Biatain Ag vs Biatain in the Treament of Leg Ulcers

Clinical Assessment of Biatain Ag Dressings Compared to Biatain Dressings in the Treatment of Leg Ulcers

the objective of this investigation is to demonstrate the effect of the foam dressing Biatain Ag, compared to Biatain foam dressing( a product which is similar but does not contain a silver complex, in the healing of leg ulcers that had failed to heal despite appropriate therapy

Inclusion Criteria:

• • Patients over 18 who have given written informed consent

  • Patients with a venous or predominantly venous leg ulcer (ankle-brachial index > 0.8) that is between 2 cm and 13 cm in all directions
  • Patients with a moderately or severely exudating leg ulcer in the phase of debridement or formation of granulation tissue
  • Patients with a leg ulcer that is not healing properly despite suitable and well-conducted local treatment in the four weeks prior to inclusion
  • Patients with a leg ulcer that has been treated with appropriate compression in the four weeks prior to inclusion
  • Patients who are available for monitoring for at least 10 weeks

Exclusion Criteria:

• • Patients whose leg ulcers are clinically infected (including erysipelas and cellulitis of the skin around the ulcer) requiring systemic antibiotic treatment

  • Patients who have undergone surgery on the saphenous trunk within the two months prior to inclusion
  • Patients whose leg ulcer being considered for the study has been treated with local antibiotics or antiseptics incl. dressings containing antibiotics or antiseptics in the four weeks prior to inclusion
  • Patients who have been taking systemic antibiotics in the two weeks prior to inclusion
  • Patients who have been taking systemic corticoids or cytostatics within the three months prior to inclusion
  • Patients with unbalanced diabetes at the discretion of the investigator
  • Patients with a known allergy to one of the components in Biatain Argent® or Biatain
  • Patients who are already taking part in another clinical study
  • Patients who are pregnant or breastfeeding