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

Launched by LOHMANN & RAUSCHER · Dec 2, 2022

Keywords

ClinConnect Summary

This clinical investigation will be conducted as 3 weeks, multicentre, open, single-arm cohort study on patients presenting wounds at risk of infection or infected wounds. All wounds of the included patients will be treated with Suprasorb® A +Ag Antimicrobial Calcium Alginate Wound Dressings (and Suprasorb® A + Ag Antimicrobial Calcium Packing Rope - if required by the depth of the wound).

At inclusion visit (V1, day 0), interim visit (V2, after 10 days ±3 days) and termination visit (V3 after 21 days ±3 days or earlier; as soon as the wound is epithelialized completely) patients will have...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age ≥ 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 ≥ 5) or a wound with risk of infection (W.A.R. Score ≥ 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 Suprasorb® 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 Suprasorb® 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 compliant regarding treatment of the underlying disease (e.g. compression)
• • Dry wound
• • Pregnancy or breast feeding
• • Reliable severe malnutrition
• • Patient is analphabet
• • Participation in any clinical trial within the last 1 month and during participation in this study
• • Legal incapacity