An Innovative Mesh-Free Healing Matrix Dressing: Clinical Trial Results
Summary: This four-week prospective multicentre clinical trial evaluated the performance and local tolerance of UrgoFit, an innovative mesh-free contact layer dressing made of lipidocolloid technology (TLC), in 78 adults with granulating acute, chronic, or epidermolysis bullosa (EB) wounds. Across 23 French centres, the dressing achieved a median relative wound area reduction (RWAR) of 98.2% at week 4, with 49% complete closure (median time-to-heal 16.5 days). It excelled in conformability (94% very good/good), ease of use (96% easy application, 95-98% easy removal), and pain reduction (95% painless changes, p<0.0001 vs. prior dressings), while preserving new tissue in 100% of cases. Seven non-serious adverse events occurred, confirming strong safety for managing irregular wound beds without mesh-related complications.
Key Highlights:
- Median RWAR 98.2% at week 4 across wound types (61.5-100.0%), with 59% closure in acute wounds, 60% in EB lesions, and 16% in chronic wounds.
- Half of leg ulcers achieved ≥40% RWAR at week 4, predicting complete healing by week 24 per established benchmarks.
- Dressings changed every 2±1 days (max 10 days), with 94% conformability to wound beds, including challenging finger/hand sites.
- Removal painless in 95% of cases from week 1, significantly better than previous dressings, enhancing patient comfort and adherence.
- Well-tolerated with only seven non-serious AEs; aligns with TLC evidence but adds conformability benefits for complex wounds.
Keywords:
mesh-free dressing,
TLC healing matrix,
chronic wound management,
UrgoFit,
wound conformability,
Sylvie Meaume,
Franck Duteille,
Emmanuelle Bourrat