FORCEREPAIR - A Wound Exudate Investigation

Bispebjerg Hospital13 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Venous Leg Ulcer Wound Healing Non-healing Wound Cytokines

Interventions

Standard of CareOTHER

Patients enrolled in this observational study receive standard of care. Treatment, ointments, compression and bandages will be registered at every visit.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Danish Wound Healing Center, Bispebjerg Hospital

Copenhagen, Northwest, Denmark

Vascular Research Unit and Department of Vascular Surgery, Viborg Regional Hospital

Viborg, Denmark

Outcomes

Primary Outcomes

Wound Exudate Effects on Proliferation of Healthy Primary Human Fibroblasts

Proliferation

Time frame: Four weeks

Wound Exudate Effects on Matrix Formation by Healthy Primary Human Fibroblasts

Matrix Formation

Time frame: Four weeks

Wound Exudate Effects on Release of Pro-inflammatory Mediators

Release of pro-inflammatory Mediators

Time frame: Four weeks

Wound Exudate Effects on Cellular Gene Expression Profiles In Healthy Primary Human Fibroblasts

Gene Expression Profiles

Time frame: Four weeks

Exploratory Wound Exudate Compound and Device Testing

Wound Exudate Compounds

Time frame: Four weeks

Secondary Outcomes

Wound Exudate Profile Relation to Percentage Area Reduction

Time frame: Four Weeks

Wound Exudate Profile Relation to Wound Microbiome Profile

Time frame: Four Weeks

Percentage Area Reduction Relation to Wound Microbiome Profile

Time frame: Four Weeks

Comparisson of Wound Exudate Sampling Techniques

Polyurethane disc twenty-four-hour sampling, Bandages and NovaSwabs

Time frame: Four Weeks

Data from ClinicalTrials.gov

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