RCT Exudate Management Cutimed Sorbion Product Range

NCT06300762 | Recruiting

• 1 other identifier: C3079
• Study Type: interventional
• Target: 152
• Locations: 2 countries
• Sites: 3

Brief 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

Outcome Measures

Primary Outcomes (1)

• Exudate management performance

  Capability to main exudate uptake and retention as well as leakage prevention

  up to 30 days

Secondary Outcomes (8)

• Dressing change frequency

  up to 30 days

• Moisture-associated skin damages

  up to 30 days

• Occurrence clinical relevant peri-wound skin changes

  up to 30 days

• Changes in wound tissue and general wound pain

  up to 30 days

• Need for debridement after product removal

  up to 30 days

Study Arms (2)

Cutimed Sorbion products

EXPERIMENTAL

Within this arm the Cutimed Sorbion (Cutimed® Sorbion® Sachet/Sana/Border) products will be used for exudate managment.

Device: Superabsorbent dressing application

Zetuvit (RespoSorb) products

ACTIVE COMPARATOR

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.

Device: Superabsorbent dressing application

Interventions

Superabsorbent dressing application DEVICE

Cutimed Sorbion or Zetuvit plus (RespoSorb) application to maintain wound exudate

Cutimed Sorbion products; Zetuvit (RespoSorb) products

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant is informed about the trial, understands the nature of the study and provides written informed consent prior to study enrolment
• Participant is mentally and physically able to participate in this study
• Men, women, diverse ≥ 18 years
• Participant complies with study visit schedule
• Participant agrees to comply with all standard therapies (e.g., with regards to compression therapy)
• Participant suffers from lower leg ulcer\* (including the ankle but not the feet) indicated to be treated with the study deviceinvestigational devices, requiring compression and fulfilling the following:
• Ulcer is not younger than 4 weeks and not older than 1 year
• Ulcer is ranging between 2 cm2 and 800 cm2
• One side of the ulcer is not extending 40 cm
• Depth of ulcer \< 2 cm

You may not qualify if:

• Participant already participates in this study with one ulcer (only one ulcer per participant is allowed)
• Participant is expected not to be willing or able to follow the study outlines and requirements
• Participant suffers from systemic infectious disease(s) known to negatively influence wound healing, such as AIDS
• Participant is undergoing an immuno-compromising therapy, such as systemic antineoplastic drugs and/or systemic corticosteroids
• Participant uses any medication that could potentially delay the wound healing ability
• Participant is an employee (staff or student) of the hospital site (institute) or the sponsor or is in a dependent relationship with a member of site or sponsor staff, e.g. child, spouse etc.
• Participant is pregnant or currently breastfeeding
• Participant reporting (and/or suspected by investigator) addiction from alcohol or drugs or is substituted e.g., by Methadone
• \. Participant suffers from alcohol or drug addiction or is substituted e.g., by Methadone 9. Participant is or has been included in another clinical investigation with medical devices or pharmaceutical drugs at present or during the past 30 days 10. Participant with a history of sensitivity to any of the components of the study product 11. Participant whose leg ulcers are clinically infected (e.g., erysipelas) or malignant 12. Study ulcer requiring negative pressure wound therapy or hyperbaric oxygen during the trial 13. The ulcer has exposed bone, tendon, ligaments and/or joint 14. History of radiation at the study ulcer site 15. Participant's lesion is a primary skin cancer 16. Participant's lesion is the manifestation of a metastasis

Sponsors & Collaborators

• BSN Medical GmbH: lead

Study Sites (3)

Niels Stensen Klinik, Christliches-Klinikum-Melle

Melle, Niedersachsten, 49624, Germany

RECRUITING

Mid Yorkshire Teaching NHS Trust Pinderfields Hospital

Wakefield, West Yorkshire, WF1 4DG, United Kingdom

RECRUITING

Northumbria Healthcare NHS Foundation Trust

Ashington, NE63 0HP, United Kingdom

RECRUITING

MeSH Terms

Conditions

Varicose Ulcer

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Hardy Schweigel, PhD

CONTACT

+491522; hardy.schweigel@essity.com

Sandra Tobisch

CONTACT

sandra.tobisch@essity.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Two assessors are blinded to evaluate some outcomes
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2024
• First Posted: March 8, 2024
• Study Start: August 10, 2024
• Primary Completion: November 30, 2025
• Study Completion: December 31, 2025
• Last Updated: January 31, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1); GB (2)