RCT Exudate Management Cutimed Sorbion Product Range

Sponsor
BSN Medical GmbH
Study ID
NCT06300762
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Superabsorbent dressing application — DEVICE
    Cutimed Sorbion or Zetuvit plus (RespoSorb) application to maintain wound exudate

Study Details

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.

Key Dates

First listed
Mar 8, 2024
Start date
Aug 10, 2024
Status verified
Jan 2025
Primary completion
Nov 30, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
152 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cutimed Sorbion products
    Within this arm the Cutimed Sorbion (Cutimed® Sorbion® Sachet/Sana/Border) products will be used for exudate managment.
  • Active Comparator: Zetuvit (RespoSorb) products
    Within this arm the comperator products Zetuvit® Plus/(RespoSorb® Super), Zetuvit® Plus Silicone/(RespoSorb® Silicone) and Zetuvit® Plus Silicone Border/(RespoSorb® Silicone Border) will be used for exudate management.

Primary Outcome Measure

Exudate management performance [ Time Frame: up to 30 days ]

Central Contacts

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