Efficacy of Prontosan Solution on Chronic Ulcers

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy of Prontosan® Wound Irrigation Solution compared with standard isotonic solution on infammation reduction and wound bed cleansing of chronic pressure or vascular leg ulcers.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Associazione Infermieristica per lo studio delle Lesioni Cutanee
• Collaborator: B. Braun Medical SA
• Treatments: Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• Male and females aged at least 18 with Pressure ulcer stage 2-3 NPUAP (National Pressure Ulcer Advisory Panel 1989)or subcutaneous vascular ulcer with inflammation and/or biofilm and/or slough

• Braden index at baseline>=10

• Ulcer area<80 cm2

• Ability to give an informed consent

Exclusion Criteria:

• Braden index at baseline<10

• Current therapy with corticosteroids or immunosuppressor or radiotherapy

• Sensitivity to any of the components of Prontosan® Solution

• Diabetic foot ulcer

• Current use of local antiseptics on the wound bed

• Previous recruitment of another ulcer in the trial