Log^10 CFU/g
Bacterial Diversity and Number of Bacteria Present in the Wound 02-002 - Total Staph/Week 4	—	0.00 Log^10 CFU/g
Bacterial Diversity and Number of Bacteria Present in the Wound Subject 02-003 - Total Staphylococci/Pre	8.75 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound 02-003 - Total Staph/Post	4.38 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound 02-003 - Total Staph/Week 4	6.70 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound Subject 02-004 - Total Staphylococci/Pre	—	5.15 Log^10 CFU/g
Bacterial Diversity and Number of Bacteria Present in the Wound 02-004 - Total Staph/Post	—	3.25 Log^10 CFU/g
Bacterial Diversity and Number of Bacteria Present in the Wound 02-004 - Total Staph/Week 4	—	7.55 Log^10 CFU/g
Bacterial Diversity and Number of Bacteria Present in the Wound Subject 02-005 - Total Staphylococci/Pre	—	8.37 Log^10 CFU/g
Bacterial Diversity and Number of Bacteria Present in the Wound 02-005 - Total Staph/Post	—	6.67 Log^10 CFU/g
Bacterial Diversity and Number of Bacteria Present in the Wound 02-005 - Total Staph/Week 4	—	6.69 Log^10 CFU/g
Bacterial Diversity and Number of Bacteria Present in the Wound Subject 02-007 - Total Staphylococci/Pre	0.00 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound 02-007 - Total Staph/Post	0.00 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound 02-007 - Total Staph/Week 4	3.93 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound Subject 02-008 - Total Staphylococci/Pre	—	7.24 Log^10 CFU/g
Bacterial Diversity and Number of Bacteria Present in the Wound 02-008 - Total Staph/Post	—	5.93 Log^10 CFU/g
Bacterial Diversity and Number of Bacteria Present in the Wound 02-008 - Total Staph/Week 4	—	3.43 Log^10 CFU/g
Bacterial Diversity and Number of Bacteria Present in the Wound Subject 02-009 - Total Staphylococci/Pre	6.97 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound 02-009 - Total Staph/Post	4.64 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound 02-009 - Total Staph/Week 4	8.47 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound Subject 02-010 - Total Staphylococci/Pre	7.05 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound 02-010 - Total Staph/Post	6.87 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound 02-010 - Total Staph/Week 4	8.15 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound Subject 02-001 - Total S. aureus/Pre	0.00 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound 02-001 - Total S. aureus/Post	0.00 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound 02-001 - Total S. aureus/Week 4	0.00 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound Subject 02-002 - Total S. aureus/Pre	—	0.00 Log^10 CFU/g
Bacterial Diversity and Number of Bacteria Present in the Wound 02-002 - Total S. aureus/Post	—	0.00 Log^10 CFU/g
Bacterial Diversity and Number of Bacteria Present in the Wound 02-002 - Total S. aureus/Week 4	—	0.00 Log^10 CFU/g
Bacterial Diversity and Number of Bacteria Present in the Wound Subject 02-003 - Total S. aureus/Pre	0.00 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound 02-003 - Total S. aureus/Post	0.00 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound 02-003 - Total S. aureus/Week 4	6.58 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound Subject 02-004 - Total S. aureus/Pre	—	0.00 Log^10 CFU/g
Bacterial Diversity and Number of Bacteria Present in the Wound 02-004 - Total S. aureus/Post	—	0.00 Log^10 CFU/g
Bacterial Diversity and Number of Bacteria Present in the Wound 02-004 - Total S. aureus/Week 4	—	0.00 Log^10 CFU/g
Bacterial Diversity and Number of Bacteria Present in the Wound Subject 02-005 - Total S. aureus/Pre	—	0.00 Log^10 CFU/g
Bacterial Diversity and Number of Bacteria Present in the Wound 02-005 - Total S. aureus/Post	—	0.00 Log^10 CFU/g
Bacterial Diversity and Number of Bacteria Present in the Wound 02-005 - Total S. aureus/Week 4	—	0.00 Log^10 CFU/g
Bacterial Diversity and Number of Bacteria Present in the Wound Subject 02-007 - Total S. aureus/Pre	0.00 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound 02-007 - Total S. aureus/Post	0.00 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound 02-007 - Total S. aureus/Week 4	0.00 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound Subject 02-008 - Total S. aureus/Pre	—	6.89 Log^10 CFU/g
Bacterial Diversity and Number of Bacteria Present in the Wound 02-008 - Total S. aureus/Post	—	5.49 Log^10 CFU/g
Bacterial Diversity and Number of Bacteria Present in the Wound 02-008 - Total S. aureus/Week 4	—	0.00 Log^10 CFU/g
