WOUNDCHEK Bacterial Status Benefits Evaluation
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|ClinicalTrials.gov Identifier: NCT03678636|
Recruitment Status : Recruiting
First Posted : September 19, 2018
Last Update Posted : September 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|Chronic Wounds||Device: Silver antimicrobial dressing Device: Standard care||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||250 participants|
|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)|
|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|
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
- 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.
- Proportion of wounds healed [ Time Frame: 12 weeks ]Compare the proportion of wounds healed between study arms
- Mean time to healing [ Time Frame: 12 weeks ]Compare mean time to healing between study arms.
- Total cost of care [ Time Frame: 12 weeks ]Aggregate cost of care including dressings, nurse visits and secondary care episodes due to the wound.
- Wound infections and antibiotic use [ Time Frame: 12 weeks ]Compare the number of wound infections and amount of antibiotic prescribing.
- 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.
- 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.
- Referral to secondary care and surgical intervention [ Time Frame: 12 weeks ]Compare the number of patients referred to secondary care and having surgical intervention
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 ClinicalTrials.gov identifier (NCT number): NCT03678636
|Contact: Simon W Bayliff, BScemail@example.com|
|Pennine Care NHS Foundation Trust||Recruiting|
|Bury, United Kingdom, BL97TD|
|Contact: Deborah Baines, BSc +447765876899 firstname.lastname@example.org|
|Principal Investigator:||Deborah Baines, BSc||Pennine Care NHS Foundation Trust|