Suprasorb® A + Ag in the Treatment of Wounds at Risk of Infection and Infected Wounds
Launched by LOHMANN & RAUSCHER · Dec 2, 2022
Trial Information
Current as of January 21, 2025
Completed
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
Trial Officials
Claudia Feldkamp, Dr.
Study Director
Lohmann & Rauscher
About Lohmann & Rauscher
Lohmann & Rauscher is a leading global provider of innovative medical and hygiene products, specializing in wound care, compression therapy, and surgical solutions. With a commitment to enhancing patient outcomes through advanced research and development, the company focuses on delivering high-quality, effective products that meet the evolving needs of healthcare professionals and patients alike. Established with a strong emphasis on sustainability and safety, Lohmann & Rauscher actively engages in clinical trials to advance medical knowledge and improve therapeutic options, ensuring its solutions are backed by robust scientific evidence and real-world efficacy.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Bolesławiec, , Poland
Kraków, , Poland
Ostróda, , Poland
Oświęcim, , Poland
Pabianice, , Poland
Wrocław, , Poland
łódź,, , Poland
świdnica, , Poland
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0
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