Bacterial Diversity and Number of Bacteria Present in the Wound Subject 02-009 - Total S. aureus/Pre	0.00 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound 02-009 - Total S. aureus/Post	0.00 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound 02-009 - Total S. aureus/Week 4	0.00 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound Subject 02-010 - Total S. aureus/Pre	0.00 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound 02-010 - Total S. aureus/Post	0.00 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound 02-010 - Total S. aureus/Week 4	0.00 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound Subject 02-001 - Total Coliforms/Pre	6.83 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound 02-001 - Total Coliforms/Post	3.53 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound 02-001 - Total Coliforms/Week 4	0.00 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound Subject 02-002 - Total Coliforms/Pre	—	6.84 Log^10 CFU/g
Bacterial Diversity and Number of Bacteria Present in the Wound 02-002 - Total Coliforms/Post	—	5.58 Log^10 CFU/g
Bacterial Diversity and Number of Bacteria Present in the Wound 02-002 - Total Coliforms/Week 4	—	4.68 Log^10 CFU/g
Bacterial Diversity and Number of Bacteria Present in the Wound Subject 02-003 - Total Coliforms/Pre	0.00 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound 02-003 - Total Coliforms/Post	0.00 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound 02-003 - Total Coliforms/Week 4	0.00 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound Subject 02-004 - Total Coliforms/Pre	—	0.00 Log^10 CFU/g
Bacterial Diversity and Number of Bacteria Present in the Wound 02-004 - Total Coliforms/Post	—	0.00 Log^10 CFU/g
Bacterial Diversity and Number of Bacteria Present in the Wound 02-004 - Total Coliforms/Week 4	—	4.23 Log^10 CFU/g
Bacterial Diversity and Number of Bacteria Present in the Wound Subject 02-005 - Total Coliforms/Pre	—	6.50 Log^10 CFU/g
Bacterial Diversity and Number of Bacteria Present in the Wound 02-005 - Total Coliforms/Post	—	5.56 Log^10 CFU/g
Bacterial Diversity and Number of Bacteria Present in the Wound 02-005 - Total Coliforms/Week 4	—	6.26 Log^10 CFU/g
Bacterial Diversity and Number of Bacteria Present in the Wound Subject 02-007 - Total Coliforms/Pre	7.33 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound 02-007 - Total Coliforms/Post	4.99 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound 02-007 - Total Coliforms/Week 4	4.57 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound Subject 02-008 - Total Coliforms/Pre	—	7.75 Log^10 CFU/g
Bacterial Diversity and Number of Bacteria Present in the Wound 02-008 - Total Coliforms/Post	—	7.37 Log^10 CFU/g
Bacterial Diversity and Number of Bacteria Present in the Wound 02-008 - Total Coliforms/Week 4	—	0.00 Log^10 CFU/g
Bacterial Diversity and Number of Bacteria Present in the Wound Subject 02-009 - Total Coliforms/Pre	0.00 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound 02-009 - Total Coliforms/Post	0.00 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound 02-009 - Total Coliforms/Week 4	0.00 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound Subject 02-010 - Total Coliforms/Pre	7.14 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound 02-010 - Total Coliforms/Post	6.89 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound 02-010 - Total Coliforms/Week 4	8.24 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound Subject 02-001 - Total Pseudomonads/Pre	0.00 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound 02-001 - Total Pseudomonads/Post	0.00 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound 02-001 - Total Pseudomonads/Week 4	0.00 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound Subject 02-002 - Total Pseudomonads/Pre	—	0.00 Log^10 CFU/g
Bacterial Diversity and Number of Bacteria Present in the Wound 02-002 - Total Pseudomonads/Post	—	0.00 Log^10 CFU/g
Bacterial Diversity and Number of Bacteria Present in the Wound 02-002 - Total Pseudomonads/Week 4	—	0.00 Log^10 CFU/g
Bacterial Diversity and Number of Bacteria Present in the Wound Subject 02-003 - Total Pseudomonads/Pre	0.00 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound 02-003 - Total Pseudomonads/Post	0.00 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound 02-003 - Total Pseudomonads/Week 4	0.00 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound Subject 02-004 - Total Pseudomonads/Pre	—	5.89 Log^10 CFU/g
Bacterial Diversity and Number of Bacteria Present in the Wound 02-004 - Total Pseudomonads/Post	—	4.87 Log^10 CFU/g
