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Search / Trial NCT05646121

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 February 05, 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.

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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