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

NCT05646121 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 99

Last updated 2024-01-26

No results posted yet for this study

Summary

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.

Conditions

  • Pressure Ulcer
  • Arterial Ulcers
  • Venous Leg Ulcer
  • Diabetic Ulcers
  • Surgical Wound
  • Skin Graft

Interventions

DEVICE

Suprasorb® A + Ag wound dressing and rope

Suprasorb® A + Ag Antimicrobial Calcium Alginate Wound Dressings / Packing Rope are soft, conformable wound coverings with a high mannuronic acid content (mass per unit area ≥100 g/m2). The silver impregnated calcium alginate fibres react with wound exudate or blood to form a gel which creates a moist wound environment. The silver contained in the wound dressing has broad antimicrobial activity, including against MRSA and VRE. Antimicrobial action (\>3 log steps) associated with the ionic silver from the silver alginate fibres (1.5%) is observed in vitro after just 24 h and this remains stable for up to seven days

Sponsors & Collaborators

  • Lohmann & Rauscher

    lead INDUSTRY

Principal Investigators

  • Claudia Feldkamp, Dr. · Lohmann & Rauscher

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-13
Primary Completion
2023-12-05
Completion
2023-12-05

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05646121 on ClinicalTrials.gov