Bacterial Diversity and Number of Bacteria Present in the Wound 02-004 - Total Pseudomonads/Week 4	—	4.43 Log^10 CFU/g
Bacterial Diversity and Number of Bacteria Present in the Wound Subject 02-005 - Total Pseudomonads/Pre	—	0.00 Log^10 CFU/g
Bacterial Diversity and Number of Bacteria Present in the Wound 02-005 - Total Pseudomonads/Post	—	0.00 Log^10 CFU/g
Bacterial Diversity and Number of Bacteria Present in the Wound 02-005 - Total Pseudomonads/Week 4	—	0.00 Log^10 CFU/g
Bacterial Diversity and Number of Bacteria Present in the Wound Subject 02-007 - Total Pseudomonads/Pre	0.00 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound 02-007 - Total Pseudomonads/Post	0.00 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound 02-007 - Total Pseudomonads/Week 4	0.00 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound Subject 02-008 - Total Pseudomonads/Pre	—	0.00 Log^10 CFU/g
Bacterial Diversity and Number of Bacteria Present in the Wound 02-008 - Total Pseudomonads/Post	—	0.00 Log^10 CFU/g
Bacterial Diversity and Number of Bacteria Present in the Wound 02-008 - Total Pseudomonads/Week 4	—	0.00 Log^10 CFU/g
Bacterial Diversity and Number of Bacteria Present in the Wound Subject 02-009 - Total Pseudomonads/Pre	0.00 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound 02-009 - Total Pseudomonads/Post	0.00 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound 02-009 - Total Pseudomonads/Week 4	0.00 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound Subject 02-010 - Total Pseudomonads/Pre	0.00 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound 02-010 - Total Pseudomonads/Post	0.00 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound 02-010 - Total Pseudomonads/Week 4	0.00 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound Subject 02-001 - Total Strep/Pre	0.00 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound 02-001 - Total Strep/Post	0.00 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound 02-001 - Total Strep/Week 4	0.00 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound Subject 02-002 - Total Strep/Pre	—	0.00 Log^10 CFU/g
Bacterial Diversity and Number of Bacteria Present in the Wound 02-002 - Total Strep/Post	—	0.00 Log^10 CFU/g
Bacterial Diversity and Number of Bacteria Present in the Wound 02-002 - Total Strep/Week 4	—	0.00 Log^10 CFU/g
Bacterial Diversity and Number of Bacteria Present in the Wound Subject 02-003 - Total Strep/Pre	0.00 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound 02-003 - Total Strep/Post	0.00 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound 02-003 - Total Strep/Week 4	0.00 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound Subject 02-004 - Total Strep/Pre	—	0.00 Log^10 CFU/g
Bacterial Diversity and Number of Bacteria Present in the Wound 02-004 - Total Strep/Post	—	0.00 Log^10 CFU/g
Bacterial Diversity and Number of Bacteria Present in the Wound 02-004 - Total Strep/Week 4	—	0.00 Log^10 CFU/g
Bacterial Diversity and Number of Bacteria Present in the Wound Subject 02-005 - Total Strep/Pre	—	0.00 Log^10 CFU/g
Bacterial Diversity and Number of Bacteria Present in the Wound 02-005 - Total Strep/Post	—	0.00 Log^10 CFU/g
Bacterial Diversity and Number of Bacteria Present in the Wound 02-005 - Total Strep/Week 4	—	0.00 Log^10 CFU/g
Bacterial Diversity and Number of Bacteria Present in the Wound Subject 02-007 - Total Strep/Pre	0.00 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound 02-007 - Total Strep/Post	0.00 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound 02-007 - Total Strep/Week 4	0.00 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound Subject 02-008 - Total Strep/Pre	—	0.00 Log^10 CFU/g
Bacterial Diversity and Number of Bacteria Present in the Wound 02-008 - Total Strep/Post	—	0.00 Log^10 CFU/g
Bacterial Diversity and Number of Bacteria Present in the Wound 02-008 - Total Strep/Week 4	—	0.00 Log^10 CFU/g
Bacterial Diversity and Number of Bacteria Present in the Wound Subject 02-009 - Total Strep/Pre	0.00 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound 02-009 - Total Strep/Post	0.00 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound 02-009 - Total Strep/Week 4	0.00 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound Subject 02-010 - Total Strep/Pre	0.00 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound 02-010 - Total Strep/Post	0.00 Log^10 CFU/g	—
Bacterial Diversity and Number of Bacteria Present in the Wound 02-010 - Total Strep/Week 4	0.00 Log^10 CFU/g	—

