18 and older, any sex, with Lower Leg Wound. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Bacterial Diversity and Number of Bacteria Present in the WoundPrimary· 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
Subject 02-001 - Total Aerobes/Pre
Group
Value
95% CI
WoundWand™ Debridement Device
7.74
02-001 - Total Aerobes/Post
Group
Value
95% CI
WoundWand™ Debridement Device
7.25
02-001 - Total Aerobes/Week 4
Group
Value
95% CI
WoundWand™ Debridement Device
6.29
Subject 02-002 - Total Aerobes/Pre
Group
Value
95% CI
Standard of Care Sharp Debridement
8.37
02-002 - Total Aerobes/Post
Group
Value
95% CI
Standard of Care Sharp Debridement
7.05
02-002 - Total Aerobes/Week 4
Group
Value
95% CI
Standard of Care Sharp Debridement
5.31
Subject 02-003 - Total Aerobes/Pre
Group
Value
95% CI
WoundWand™ Debridement Device
9.14
02-003 - Total Aerobes/Post
Group
Value
95% CI
WoundWand™ Debridement Device
4.38
Photograph Area Measurements to Determine Reduction in Wound SizeSecondary· 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.
Subject 02-001 Visit 2/Pre Debridement
Group
Value
95% CI
WoundWand™ Debridement Device
NA
02-001 Visit 2/Post Debridement
Group
Value
95% CI
WoundWand™ Debridement Device
80.24
02-001 Visit 3/Week 1
Group
Value
95% CI
WoundWand™ Debridement Device
57.24
02-001 Visit 4/Week 2
Group
Value
95% CI
WoundWand™ Debridement Device
58.36
02-001 Visit 5/Week 3
Group
Value
95% CI
WoundWand™ Debridement Device
50.15
02-001 Visit 6/Week 4
Group
Value
95% CI
WoundWand™ Debridement Device
52.12
02-001 Visit 7/Week 6
Group
Value
95% CI
WoundWand™ Debridement Device
35.61
02-001 Visit 7/Week 6 measurement 2
Group
Value
95% CI
WoundWand™ Debridement Device
29.70
Wound Status Using Bates-Jensen Wound Assessment - Total ScoreSecondary· 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 wor
Visit 1/Screening
Group
Value
95% CI
WoundWand™ Debridement Device
33.2
± 3.1
Standard of Care Sharp Debridement
33.8
± 4.8
Visit 2/Debridement
Group
Value
95% CI
WoundWand™ Debridement Device
35.2
± 5.8
Standard of Care Sharp Debridement
33.3
± 5.6
Visit 3/Week 1
Group
Value
95% CI
WoundWand™ Debridement Device
31.0
± 6.4
Standard of Care Sharp Debridement
34.0
± 5.0
Visit 4/Week 2
Group
Value
95% CI
WoundWand™ Debridement Device
27.8
± 2.9
Standard of Care Sharp Debridement
33.3
± 5.4
Visit 5/Week 3
Group
Value
95% CI
WoundWand™ Debridement Device
25.2
± 3.1
Standard of Care Sharp Debridement
33.3
± 6.1
Visit 6/Week 4
Group
Value
95% CI
WoundWand™ Debridement Device
25.5
± 5.7
Standard of Care Sharp Debridement
32.3
± 7.6
Visit 7/Week 6
Group
Value
95% CI
WoundWand™ Debridement Device
18.7
± 0.6
Standard of Care Sharp Debridement
31.0
± 10.1
Visit 8/Week 12
Group
Value
95% CI
WoundWand™ Debridement Device
16.0
± 1.7
Standard of Care Sharp Debridement
31.0
± 20.9
Braden Scale for Predicting Pressure Sore Risk - Total ScoreSecondary· 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
Visit 1/Screening
Group
Value
95% CI
WoundWand™ Debridement Device
17.8
± 2.6
Standard of Care Sharp Debridement
18.5
± 3.1
Visit 3/Week 1
Group
Value
95% CI
WoundWand™ Debridement Device
17.6
± 2.9
Standard of Care Sharp Debridement
18.0
± 2.2
Visit 4/Week 2
Group
Value
95% CI
WoundWand™ Debridement Device
17.8
± 3.1
Standard of Care Sharp Debridement
18.0
± 2.2
Visit 5/Week 3
Group
Value
95% CI
WoundWand™ Debridement Device
17.8
± 3.6
Standard of Care Sharp Debridement
18.3
± 2.9
Visit 6/Week 4
Group
Value
95% CI
WoundWand™ Debridement Device
17.8
± 2.8
Standard of Care Sharp Debridement
18.5
± 3.3
Visit 7/Week 6
Group
Value
95% CI
WoundWand™ Debridement Device
18.0
± 1.7
Standard of Care Sharp Debridement
20.0
± 4.4
Visit 8/Week 12
Group
Value
95% CI
WoundWand™ Debridement Device
19.3
± 3.8
Standard of Care Sharp Debridement
20.0
± 4.4
Adverse events — posted to ClinicalTrials.gov
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..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Smith & Nephew, Inc.
Last refreshed: 28 February 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01924806.