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Trial record 26 of 10359 for:    Anti-Infective Agents AND Bacterial

WOUNDCHEK Bacterial Status Benefits Evaluation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03678636
Recruitment Status : Recruiting
First Posted : September 19, 2018
Last Update Posted : September 19, 2018
Pennine Care NHS Foundation Trust
Innovate UK
Greater Manchester Academic Health Science Network
Information provided by (Responsible Party):
Woundchek Laboratories BV

Brief Summary:
100 chronic wounds asymptomatic for infection that test positive for bacterial protease activity (BPA) on initial screening (approx 250 wounds in total to be tested) will be randomized to intervention or control. 50 patients will receive intervention (silver antimicrobial dressing) in addition to standard care and 50 will receive standard care only (control). Wound healing at 12 weeks will be compared in addition to costs, patient quality of life, referrals to secondary care, surgical interventions, rates of infection and antibiotic use.

Condition or disease Intervention/treatment Phase
Chronic Wounds Device: Silver antimicrobial dressing Device: Standard care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 100 patients positive for BPA will be randomized to intervention or control treatment. It is anticipated approximately 200-250 patients will be tested assuming a prevalence of BPA of 40-50%.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Clinical and Economic Effectiveness of Testing Chronic Wounds for BPA (Bacterial Protease Activity) Using WOUNDCHEK Bacterial Status: A Pragmatic Randomised Clinical Trial
Actual Study Start Date : July 30, 2018
Estimated Primary Completion Date : April 30, 2019
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Intervention
The wound will be treated with a silver antimicrobial dressing appropriate for the exudate level as per manufacturer instructions for use for 2 weeks +/- 3 days, in addition to any necessary standard care (e.g. compression for a venous leg wound).
Device: Silver antimicrobial dressing
Silver dressing suitable for exudate level

Active Comparator: Control
The wound will be treated as per usual care.
Device: Standard care
Usual care for wound type and condition

Primary Outcome Measures :
  1. Mean wound area percent change [ Time Frame: 12 weeks ]
    To determine whether the use of WOUNDCHEK™ Bacterial Status to guide further management in chronic wounds improves the mean wound area reduction compared to usual care.

Secondary Outcome Measures :
  1. Proportion of wounds healed [ Time Frame: 12 weeks ]
    Compare the proportion of wounds healed between study arms

  2. Mean time to healing [ Time Frame: 12 weeks ]
    Compare mean time to healing between study arms.

  3. Total cost of care [ Time Frame: 12 weeks ]
    Aggregate cost of care including dressings, nurse visits and secondary care episodes due to the wound.

  4. Wound infections and antibiotic use [ Time Frame: 12 weeks ]
    Compare the number of wound infections and amount of antibiotic prescribing.

  5. Quality of life using EuroQol EQ-5D-5L [ Time Frame: 12 weeks ]
    EuroQoL EQ-5D-5L is a self-administered questionnaire comprised of five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has five levels:1 = no problems, 2= slight problems, 3= moderate problems, 4= severe problems, and 5 = extreme problems. A unique health state is defined by combining 1 level from each of the 5 dimensions to create a 5 digit code.

  6. Quality of life using EuroQol EQ VAS [ Time Frame: 12 weeks ]
    EuroQoL EQ VAS records the patient's self-rated health on the day of self-reporting on a vertical visual analogue scale from 0 (labelled 'The worst health you can imagine') to 100 (labelled 'The best health you can imagine'). The subscales and EQ VAS will be reported as individual dimensions in order to present any changes in the patient self-report of these health states before and after the intervention.

  7. Referral to secondary care and surgical intervention [ Time Frame: 12 weeks ]
    Compare the number of patients referred to secondary care and having surgical intervention

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Ability to give informed consent
  • Competence with English language
  • Subject has a chronic wound (venous, arterial and mixed etiology leg ulcers, diabetic foot ulcers and pressure ulcers), >1cm2 area which is not showing symptoms of infection or spreading cellulitis / lymphadenitis / lymphangitis and is not receiving treatment for local or systemic infection due to the wound.
  • Subject is 18 years of age or older.
  • Women must be of non-childbearing potential.
  • The wound is more than 4 weeks old.

Exclusion Criteria:

  • Women who are pregnant/planning a pregnancy or breastfeeding
  • The wound area is ≤1cm2.
  • The wound is obviously infected as defined by the Pennine Care Wound Management Formulary or is receiving treatment for local or systemic infection.
  • The wound has been diagnosed as being malignant.
  • Subject has hypersensitivity of the wound or painful wound surface which prevents touching / swabbing of the wound surface.
  • Subject has known allergy to silver dressings.
  • Subject is confirmed to be positive for HIV or hepatitis A, B or C.
  • Subject is pregnant and/or breastfeeding.
  • Subject is unable or unwilling to provide informed consent.
  • The wound is related to intravenous drug misuse.
  • A designated wound area may only be enrolled once in the study. For example, if an enrolled wound heals to complete closure and then re-opens, it cannot be re-enrolled in this study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03678636

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Contact: Simon W Bayliff, BSc +447917650027

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United Kingdom
Pennine Care NHS Foundation Trust Recruiting
Bury, United Kingdom, BL97TD
Contact: Deborah Baines, BSc    +447765876899   
Sponsors and Collaborators
Woundchek Laboratories BV
Pennine Care NHS Foundation Trust
Innovate UK
Greater Manchester Academic Health Science Network
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Principal Investigator: Deborah Baines, BSc Pennine Care NHS Foundation Trust

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Responsible Party: Woundchek Laboratories BV Identifier: NCT03678636     History of Changes
Other Study ID Numbers: WCL#CT/2018/001
First Posted: September 19, 2018    Key Record Dates
Last Update Posted: September 19, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to make IPD available.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Anti-Infective Agents
Anti-Bacterial Agents