Randomized Controlled Trial Comparing Collagen/Oxidized Regenerated Cellulose/Silver to Standard of Care in the Management of Venous Leg Ulcers

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Abstract

OBJECTIVE:

To assess healing outcomes in venous leg ulcers (VLUs) treated with a combination of collagen, oxidized regenerated cellulose, and silver in conjunction with standard of care (SOC; intervention group) compared with SOC alone (control group). Standard of care included ADAPTIC nonadhering dressing (Acelity, San Antonio, Texas) and compression.

DESIGN AND SETTING:

Randomized controlled trial that followed patients in 3 US facilities for 12 weeks or until complete healing.

PATIENTS AND INTERVENTION:

Forty-nine patients with VLUs were randomized to either the intervention group (n = 22) or the control group (n = 27).

MAIN OUTCOME MEASURE:

Wound healing over 12 weeks.

MAIN RESULTS:

Intent-to-treat analysis showed a mean percentage wound area reduction at 12 weeks of 85.6% (SD, 28.6%) for the intervention group and 72.5% (SD, 77.8%) for the control group. There was a higher healing rate in the intervention group compared with patients who received SOC only at both week 4 (23% vs 11%) and week 12 (64% vs 59%). There were no adverse events related to the study therapy.

CONCLUSIONS:

Although the results were not significant, there was a trend toward faster healing in the intervention group. The results of this study indicate that collagen/oxidized regenerated cellulose/silver is a suitable and safe adjunctive intervention for use with SOC to manage VLUs.

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