WOUNDCHEK Bacterial Status Benefits Evaluation

NCT03678636 | Completed

• 1 other identifier: WCL#CT/2018/001
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Wounds

Outcome Measures

Primary Outcomes (1)

• Mean wound area percent change

  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.

  12 weeks

Secondary Outcomes (7)

• Proportion of wounds healed

  12 weeks

• Mean time to healing

  12 weeks

• Total cost of care

  12 weeks

• Wound infections and antibiotic use

  12 weeks

• Quality of life using EuroQol EQ-5D-5L

  12 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

ACTIVE COMPARATOR

The wound will be treated as per usual care.

Device: Standard care

Interventions

Silver antimicrobial dressing DEVICE

Silver dressing suitable for exudate level

Intervention

Standard care DEVICE

Usual care for wound type and condition

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Woundchek Laboratories BV: lead
• Pennine Care NHS Foundation Trust: collaborator
• Innovate UK: collaborator
• Greater Manchester Academic Health Science Network: collaborator

Study Sites (1)

Pennine Care NHS Foundation Trust

Bury, BL97TD, United Kingdom

Location

Study Officials

• Deborah Baines, BSc

  Pennine Care NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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%.

Study Record Dates

• First Submitted: September 11, 2018
• First Posted: September 19, 2018
• Study Start: July 30, 2018
• Primary Completion: December 5, 2019
• Study Completion: February 29, 2020
• Last Updated: April 28, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)