Clinical performance and safety of a debridement pad with abrasive and non-abrasive fibres.

Abstract

Background: Debridement is key to removing devitalised tissue, debris and biofilm as part of wound-bed preparation. Unlike many other methods of debridement, mechanical debridement with a pad is effective enough to be used independently without an adjunctive method of debridement, while being more accessible than other standalone options.

Objective: To explore the clinical performance and safety of a debridement pad with both abrasive and non-abrasive surfaces in daily clinical practice.

Methods: This was a prospective, non-controlled, non-randomised, single-arm, open-label, multicentred observational evaluation. Inclusion criteria were wounds >4 cm² covered with at least 30% debris, necrotic tissue or slough in patients aged ≥18 years. The treatment protocol comprised a single application of the debridement pad. The primary outcome measure was the amount of necrotic tissue, slough or debris in the wound bed. Secondary outcomes included the appearance of the wound bed, edges and periwound skin; self-reported pain scores; foreseeable negative impacts; and clinician satisfaction.

Results: A total of 62 participants with a variety of wound types were included in the analysis. Most wounds (87%) had been present for over 3 months and had high or moderate exudate levels (90%). A significant reduction was observed in all three parameters: necrotic tissue (p=0.043), slough (p<0.001) and debris (p<0.001). Necrotic tissue, slough and debris showed mean relative reductions of 40%, 72% and 40%, respectively. Of participants, 84% did not experience an increase in pain during the debridement procedure.

Conclusion: This clinical real-world data shows the debridement pad to be an effective and well-tolerated device for debridement and wound bed preparation.