SuprasorbĀ® A + Ag in the Treatment of Wounds at Risk of Infection and Infected Wounds (NCT05646121) | Clinical Trial Compass
CompletedNot Applicable
SuprasorbĀ® A + Ag in the Treatment of Wounds at Risk of Infection and Infected Wounds
Poland99 participantsStarted 2022-09-13
Plain-language summary
The aim of this post market clinical follow up (PMCF) study is to confirm the performance of SuprasorbĀ® 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 SuprasorbĀ® A + Ag wound dressing and rope within the certified indications and under the conditions of routine use.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ā„ 18 years
* Patient is legally capable
* Presence of a heavily exuding wound
* Presence of one of the following wounds:
* pressure ulcers
* arterial ulcers
* venous lower leg ulcers
* diabetic ulcers OR
* postoperative wound
* skin graft and donor sites
* Infected wound (TILI Score ā„ 5) or a wound with risk of infection (W.A.R. Score ā„ 3)
* Wound area between 4 and 100 cm2
* It must be possible to display the entire wound area on one photo from a distance of 25-30 cm
* Patient has signed a written Informed Consent
Exclusion Criteria:
* Treatment with SuprasorbĀ® A + Ag Antimicrobial Calcium Algi-nate Wound Dressing and Rope or any silver containing dressing or topical drug during the last 3 weeks
* Known sensitivity to SuprasorbĀ® A + Ag Antimicrobial Calcium Alginate Wound Dressing and Rope or any of their components
* Malignant wounds (tumor related wounds)
* Critical limb ischemia
* Infected 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 months
* A planned surgical operation in the region of the study wound within the next 4 weeks following inclusion
* Patient is not compliā¦