NCT06300762

RCT Exudate Management Cutimed Sorbion Product Range

A Prospective, Multicenter, Partially Assessor Blinded, Randomised, Open Label, Parallel, Comparative Clinical Trial to Evaluate the Exudate Management Performance of Cutimed Sorbion Product Range

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 152 (estimated)
• Sponsor: BSN Medical GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The fluid handling capacity of superabsorbent dressings varies depending on the design and construction. The use of effective advanced wound dressings is a promising strategy to achieve adequate absorption of wound exudate and malodour promoting wound healing. The aim of the current study is to determine whether there is a difference in the clinical performance of exudate absorption with two commonly used CE-marked superabsorbent dressings when used on VLUs in routine wound care. As primary objective the dressing´s absorption performance and its ability to prevent skin maceration and leakage of the wound dressing will be investigated.

Conditions

• Venous Leg Ulcer

Interventions

Type	Name	Description
DEVICE	Superabsorbent dressing application	Cutimed Sorbion or Zetuvit plus (RespoSorb) application to maintain wound exudate

Timeline

• Start date: 2024-08-10
• Primary completion: 2025-11-30
• Completion: 2025-12-31
• First posted: 2024-03-08
• Last updated: 2025-01-31

Locations

3 sites across 2 countries: Germany, United Kingdom