Effectiveness of SAP dressings for chronic wound management: a prospective single-arm clinical study

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.

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.

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.

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.

• What additional insights would a 24-week (and, ideally, 52-week) follow-up yield on durability of closure and time to first recurrence, using competing risk methods to handle events, such as amputation or death?
• How might early wound area reduction correlate with meaningful change in wound-specific quality of life?
• To what extent do objectively measured activity levels (steps/day, heel raise sets, or wearable derived walking/ standing time) modify healing rates in venous leg ulcers, beyond dressing plus compression?

Agnieszka Lipinska,1 MD, Specialist in Internal Medicine and Diabetology; Jacek Bil,2,3 MD, PhD, Cardiologist and Hypertension Specialist; Teresa Szenk,3 MSc, Statistician; Jacek Mikosinski,4 MD, PhD, Specialist in Vascular Surgery; Konrad Panczak,5 MD, PhD, Specialist in Vascular Surgery; Adam Wegrzynowski,6 MD, PhD, Specialist in Internal Medicine; Podiatry Specialist; Dorota Piechota,7 MD, PhD, Specialist in Dermatology and Venereology; Wound & Ulcer Specialist; Marek Kotala,8 MD, PhD, Specialist in Vascular Surgery; Przemyslaw Lipinski,1 MD, PhD, Specialist Surgeon; Wound Treatment Specialist; Katarzyna Rybolowicz,9 MD, Specialist in General Surgery; Patrycja Buczak,10 MSc, Managing Director of Clinical Research Organization; Anitha Pitchika,11 MSc, PhD, Clinical Evidence Manager*; Vladica Velickovic,11,12 MD, PhD, Head of Evidence Generation; David G Armstrong,13 DPM, MD, PhD, Professor of Surgery; Limb Preservation Specialist; Sebastian Probst,14,15,16,17,18 RN, PhD, Professor of Wound Care/Tissue Viability