SECONDARY outcome

Timeframe: Visit 2 through Visit 8 (12 weeks)

Population: All treated subjects

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.

Outcome measures

Outcome measures
Measure	WoundWand™ Debridement Device n=5 Participants 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 n=4 Participants 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.
Photograph Area Measurements to Determine Reduction in Wound Size 02-009 Visit 5/Week 3	23.02 cm^2	—
Photograph Area Measurements to Determine Reduction in Wound Size 02-009 Visit 6/Week 4	38.27 cm^2	—
Photograph Area Measurements to Determine Reduction in Wound Size 02-004 Visit 7/Week 6	—	0.42 cm^2
Photograph Area Measurements to Determine Reduction in Wound Size 02-004 Visit 8/Week 12	—	0.33 cm^2
Photograph Area Measurements to Determine Reduction in Wound Size Subject 02-005 Visit 2/Pre Debridement	—	16.20 cm^2
Photograph Area Measurements to Determine Reduction in Wound Size 02-005 Visit 2/Post Debridement	—	28.74 cm^2
Photograph Area Measurements to Determine Reduction in Wound Size 02-005 Visit 3/Week 1	—	19.53 cm^2
Photograph Area Measurements to Determine Reduction in Wound Size 02-005 Visit 3/Week 1 measurement 2	—	19.98 cm^2
Photograph Area Measurements to Determine Reduction in Wound Size 02-005 Visit 4/Week 2	—	23.67 cm^2
Photograph Area Measurements to Determine Reduction in Wound Size 02-005 Visit 5/Week 3	—	22.16 cm^2
Photograph Area Measurements to Determine Reduction in Wound Size 02-005 Visit 6/Week 4	—	21.40 cm^2
Photograph Area Measurements to Determine Reduction in Wound Size 02-005 Visit 7/Week 6	—	34.06 cm^2
Photograph Area Measurements to Determine Reduction in Wound Size 02-005 Visit 8/Week 12	—	26.56 cm^2
Photograph Area Measurements to Determine Reduction in Wound Size Subject 02-007 Visit 2/Pre Debridement	23.56 cm^2	—
Photograph Area Measurements to Determine Reduction in Wound Size 02-007 Visit 2/Pre Debridement	25.87 cm^2	—
Photograph Area Measurements to Determine Reduction in Wound Size 02-007 Visit 2/Post Debridement	NA cm^2 Area measurement not reported by study site to Sponsor.	—
Photograph Area Measurements to Determine Reduction in Wound Size 02-007 Visit 3/Week 1	26.91 cm^2	—
Photograph Area Measurements to Determine Reduction in Wound Size 02-007 Visit 4/Week 2	23.02 cm^2	—
Photograph Area Measurements to Determine Reduction in Wound Size 02-007 Visit 5/Week 3	24.89 cm^2	—
Photograph Area Measurements to Determine Reduction in Wound Size 02-007 Visit 6/Week 4	28.04 cm^2	—
Photograph Area Measurements to Determine Reduction in Wound Size 02-007 Visit 7/Week 6	NA cm^2 Subject did not attend Visit 7.	—
Photograph Area Measurements to Determine Reduction in Wound Size 02-007 Visit 8/Week 12	NA cm^2 Subject did not attend Visit 8.	—
Photograph Area Measurements to Determine Reduction in Wound Size Subject 02-008 Visit 2/Pre Debridement	—	29.53 cm^2
Photograph Area Measurements to Determine Reduction in Wound Size 02-008 Visit 2/Post Debridement	—	86.16 cm^2
Photograph Area Measurements to Determine Reduction in Wound Size 02-008 Visit 3/Week 1	—	50.26 cm^2
Photograph Area Measurements to Determine Reduction in Wound Size 02-008 Visit 3/Week 1 measurement 2	—	85.47 cm^2
