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

Study Overview

• Status: Completed
• Conditions: Leg Ulcers
• Intervention / Treatment: Device: Biatain Ag; Device: Biatain

• Study Type: Interventional
• Enrollment (Actual): 182
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Biatain Ag dressing	Device: Biatain Ag; Biatain Ag non adhesive ( ColoplastA/S), a polyurethane permeable backing film with an added silver complex, size 15X15. The product is CE marked
Active Comparator: 2; Biatain dressing	Device: Biatain; A standard polyurethane foam dressing Biatain non adhesive permeable backing film, size15X15 cm. the product is CE marked

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage Change of the Leg Ulcer Area Measured by Planimetry at Week 6 Compared to the Ulcer Area at Baseline	The measure of the ulcer was to measure its greatest lenght and width with these two axes being at right angles. An average of three measurements was to calculated the area of the ulcer by the equation: Area= Lenght *Width * pi [3.142] / 4 All planimetry records (using double-sided tracing paper) were centrally assessed and read by a blinded person not aware of which treatment that was used.	Day 0 to Day 42

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage Change of the Leg Ulcer Area Measured by Planimetry at Week 10 Compared to the Ulcer Area at Baseline	The measure of the ulcer was to measure its greatest lenght and width with these two axes being at right angles. An average of three measurements was to calculated the area of the ulcer by the equation: Area= Lenght *Width * pi [3.142] / 4 All planimetry records (using double-sided tracing paper) were centrally assessed and read by a blinded person not aware of which treatment that was used.	Day 0 to Day 70
Total Number of Adverse Events		Day 0 to Day 70

Collaborators and Investigators

• Sponsor: Coloplast A/S

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Actual): April 1, 2010
• Study Completion (Actual): April 1, 2010

Study Registration Dates

• First Submitted: December 11, 2008
• First Submitted That Met QC Criteria: December 11, 2008
• First Posted (Estimate): December 12, 2008

Study Record Updates

• Last Update Posted (Actual): January 16, 2018
• Last Update Submitted That Met QC Criteria: January 11, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Skin Ulcer; Ulcer; Leg Ulcer
• Other Study ID Numbers: FR008WS