Suprasorb® A + Ag in the Treatment of Wounds at Risk of Infection and Infected Wounds

The aim of this post market clinical follow up (PMCF) study is to confirm the performance of Suprasorb® A + Ag wound dressing and rope, to collect safety data regarding expected adverse events and to detect potential unexpected adverse events associated with use of Suprasorb® A + Ag wound dressing and rope within the certified indications and under the conditions of routine use.

Inclusion Criteria:Age ≥ 18 yearsPatient is legally capablePresence of a heavily exuding woundPresence of one of the following wounds:pressure ulcersarterial ulcersvenous lower leg ulcersdiabetic ulcers ORpostoperative woundskin graft and donor sitesInfected wound (TILI Score ≥ 5) or a wound with risk of infection (W.A.R. Score ≥ 3)Wound area between 4 and 100 cm2It must be possible to display the entire wound area on one photo from a distance of 25-30 cmPatient has signed a written Informed ConsentExclusion Criteria:Treatment with Suprasorb® A + Ag Antimicrobial Calcium Algi-nate Wound Dressing and Rope or any silver containing dressing or topical drug during the last 3 weeksKnown sensitivity to Suprasorb® A + Ag Antimicrobial Calcium Alginate Wound Dressing and Rope or any of their componentsMalignant wounds (tumor related wounds)Critical limb ischemiaInfected wounds requiring systemic antibiotic therapy at baseline visit or infected wounds with surrounding skin requiring local an-tibiotics at baseline visit and/or during study conduct.Severe sensitive neuropathy (9-10 points on the Neuropathie-Symptom-Score (Diagnose und Therapie der sensomotorischen diabetischen Neuropathien. Diabetes und Stoffwechsel, 11, Suppl.2 (2002))Planned amputation within the next 1 monthsA planned surgical operation in the region of the study wound within the next 4 weeks following inclusionPatient is not compliant regarding treatment of the underlying disease (e.g. compression)Dry woundPregnancy or breast feedingReliable severe malnutritionPatient is analphabetParticipation in any clinical trial within the last 1 month and during participation in this studyLegal incapacity