Photograph Area Measurements to Determine Reduction in Wound Size 02-008 Visit 4/Week 2	—	30.13 cm^2
Photograph Area Measurements to Determine Reduction in Wound Size 02-008 Visit 4/Week 2 measurement 2	—	72.20 cm^2
Photograph Area Measurements to Determine Reduction in Wound Size 02-008 Visit 5/Week 3	—	19.65 cm^2
Photograph Area Measurements to Determine Reduction in Wound Size 02-008 Visit 5/Week 3 measurement 2	—	33.32 cm^2
Photograph Area Measurements to Determine Reduction in Wound Size 02-008 Visit 6/Week 4	—	93.46 cm^2
Photograph Area Measurements to Determine Reduction in Wound Size 02-008 Visit 6/Week 4 measurement 2	—	24.75 cm^2
Photograph Area Measurements to Determine Reduction in Wound Size 02-008 Visit 7/Week 6	—	NA cm^2 Subject did not attend Visit 7.
Photograph Area Measurements to Determine Reduction in Wound Size 02-008 Visit 8/Week 12	—	NA cm^2 Subject did not attend Visit 8.
Photograph Area Measurements to Determine Reduction in Wound Size Subject 02-009 Visit 2/Pre Debridement	50.49 cm^2	—
Photograph Area Measurements to Determine Reduction in Wound Size 02-009 Visit 2/Post Debridement	35.05 cm^2	—
Photograph Area Measurements to Determine Reduction in Wound Size 02-009 Visit 3/Week 1	67.80 cm^2	—
Photograph Area Measurements to Determine Reduction in Wound Size 02-009 Visit 4/Week 2	26.84 cm^2	—
Photograph Area Measurements to Determine Reduction in Wound Size 02-009 Visit 7/Week 6	NA cm^2 Subject did not attend Visit 7.	—
Photograph Area Measurements to Determine Reduction in Wound Size 02-009 Visit 8/Week 12	NA cm^2 Subject did not attend Visit 8.	—
Photograph Area Measurements to Determine Reduction in Wound Size Subject 02-010 Visit 2/Pre Debridement	9.03 cm^2	—
Photograph Area Measurements to Determine Reduction in Wound Size 02-010 Visit 2/Post Debridement	9.39 cm^2	—
Photograph Area Measurements to Determine Reduction in Wound Size 02-010 Visit 3/Week 1	24.15 cm^2	—
Photograph Area Measurements to Determine Reduction in Wound Size 02-010 Visit 3/Week 1 measurement 2	6.55 cm^2	—
Photograph Area Measurements to Determine Reduction in Wound Size 02-010 Visit 4/Week 2	6.99 cm^2	—
Photograph Area Measurements to Determine Reduction in Wound Size 02-010 Visit 5/Week 3	5.08 cm^2	—
Photograph Area Measurements to Determine Reduction in Wound Size 02-010 Visit 6/Week 4	15.42 cm^2	—
Photograph Area Measurements to Determine Reduction in Wound Size 02-010 Visit 7/Week 6	NA cm^2 Area measurement not reported by study site to Sponsor.	—
Photograph Area Measurements to Determine Reduction in Wound Size 02-010 Visit 8/Week 12	NA cm^2 Area measurement not reported by study site to Sponsor.	—
Photograph Area Measurements to Determine Reduction in Wound Size Subject 02-001 Visit 2/Pre Debridement	NA cm^2 Area measurement not reported by study site to Sponsor.	—
Photograph Area Measurements to Determine Reduction in Wound Size 02-001 Visit 2/Post Debridement	80.24 cm^2	—
Photograph Area Measurements to Determine Reduction in Wound Size 02-001 Visit 3/Week 1	57.24 cm^2	—
Photograph Area Measurements to Determine Reduction in Wound Size 02-001 Visit 4/Week 2	58.36 cm^2	—
