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WOUNDCHEK Bacterial Status Benefits Evaluation

NCT03678636 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2022-04-28

No results posted yet for this study

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

Interventions

DEVICE

Silver antimicrobial dressing

Silver dressing suitable for exudate level

DEVICE

Standard care

Usual care for wound type and condition

Sponsors & Collaborators

  • Pennine Care NHS Foundation Trust

    collaborator OTHER_GOV

  • Innovate UK

    collaborator OTHER_GOV

  • Greater Manchester Academic Health Science Network

    collaborator OTHER

  • Woundchek Laboratories BV

    lead INDUSTRY

Principal Investigators

  • Deborah Baines, BSc · Pennine Care NHS Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-30
Primary Completion
2019-12-05
Completion
2020-02-29

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03678636 on ClinicalTrials.gov