A Silver-Zeolite Spray Powder for Pressure Ulcers and Minor Burns: Real-World Evidence from Primary Care

Lorel Mureșan,1 Dionisio Franco Barattini,2 Laura Simona Ianoși,3 Carlo Signorini,4 Rawia Harb51Medical Department, S.C. Salvosan Ciobanca, Zalău, Romania; 2Medical Department, Opera CRO, a Tigermed Company, Timișoara, Romania; 3Medical Department, Centrul Medical Dr. Ianosi S.R.L., Craiova, Romania; 4QA Department, Signorini Medicale S.R.L., Albaredo d’Adige, Italy; 5Clinical Operations Department, Tigermed Italy S.R.L., Genova, ItalyCorrespondence: Dionisio Franco Barattini, Medical Department, Opera CRO, a Tigermed company, Strada Cozia nr. 10, Timișoara, 300209, Romania, Email [email protected]: Pressure ulcers and minor burns are commonly managed in primary care. The tested device is an adsorbing spray powder combining ionic silver (2.5%) and micronized zeolite (97.5%), designed to provide exudate control and antimicrobial activity in a topical formulation.Materials and Methods: In this multicenter, open-label, single-arm post-market clinical follow-up (PMCF) study, adult outpatients with chronic stage II–III pressure ulcers (NPUAP) unhealed after ≥ 3 weeks of standard care, or with superficial/partial-thickness burns (< 10% body surface area) within 48 hours of injury, received the tested product for 4 weeks. Co-primary endpoints were 4-week changes in PUSH (pressure ulcers) and Vancouver Scar Scale (VSS; burns) scores; secondary endpoints included pain (100-mm Visual Analog Scale), patient satisfaction, Investigator Global Assessment of Performance, and safety.Results: Fifty-eight patients were enrolled and 56 analyzed per-protocol (32 burns, 24 pressure ulcers); two discontinued for reasons unrelated to safety. At Week 4, 96.4% (54/56) showed meaningful improvement and none worsened. Mean VSS decreased from 5.22± 2.78 to 1.31± 1.49 in burns (p< 0.001; bias-corrected d_avg=1.72), and mean PUSH decreased from 11.67± 2.41 to 3.29± 1.60 in pressure ulcers (p< 0.001; bias-corrected d_avg=4.01), with 95.8% of pressure-ulcer patients achieving a ≥ 5-point reduction. VAS pain decreased from Week 2 in both subgroups (p< 0.001). At Week 4, the Investigator considered 68.8% of burns and 29.2% of pressure ulcers healed. Patient satisfaction was high (75.0% very satisfied, 25.0% satisfied); no adverse events, device effects or deficiencies were reported.Conclusion: In this single-arm, real-world study, the tested device showed a favorable performance and safety signal in mild-to-moderate pressure ulcers and minor burns; given the non-comparative design, these findings do not establish equivalence or superiority to other silver-based dressings. Ease of use may support outpatient self-managed care; adequately powered randomized trials versus alternative silver-based dressings are warranted to confirm these findings.Trial Registration: ClinicalTrials.gov, NCT05649332.Keywords: pressure ulcers, burn wounds, silver ions, zeolite, wound healing, primary care, real-world evidence