Biatain Ag vs Biatain in the Treament of Leg Ulcers

Coloplast

Status: Completed

Conditions: Leg Ulcers

Treatments: Device: Biatain; Device: Biatain Ag

Study type: Interventional

Funder types: Industry

Identifiers

NCT00807664

FR008WS

Details and patient eligibility

About

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

Enrollment: 182 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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182 participants in 2 patient groups

1

Experimental group

Description:

Biatain Ag dressing

Treatment:

Device: Biatain Ag

2

Active Comparator group

Description:

Biatain dressing

Treatment:

Device: Biatain