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

Not Applicable

Terminated

Conditions: Lower Leg Wound

Interventions: Device: Standard of Care sharp debridement
Device: WoundWand™ Debridement Device

Registration Number: NCT01924806

Lead Sponsor: Smith & Nephew, Inc.

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

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 11

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of Care sharp debridement	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.
WoundWand™ Debridement Device	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.