An open label,single-centric,post market clinical study to evaluate the safety and efficacy of a new antimicrobial wound dressing (VELVERT) as an adjuvant therapy in the treatment of venous leg ulcer

Abstract

Objectives

An open label, single-centric, post market clinical study was undertaken to evaluate the safety and efficacy of a new antimicrobial wound dressing (VELVERT) as an adjuvant therapy in the treatment of venous leg ulcer (VLU).

Methods

Patients with VLU of grade C-5 according to CEAP classification and above were evaluated using doppler ultra sound. The efficacy of new antimicrobial wound dressing (VELVERT) was assessed in terms of wound area reduction within a time frame of 60 days and surgeon questioners. Patients were evaluated for VELVERT safety and pain level on a scale of 0-10 Numeric Pain Chart. Presence of micro-organism load was monitored at regular time interval.

Results

VELVERT treatment was effective as 71.43% reduction in the ulcer area was observed. After 60 days, a total of 9 (45%) patients had complete ulcer closure. A remarkable decrease in the severity of pain was observed with 11 (55%) patients expressing no pain at the EOT. Swab test showed negative result for micro-organism growth. No serious adverse events were observed during the trial.

Conclusion

The data indicates that VELVERT is an effective treatment for VLUs and showed the potential in the wound care of VLUs.

Keywords

Venous leg ulcers antimicrobial dressing adjuvant therapy biocompatible

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