Photograph Area Measurements to Determine Reduction in Wound Size 02-001 Visit 5/Week 3	50.15 cm^2	—
Photograph Area Measurements to Determine Reduction in Wound Size 02-001 Visit 6/Week 4	52.12 cm^2	—
Photograph Area Measurements to Determine Reduction in Wound Size 02-001 Visit 7/Week 6	35.61 cm^2	—
Photograph Area Measurements to Determine Reduction in Wound Size 02-001 Visit 7/Week 6 measurement 2	29.70 cm^2	—
Photograph Area Measurements to Determine Reduction in Wound Size 02-001 Visit 8/Week 12	17.84 cm^2	—
Photograph Area Measurements to Determine Reduction in Wound Size Subject 02-002 Visit 2/Pre Debridement	—	41.80 cm^2
Photograph Area Measurements to Determine Reduction in Wound Size 02-002 Visit 2/Post Debridement	—	NA cm^2 Area measurement not reported by study site to Sponsor.
Photograph Area Measurements to Determine Reduction in Wound Size 02-002 Visit 3/Week 1	—	53.59 cm^2
Photograph Area Measurements to Determine Reduction in Wound Size 02-002 Visit 4/Week 2	—	30.03 cm^2
Photograph Area Measurements to Determine Reduction in Wound Size 02-002 Visit 5/Week 3	—	40.08 cm^2
Photograph Area Measurements to Determine Reduction in Wound Size 02-002 Visit 6/Week 4	—	31.73 cm^2
Photograph Area Measurements to Determine Reduction in Wound Size 02-002 Visit 7/Week 6	—	37.43 cm^2
Photograph Area Measurements to Determine Reduction in Wound Size 02-002 Visit 7/Week 6 measurement 2	—	33.99 cm^2
Photograph Area Measurements to Determine Reduction in Wound Size 02-002 Visit 8/Week 12	—	22.79 cm^2
Photograph Area Measurements to Determine Reduction in Wound Size Subject 02-003 Visit 2/Pre Debridement	6.80 cm^2	—
Photograph Area Measurements to Determine Reduction in Wound Size 02-003 Visit 2/Post Debridement	9.34 cm^2	—
Photograph Area Measurements to Determine Reduction in Wound Size 02-003 Visit 3/Week 1	6.25 cm^2	—
Photograph Area Measurements to Determine Reduction in Wound Size 02-003 Visit 4/Week 2	6.29 cm^2	—
Photograph Area Measurements to Determine Reduction in Wound Size 02-003 Visit 4/Week 2 measurement 2	9.18 cm^2	—
Photograph Area Measurements to Determine Reduction in Wound Size 02-003 Visit 5/Week 3	2.88 cm^2	—
Photograph Area Measurements to Determine Reduction in Wound Size 02-003 Visit 6/Week 4	3.05 cm^2	—
Photograph Area Measurements to Determine Reduction in Wound Size 02-003 Visit 7/Week 6	3.99 cm^2	—
Photograph Area Measurements to Determine Reduction in Wound Size 02-003 Visit 8/Week 12	1.43 cm^2	—
Photograph Area Measurements to Determine Reduction in Wound Size Subject 02-004 Visit 2/Pre Debridement	—	2.37 cm^2
Photograph Area Measurements to Determine Reduction in Wound Size 02-004 Visit 2/Post Debridement	—	0.59 cm^2
Photograph Area Measurements to Determine Reduction in Wound Size 02-004 Visit 3/Week 1	—	1.25 cm^2
Photograph Area Measurements to Determine Reduction in Wound Size 02-004 Visit 3/Week 1 measurement 2	—	1.35 cm^2
Photograph Area Measurements to Determine Reduction in Wound Size 02-004 Visit 4/Week 2	—	1.02 cm^2
Photograph Area Measurements to Determine Reduction in Wound Size 02-004 Visit 5/Week 3	—	1.84 cm^2
Photograph Area Measurements to Determine Reduction in Wound Size 02-004 Visit 6/Week 4	—	2.41 cm^2

