The primary objective of the study is to determine sensitivity, specificity, positive and negative predictive value of the enzyme analyses (myeloperoxidase, human neutrophil elastase and lysozyme) with wound biopsies as the gold standard.…
ID
Source
Brief title
Condition
- Bacterial infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Sensitivity, specificity, positive and negative predictive value and the AUC of
the enzyme analyses with wound biopsies as gold standard are the main study
parameters.
Secondary outcome
To determine the clinical relevance of the enzyme analyses, the diagnostic
properties of both wound swab and clinical judgment, when compared to wound
biopsies, will be calculated.
Furthermore, the enzyme analyses should point out what enzymes are present in
the wound fluid.
The types of bacteria that causes the infection is identified from wound biopsy
Background summary
The current diagnostic methods to identify infection in chronic wounds are
based on clinical judgment and, when wound infection is suspected, a wound swab
for microbiological analysis. The gold standard, wound biopsy, is only used in
rare cases. However, these current diagnostic methods seem unreliable (clinical
judgment) or provide results only after a couple of days (cultures). Late
diagnosis of wound infection can result in hospitalization and, in worst cases,
sepsis. A new diagnostic tool, the InFact, is based on the identification of
the enzymes myeloperoxidase, human neutrophil elastase and lysozyme that are
proven to play a role in the inflammation process. Using these enzyme analyses
has the potential to detect wound infection both fast and accurate.
Study objective
The primary objective of the study is to determine sensitivity, specificity,
positive and negative predictive value of the enzyme analyses (myeloperoxidase,
human neutrophil elastase and lysozyme) with wound biopsies as the gold
standard. Furthermore, microbiological analysis based on wound swabs and the
clinical judgment will be compared with the biopsy results.
Study design
This diagnostic study is designed as a cross-sectional study.
Study burden and risks
For patients, participation in this study consists of a onetime assessment
during a regular appointment. Clinical judgment and wound swabs for
microbiological analysis are part of regular care. Only when wound infection is
not expected based on clinical judgment, wound swab for microbiological
analyses can be seen as additional test. No risks are associated with the
clinical judgment, the wound swab for microbiological analysis and the
additional wound swab enzyme analysis.
The wound biopsy that is taken for this study might cause local bleeding. In
this study, patients at risk of uncontrolled bleeding are excluded. In case
there is bleeding of the wound, adequate haematosis will be achieved through
covering the wound with calcium alginate gauze and, if necessary, with a
pressure dressing. Furthermore, patients might experience some pain during the
wound biopsy. To minimize this pain, the wound will be anesthetized before
biopsy with Lidocaine drops if necessary.
Haaksbergerstraat 55
Enschede 7513 ER
NL
Haaksbergerstraat 55
Enschede 7513 ER
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL43733.044.13 |
| OMON | NL-OMON26712 |