A clinical investigation to evaluate the effect of an antimicrobial gelling fiber dressing on exudate in medium to highly exuding wounds

Non-healing, infected wounds pose a significant problem for healthcare. A new antimicrobial polyvinyl alcohol based gelling fiber dressing with silver (PVA with silver)* has antimicrobial, optimal absorptive and exudate retention properties.  
In a multi-center, prospective clinical investigation exudate and wound status were recorded over a 4 week period with weekly dressing changes performed on subjects with medium-to-highly exudative wounds.
109 patients (N=75 chronic wounds; 13 acute wounds, and 21 pressure ulcers) were recruited. 78 subjects were enrolled in PVA with silver*, 15 in PVA without silver**, and 16 in carboxymethyl cellulose (CMC) based fibre dressing with silver*** cohorts, respectively. 102 subjects completed the study (62, 11 and 12 patients from PVA with silver*, PVA without silver**, CMC with silver*** cohorts, respectively, were included in the per protocol population; 7 withdrew from the study due to non-device related reasons).
Most wounds were considered ‘wet’ at Visits 1-4. By the final Visit 5, there was a decrease in the number of wounds considered ‘wet’, with a statistically significant decrease in exudate in PVA with silver* cohort. In PVA with silver* cohort, most wounds did not have a primary dressing change due to leakage, with 40.0% of subjects having no primary dressing change for 7 days or more.
An increase in epithelialisation and a decrease in slough for all cohorts was reported by Visit 5, with a statistically significant increase in the percentage of epithelialisation (p=0.0027) in PVA with silver* cohort. 86.7% of wounds treated with PVA with silver* showed improvement or healed by Visit 5.
All investigators and patients rated the overall handling and technical performance for PVA with silver* as ‘good’ or ‘very good’ at Visit 5.
No device-related serious adverse events occurred.
PVA dressing with silver* is safe and performed well in terms of exudate handling, clinician and patient experience.
 
 

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