SECONDARY outcome

Timeframe: Screening through Visit 8 (12 weeks)

Population: All subjects seen and assessed at each time point.

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.

Outcome measures

Outcome measures
Measure	WoundWand™ Debridement Device n=5 Participants 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 n=4 Participants 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.
Wound Status Using Bates-Jensen Wound Assessment - Total Score Visit 1/Screening	33.2 total score on a scale Standard Deviation 3.1	33.8 total score on a scale Standard Deviation 4.8
Wound Status Using Bates-Jensen Wound Assessment - Total Score Visit 2/Debridement	35.2 total score on a scale Standard Deviation 5.8	33.3 total score on a scale Standard Deviation 5.6
Wound Status Using Bates-Jensen Wound Assessment - Total Score Visit 3/Week 1	31.0 total score on a scale Standard Deviation 6.4	34.0 total score on a scale Standard Deviation 5.0
Wound Status Using Bates-Jensen Wound Assessment - Total Score Visit 4/Week 2	27.8 total score on a scale Standard Deviation 2.9	33.3 total score on a scale Standard Deviation 5.4
Wound Status Using Bates-Jensen Wound Assessment - Total Score Visit 5/Week 3	25.2 total score on a scale Standard Deviation 3.1	33.3 total score on a scale Standard Deviation 6.1
Wound Status Using Bates-Jensen Wound Assessment - Total Score Visit 6/Week 4	25.5 total score on a scale Standard Deviation 5.7	32.3 total score on a scale Standard Deviation 7.6
Wound Status Using Bates-Jensen Wound Assessment - Total Score Visit 7/Week 6	18.7 total score on a scale Standard Deviation 0.6	31.0 total score on a scale Standard Deviation 10.1
Wound Status Using Bates-Jensen Wound Assessment - Total Score Visit 8/Week 12	16.0 total score on a scale Standard Deviation 1.7	31.0 total score on a scale Standard Deviation 20.9

SECONDARY outcome

Timeframe: Screening through Visit 8 (12 weeks)

Population: All available subjects at each time point.

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.

Outcome measures

Outcome measures
Measure	WoundWand™ Debridement Device n=5 Participants 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 n=4 Participants 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.
Braden Scale for Predicting Pressure Sore Risk - Total Score Visit 1/Screening	17.8 total score on a scale Standard Deviation 2.6	18.5 total score on a scale Standard Deviation 3.1
Braden Scale for Predicting Pressure Sore Risk - Total Score Visit 3/Week 1	17.6 total score on a scale Standard Deviation 2.9	18.0 total score on a scale Standard Deviation 2.2
Braden Scale for Predicting Pressure Sore Risk - Total Score Visit 4/Week 2	17.8 total score on a scale Standard Deviation 3.1	18.0 total score on a scale Standard Deviation 2.2
Braden Scale for Predicting Pressure Sore Risk - Total Score Visit 5/Week 3	17.8 total score on a scale Standard Deviation 3.6	18.3 total score on a scale Standard Deviation 2.9
Braden Scale for Predicting Pressure Sore Risk - Total Score Visit 6/Week 4	17.8 total score on a scale Standard Deviation 2.8	18.5 total score on a scale Standard Deviation 3.3
Braden Scale for Predicting Pressure Sore Risk - Total Score Visit 7/Week 6	18.0 total score on a scale Standard Deviation 1.7	20.0 total score on a scale Standard Deviation 4.4
Braden Scale for Predicting Pressure Sore Risk - Total Score Visit 8/Week 12	19.3 total score on a scale Standard Deviation 3.8	20.0 total score on a scale Standard Deviation 4.4

