Background: Removal of negative-pressure wound therapy (NPWT) devices often induce pain which could be a limitation of their use.
Purpose: The aim of this trial was to evaluate the protection afforded by the Urgotul lipido-colloid dressing combined with the VAC (NPWT) system in the management of acute or chronic wounds, through a prospective, multicenter non-comparative trial conducted open-label, in 8 investigating centers comprising hospital units of Plastic and Reconstructive Surgery, Vascular Surgery, General Surgery and Dermatology.
Methods: Patients were followed up by the investigating physician each time the VAC-Urgotul combination was changed, using the pain parameter as the primary judgment criteria. This included clinical evaluation and photographs (with measurement of wound size and depth at the start and end of the treatment). The follow-up was completed at the convenience of the investigator and lasted until use of the NPWT system was no longer justified.
Results: 66 patients were included (42 acute wounds and 24 chronic wounds) and followed up for an average of 17 days. Dressing changes were deemed entirely painless in 52% of cases (vs 18% at baseline) and spontaneous pain was absent in 66% of cases (vs 34% at inclusion). Overall removal of the VACfoam-dressing was considered very easy or easy in 94% of cases and adherence of the VAC®-Urgotul® combination to the wound was recorded as "absent" in 88%.
On average the dressings were changed every 3.8-1.1 days (all wounds considered) and wound size/depth were reduced by 19% and 54% respectively by the end of the follow-up period.
Conclusion: The Urgotul lipido-colloid dressing used in this clinical evaluation showed that its combination with the NPWT substantially reduced pain caused by dressing changes. It therefore renders greater acceptability of NPWT procedure which aims to optimize the wound healing process of these wounds which often need to be grafted.