NCT05646121

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

Post-market Clinical Follow-up Study to Evaluate the Performance and Safety of Suprasorb® A + Ag Wound Dressing and Rope in the Treatment of Wounds at Risk of Infection and Infected Wounds

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 99 (actual)
• Sponsor: Lohmann & Rauscher · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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 clinical examination and wound area measurements.

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-09-13
• Primary completion: 2023-12-05
• Completion: 2023-12-05
• First posted: 2022-12-12
• Last updated: 2024-01-26

Locations

8 sites across 1 country: Poland