A wound dressing with copper and silver nanoparticles versus ionic silver hydrofibre dressing for the treatment of diabetic foot ulcers: a randomised clinical trial
Abstract
Objective: The objective of this trial was to compare the clinical performance and safety of a novel wound dressing containing silver and copper nanoparticles (Nanordica; Nanordica Medical OÜ, Estonia) (Ag/Cu) with the ionic silver-based dressing Aquacel Ag+ Extra (Convatec Group, UK) (Ag+) for the treatment of infected diabetic foot ulcers (DFUs).
Method: This study was a single-blinded, randomised, active-controlled pilot trial involving patients with infected DFUs who were randomly assigned to receive either the Ag/Cu or Ag+ dressing. Patients were treated over a one-week active phase with dressing changes every other day, followed by a two-week follow-up phase using a non-antibacterial dressing. Efficacy was measured by wound area size (WAS) reduction, bacterial load control and quality of life (QoL) scores. Safety outcomes were based on adverse events and blood Ag levels.
Results: The experimental cohort included 30 patients. Consistently better results were observed in nearly all efficacy and safety endpoints for patients treated with the Ag/Cu dressing compared with those treated with the Ag+ dressing. Although WAS decreased in both groups, the WAS in the Ag/Cu dressing group had already decreased by 31% after the first dressing change. By the end of the active phase, the WAS had decreased by 43% in the Ag/Cu dressing group, compared with a 13% reduction in the Ag+ dressing group. The mean total bacterial load in the wound bed did not change significantly in the Ag/Cu…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 30 participants or records.
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