A Study Into The Diagnostic Properties Of A New Device For Rapid Bedside Testing Of Infection In Chronic Wounds: The INFACT 2.0 study

Completed

Conditions: wound infection
wound inflammation
10004018

Registration Number: NL-OMON40347

Lead Sponsor: Medisch Spectrum Twente

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 180

Inclusion Criteria

Open chronic wound (>3 weeks); this will be mainly
o Diabetic foot ulcer
o Arterial or venous leg ulcer
o Pressure ulcer
o Operation wounds, healed by secundary intention or wound dehiscention.
>=18 years of age
Patients from the department of Surgery (MST, ZGT, St Jansdal, SKB) or Dermatology (MST), or from Livio home care

Exclusion Criteria

• Use of antibiotics in the last five days
• Malignant wounds
• Fully necrotic wounds
• Fully dry wounds; no production of wound fluid in last 2 days.
• Allergy or hypersensitivity for Lidocaine, when local anaesthesia is necessary. This will be based on self-reported allergy or hypersensitivity by the patient.
• Wounds that are completely covered with exposed periosteum
• Wounds with a diameter < 3 millimetres
• Facial wounds
• Haematological disorders with risk of uncontrolled bleeding
• INR > 4
• MRSA or ESBL positive
• Additional exclusion criteria for Livio home care; wounds that are not located on extremities

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Sensitivity, specificity, positive and negative predictive value and the AUC of<br /><br>the enzyme analyses with wound biopsies as gold standard are the main study<br /><br>parameters.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To determine the clinical relevance of the enzyme analyses, the diagnostic<br /><br>properties of both wound swab and clinical judgment, when compared to wound<br /><br>biopsies, will be calculated.<br /><br><br /><br>Furthermore, the enzyme analyses should point out what enzymes are present in<br /><br>the wound fluid.<br /><br>The types of bacteria that causes the infection is identified from wound biopsy</p><br>