Lower Leg WoundWoundWandNCT01924806

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

A study testing WoundWand™ Debridement Device in people with Lower Leg Wound, run by Smith & Nephew, Inc. at 2 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

A Pilot Study of the WoundWand™ Debridement Device on Infection Prevention Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Lower Leg Wound
What is being tested?: WoundWand™ Debridement Device
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 11 participants
Where: 2 sitesin 2 countries
Study dates: 4 Mar 2014to 9 Feb 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Show all 13Show fewer

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]

Who cannot join

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

Show all 26Show fewer

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

Trial locations and contacts

2 sites in 2 countries.

Country

City, postcode or hospital

2 sites in 2 countries

France1 site

Hopital Lapeyronie
Montpellier

Other trials in France

United Kingdom1 site

Manchester Diabetes Centre
Manchester, M13 0JE

Other trials in United Kingdom

About this study

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

Read the 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.

Conditions: Lower Leg Wound
Being tested: WoundWand™ Debridement Device, Standard of Care sharp debridement
Keywords: debridement, post-debridement, infection, prevention, wound, wound tissue, wound management, WoundWand, wound size reduction, wound bed debridement, WoundWand Debridement Device, chronic wound, delayed healing, cellular senescence, acute wound, diabetic foot ulcer, venous leg ulcers, radiofrequency debridement, necrotic tissue, wound healing
Medical subject headings: Infections, Wounds and Injuries, Diabetic Foot

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

WoundWand™ Debridement DeviceDevice
Group I - Electrical energy that removes necrotic, ischemic, and/or infected tissue within a wound
Standard of Care sharp debridementDevice
Group II - Sharp instruments that remove necrotic, ischemic, and/or infected tissue within a wound

Study groups in NCT01924806
Study group	Role	What they receive
WoundWand™ Debridement Device	Active comparator	Group I - Coblator IQTM Controller plus WoundWandTM Debridement Device. Electrical energy that removes necrotic, ischemic, and/or infected tissue within a wound. Receives: Device: WoundWand™ Debridement Device
Standard of Care sharp debridement	Active comparator	Group II - Standard of Care (SoC) surgical (sharp) debridement. Sharp instruments that remove necrotic, ischemic, and/or infected tissue within a wound. Receives: Device: Standard of Care sharp debridement

What is being measured

The primary outcome is the main question the study is designed to answer.

Bacterial Diversity and Number of Bacteria Present in the Wound
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
Measured: Day 1 (immediately pre- and post-debridement) and 4 weeks post-debridement

Secondary outcomes (3)

Photograph Area Measurements to Determine Reduction in Wound Size
1. 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.
Measured: Visit 2 through Visit 8 (12 weeks)
Wound Status Using Bates-Jensen Wound Assessment - Total Score
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.
Measured: Screening through Visit 8 (12 weeks)
Braden Scale for Predicting Pressure Sore Risk - Total Score
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.
Measured: Screening through Visit 8 (12 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Mar 20149 Feb 2015

First posted19 Aug 2013 (estimated)
Study start4 Mar 2014
Primary completion9 Feb 2015
Study completion9 Feb 2015

Why it stopped: Lower than expected accrual rate and desire to reassess overall study strategy.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Lower Leg WoundStudies of the same condition, open and under way.
More trials run by Smith & Nephew, Inc.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 11 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01924806
Sponsor's protocol ID: WW-2013-02
Acronym: WoundWand
Status last verified: Feb 2020
First submitted: 13 Aug 2013
Last updated: 28 Feb 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Lower Leg Wound trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Pilot Study of the WoundWand™ Debridement Device on Infection Prevention
ClinicalTrials.gov ID: NCT01924806
Acronym / sponsor ID: WoundWand / WW-2013-02
Conditions: Lower Leg Wound
Keywords: debridement, post-debridement, infection, prevention, wound, wound tissue, wound management, WoundWand
Study type: Interventional
Recruitment status: TerminatedReason stopped: Lower than expected accrual rate and desire to reassess overall study strategy.
Enrolment: 11 participants (actual)
Lead sponsor: Smith & Nephew, Inc.Industry (pharma, biotech, devices)
Study start: 4 Mar 2014 (actual)
Primary completion: 9 Feb 2015 (actual)
Study completion: 9 Feb 2015 (actual)
First posted: 19 Aug 2013 (estimated)
Results: Posted 28 Feb 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
WoundWand™ Debridement Device	Active comparator	Device: WoundWand™ Debridement DeviceGroup I - Coblator IQTM Controller plus WoundWandTM Debridement Device. Electrical energy that removes necrotic, ischemic, and/or infected tissue within a wound.
Standard of Care sharp debridement	Active comparator	Device: Standard of Care sharp debridementGroup II - Standard of Care (SoC) surgical (sharp) debridement. Sharp instruments that remove necrotic, ischemic, and/or infected tissue within a wound.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

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:
Subjects with the following lab results within 30 days of treatment:

Key exclusion criteria (26 listed)

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:
Infected bone diagnosed by imaging modality (e.g., Magnetic Resonance Imaging (MRI) and/or radiographic images)
Subjects whose study wound does not require debridement

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
WoundWand™ Debridement DeviceGroup I - Electrical energy that removes necrotic, ischemic, and/or infected tissue within a wound	Device	WoundWand™ Debridement Device
Standard of Care sharp debridementGroup II - Sharp instruments that remove necrotic, ischemic, and/or infected tissue within a wound	Device	Standard of Care sharp debridement

Primary outcome

Bacterial Diversity and Number of Bacteria Present in the Wound
Time frame: 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

3 secondary outcomes

Photograph Area Measurements to Determine Reduction in Wound Size
Time frame: Visit 2 through Visit 8 (12 weeks)
Wound Status Using Bates-Jensen Wound Assessment - Total Score
Time frame: Screening through Visit 8 (12 weeks)
Braden Scale for Predicting Pressure Sore Risk - Total Score
Time frame: Screening through Visit 8 (12 weeks)

Results and safety

Results posted to the registry on 28 Feb 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
WoundWand™ Debridement Device	5	3
Standard of Care Sharp Debridement	4	3

Primary outcome: Bacterial Diversity and Number of Bacteria Present in the Wound

Time frame: Day 1 (immediately pre- and post-debridement) and 4 weeks post-debridement. Number. Unit: Log^10 CFU/g

Measure	WoundWand™ Debridement Device n = 5	Standard of Care Sharp Debridement n = 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	–

Population analysed: All treated subjects

3 secondary outcomes are reported in the full results.

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.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
WoundWand™ Debridement Device	0 of 5 (0%)	4 of 5 (80%)	0 of 5
Standard of Care Sharp Debridement	0 of 4 (0%)	2 of 4 (50%)	0 of 4

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

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Luc Teot, M.D. Phd. principal investigator

Hopital Lapeyronie

Beate Hanson, MD, PhD study chair

Vice President, Global Clinical Strategy

2 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing WoundWand™ Debridement Device in people with Lower Leg Wound, run by Smith & Nephew, Inc. at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 28 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Bacterial Diversity and Number of Bacteria Present in the Wound (time frame: Day 1 (immediately pre- and post-debridement) and 4 weeks post-debridement). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01924806.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2020.