Adverse Events

WoundWand™ Debridement Device

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Standard of Care Sharp Debridement

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	WoundWand™ Debridement Device n=5 participants at risk 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	Standard of Care Sharp Debridement n=4 participants at risk 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
Cardiac disorders 2:1 AV block and bradycardia	20.0% 1/5 • Number of events 1 • AEs were collected from the time of enrollment until study completion at 12 weeks post debridement, study withdrawal, or study termination, whichever came first.	0.00% 0/4 • AEs were collected from the time of enrollment until study completion at 12 weeks post debridement, study withdrawal, or study termination, whichever came first.
Infections and infestations Micro groin wound infection	20.0% 1/5 • Number of events 1 • AEs were collected from the time of enrollment until study completion at 12 weeks post debridement, study withdrawal, or study termination, whichever came first.	0.00% 0/4 • AEs were collected from the time of enrollment until study completion at 12 weeks post debridement, study withdrawal, or study termination, whichever came first.
Infections and infestations Infection to wound	0.00% 0/5 • AEs were collected from the time of enrollment until study completion at 12 weeks post debridement, study withdrawal, or study termination, whichever came first.	25.0% 1/4 • Number of events 1 • AEs were collected from the time of enrollment until study completion at 12 weeks post debridement, study withdrawal, or study termination, whichever came first.
Infections and infestations Chronic wound	40.0% 2/5 • Number of events 2 • AEs were collected from the time of enrollment until study completion at 12 weeks post debridement, study withdrawal, or study termination, whichever came first.	25.0% 1/4 • Number of events 1 • AEs were collected from the time of enrollment until study completion at 12 weeks post debridement, study withdrawal, or study termination, whichever came first.
Infections and infestations Infection to foot ulcer	20.0% 1/5 • Number of events 1 • AEs were collected from the time of enrollment until study completion at 12 weeks post debridement, study withdrawal, or study termination, whichever came first.	0.00% 0/4 • AEs were collected from the time of enrollment until study completion at 12 weeks post debridement, study withdrawal, or study termination, whichever came first.
Infections and infestations Serratia growth on bone	20.0% 1/5 • Number of events 1 • AEs were collected from the time of enrollment until study completion at 12 weeks post debridement, study withdrawal, or study termination, whichever came first.	0.00% 0/4 • AEs were collected from the time of enrollment until study completion at 12 weeks post debridement, study withdrawal, or study termination, whichever came first.

Additional Information

Henry Jaimes

Smith & Nephew

Phone: 01923-477-164

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	WoundWand™ Debridement Device n=5 Participants 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 n=4 Participants 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 n=9 Participants Total of all reporting groups
Age, Continuous	66.4 years STANDARD_DEVIATION 8.6 • n=5 Participants	68.8 years STANDARD_DEVIATION 13.6 • n=7 Participants	67.8 years STANDARD_DEVIATION 10.4 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United Kingdom	5 participants n=5 Participants	4 participants n=7 Participants	9 participants n=5 Participants
Etiology of Study Wound Pressure	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Etiology of Study Wound Pressure and Neuropathy	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Etiology of Study Wound Infection	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Etiology of Study Wound Infection, Trauma and Neuropathy	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Etiology of Study Wound Laceration	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Etiology of Study Wound Abrasion	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Etiology of Study Wound Trauma	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Etiology of Study Wound Surgical Procedure	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Etiology of Study Wound Surgical Procedure and Underlying Condition	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Etiology of Study Wound Vascular Insufficiency	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Etiology of Study Wound Neuropathy	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Etiology of Study Wound Underlying Condition	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Etiology of Study Wound Other	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Type of Wound Chronic	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Type of Wound Chronic and Diabetic Foot Ulcer	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Type of Wound Acute	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Type of Wound Diabetic Foot Ulcer	5 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants
Type of Wound Venous Leg Ulcer	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants