FORCEREPAIR - A Wound Exudate Investigation

Study Overview
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Brief Summary
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The observational longitudinal study will collect wound exudate from twenty patients with venous leg ulcers. Wound exudate samples are collected using twenty-four-hour collection with polyurethane foam, bandages and the NovaSwab method. Each patient is seen four times where wound exudate and the bacteria microbiome are sampled and wound size is monitored with advanced planimetric tools.

Detailed Description
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This dual centre longitudinal observational study will run from January 2024 to January 2025. The investigation will include twenty patients over four weeks including four study visits. Sampling of wound exudate can take place on every visit and will be made with the polyurethane discs, the NovaSwab technique and waste bandages. The wound bacteria microbiome is sampled with routine bacterial swabs. Tape strips will be used to assess perilesional skin and control sites of normal skin and will primarily measure skin inflammation parameters. Clinical pictures are taken and analysed using advanced planimetric tools. Patients enrolled receive standard wound care; allowing all kinds of dressing. However when consenting to twenty-four-hour-collection patients will not be allowed to wear active bandages or receive antibiotic treatment for that period. Compression, wound dressings, and use of topical and oral antibiotics will be registered. For the storage of samples, a research biobank is used, and leftover material will be stored in a biobank for future research.

Official Title
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FORCEREPAIR - A Wound Exudate Investigation

Conditions
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Venous Leg Ulcer, Wound Healing, Non-healing Wound, Cytokines

Intervention / Treatment
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* Other: Standard of Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults fulfilling all inclusion criteria Age >18 years Venous leg ulcer diagnosis and classic characteristics (localisation, varicose veins, brown-orange hyperpigmentation, leg oedema, stasis dermatitis, atrophie blanche or lipodermatosclerosis) verified by a wound expert (if in doubt venous doppler will be used for verification) Wound Area equal to or above 1 cm2 (measured with a ruler length x width) Patient can understand Danish Patient can comply with protocol Patient is fully informed about the study and has given informed consent Exclusion Criteria: Venous leg ulcer with communication to bone Known or suspected cancer in the wound Allergies towards products used in the study, e.g. polyurethane foam and tegaderm Dementia Judgement by the investigator that the patient is not suited for study participation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Standard of Care|Patients enrolled in this observational study receive standard of care. Treatment, ointments, compression and bandages will be registered at every visit.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound Exudate Effects on Proliferation of Healthy Primary Human Fibroblasts | Proliferation | Four weeks | 
| Wound Exudate Effects on Matrix Formation by Healthy Primary Human Fibroblasts | Matrix Formation | Four weeks | 
| Wound Exudate Effects on Release of Pro-inflammatory Mediators | Release of pro-inflammatory Mediators | Four weeks | 
| Wound Exudate Effects on Cellular Gene Expression Profiles In Healthy Primary Human Fibroblasts | Gene Expression Profiles | Four weeks | 
| Exploratory Wound Exudate Compound and Device Testing | Wound Exudate Compounds | Four weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound Exudate Profile Relation to Percentage Area Reduction |  | Four Weeks | 
| Wound Exudate Profile Relation to Wound Microbiome Profile |  | Four Weeks | 
| Percentage Area Reduction Relation to Wound Microbiome Profile |  | Four Weeks | 
| Comparisson of Wound Exudate Sampling Techniques | Polyurethane disc twenty-four-hour sampling, Bandages and NovaSwabs | Four Weeks | 
| Wound Microbiome 16 rRNA/18sRNA | Bioburden, Diversity and Pathogens | Four Weeks | 
| Wound Perilesional Skin Inflammation | Tape Strips from perilesional skin and control site. | Four Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Venous Leg Ulcer, Varicose Ulcer, Cytokines, Wound Exudate, Wound Healing, Wound Inflammation, Wound Microbiome