NCT06109844

FORCEREPAIR - A Wound Exudate Investigation

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 13 (actual)
• Sponsor: Bispebjerg Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Venous Leg Ulcer
• Wound Healing
• Non-healing Wound
• Cytokines

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-01-24
• Primary completion: 2025-10-01
• Completion: 2025-10-01
• First posted: 2023-10-31
• Last updated: 2025-12-16

Locations

2 sites across 1 country: Denmark