Journal of wound care · 2026
A wound dressing with copper and silver nanoparticles versus ionic silver hydrofibre dressing for the treatment of diabetic foot ulcers: a randomised clinical trial.
СтатьяРандомизированное исследованиеСравнительное исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Roosimaa Mart, Ilumets Helen, Kaha Tiiu, Kubo Anna-Liisa, Valkna Andres, Sihtmäe Mariliis, Kadaja Meelis, Russell David A, Bondarenko Olesja, Vasiliev Grigory
Аннотация
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 dressing group but increased in the Ag+ dressing group. The QoL score increased more in the Ag/Cu dressing group, but this difference did not reach statistical significance.
CONCLUSION: The findings of this clinical study indicated that the Ag/Cu dressing is a safe and effective way to treat infected DFUs, demonstrating faster WAS reduction, enhanced bacterial control, and higher QoL scores compared with traditional Ag+ dressings.
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 dressing group but increased in the Ag+ dressing group. The QoL score increased more in the Ag/Cu dressing group, but this difference did not reach statistical significance.
CONCLUSION: The findings of this clinical study indicated that the Ag/Cu dressing is a safe and effective way to treat infected DFUs, demonstrating faster WAS reduction, enhanced bacterial control, and higher QoL scores compared with traditional Ag+ dressings.