Effectiveness of silicone superabsorbent polymer dressings for chronic wound management: a prospective single-arm clinical study

OBJECTIVE: This study evaluated the effectiveness of silicone superabsorbent polymer (SAP) dressings in patients with venous leg ulcers (VLUs) and diabetic foot ulcers (DFUs), with emphasis on wound area reduction (WAR) and improvement in wound bed characteristics over a six-week observation period. METHOD: This prospective, single-arm study evaluated two silicone SAP dressings-RespoSorb Silicone Border (RSSB; also marketed as Zetuvit Plus Silicone Border) and RespoSorb Silicone (RSSil; also marketed as Zetuvit Plus Silicone) (both PAUL HARTMANN AG, Germany)-in patients with exuding VLUs or DFUs across eight clinical sites in Poland. The primary endpoint was relative WAR, measured using centralised digital planimetry, with ≥20% WAR defined as clinically meaningful. Secondary endpoints included: complete re-epithelialisation; changes in granulation and slough tissue composition; exudate management; periwound skin condition; dressing wear time; and safety. RESULTS: A total of 80 patients took part in this study. Participants were predominantly male (62.5%) with a mean age of 67.1 years; 53 received RSSB and 27 received RSSil. At the final visit, ≥20% WAR was achieved in 59/79 (74.7%) patients before cleansing/debridement and in 66/79 (83.5%) after cleansing/debridement (p<0.001 for superiority) (one baseline image for both before and after cleansing/debridement was missing and unavailable for planimetry assessment). The median relative WAR was 69.6% (interquartile range (IQR): 28.9-100%) following cleansing/debridement. The median granulation tissue coverage decreased by 75.2% (IQR: 24.3-100%) and slough coverage decreased by 98.6% (IQR: 46.7-100%) after cleansing/debridement, while median exudate volume reduced by 0.38ml (IQR: -0.1-1.75ml) from baseline (all p<0.001). Complete re-epithelialisation occurred in 21/80 (26.9%) patients. Median dressing wear time was four days (IQR: 3-6 days) over all six follow-up visits. CONCLUSION: In this study, the two silicone SAP dressings used demonstrated clinically meaningful improvement in wound outcomes in chronic VLUs and DFUs, with most patients achieving ≥20% WAR alongside effective exudate management and improved wound bed quality.