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

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.

Study Overview

• Status: Recruiting
• Conditions: Venous Leg Ulcer
• Intervention / Treatment: Device: Superabsorbent dressing application

• Study Type: Interventional
• Enrollment (Estimated): 152
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hardy Schweigel, PhD; Phone Number: 7752954 +491522; Email: hardy.schweigel@essity.com
• Study Contact Backup: Name: Sandra Tobisch; Email: sandra.tobisch@essity.com

Study Locations

• Germany
  • Niedersachsten
    • Melle, Niedersachsten, Germany, 49624
      • Recruiting
      • Niels Stensen Klinik, Christliches-Klinikum-Melle
      • Contact: Jan Heggemann
      • Contact: Sabine Guth
• United Kingdom
  • Ashington, United Kingdom, NE63 0HP
    • Recruiting
    • Northumbria Healthcare NHS Foundation Trust
    • Contact: Debera Drew; Phone Number: 800-555-5555; Email: nn@nn.dd
  • West Yorkshire
    • Wakefield, West Yorkshire, United Kingdom, WF1 4DG
      • Recruiting
      • Mid Yorkshire Teaching NHS Trust Pinderfields Hospital
      • Contact: Martin Sylvester; Phone Number: 800-555-5555; Email: nn@nn.nn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Participant is informed about the trial, understands the nature of the study and provides written informed consent prior to study enrolment
2. Participant is mentally and physically able to participate in this study
3. Men, women, diverse ≥ 18 years
4. Participant complies with study visit schedule
5. Participant agrees to comply with all standard therapies (e.g., with regards to compression therapy)
6. 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:
7. Ulcer is not younger than 4 weeks and not older than 1 year
8. Ulcer is ranging between 2 cm2 and 800 cm2
9. One side of the ulcer is not extending 40 cm
10. Depth of ulcer < 2 cm
11. Ankle-brachial pressure index (ABPI) of >0.8 and ≤1.3, measurement not older than 12 months * Participants with more than one ulcer are eligible for inclusion, however only one ulcer per patient will be included in the study.

Exclusion Criteria:

1. Participant already participates in this study with one ulcer (only one ulcer per participant is allowed)
2. Participant is expected not to be willing or able to follow the study outlines and requirements
3. Participant suffers from systemic infectious disease(s) known to negatively influence wound healing, such as AIDS
4. Participant is undergoing an immuno-compromising therapy, such as systemic antineoplastic drugs and/or systemic corticosteroids
5. Participant uses any medication that could potentially delay the wound healing ability
6. 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.
7. Participant is pregnant or currently breastfeeding
8. Participant reporting (and/or suspected by investigator) addiction from alcohol or drugs or is substituted e.g., by Methadone

8. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cutimed Sorbion products; Within this arm the Cutimed Sorbion (Cutimed® Sorbion® Sachet/Sana/Border) products will be used for exudate managment.	Device: Superabsorbent dressing application; Cutimed Sorbion or Zetuvit plus (RespoSorb) application to maintain wound exudate
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.	Device: Superabsorbent dressing application; Cutimed Sorbion or Zetuvit plus (RespoSorb) application to maintain wound exudate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exudate management performance	Capability to main exudate uptake and retention as well as leakage prevention	up to 30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dressing change frequency	Number of required intermediate dressing changes between study visits and assessement fo reasons for	up to 30 days
Moisture-associated skin damages	Occurrence of moisture-associated skin damages	up to 30 days
Occurrence clinical relevant peri-wound skin changes	Effect of product use on peri-wound skin such as reddening, swelling, clinical relevant skin detoriations	up to 30 days
Changes in wound tissue and general wound pain	Effect of product use on the wound considering wound tissue and slough on the wound as well as the general wound pain assessed using a 11 visual analogue scale from 0-10 (0= not pain, 10=most imaginable pain for the participant)	up to 30 days
Need for debridement after product removal	Evaluation of the soft debridement effect of Cutimed Sorbion products during dressing removal: is the soft debrimdent supporting wound cleansing and eases addtional wound debridement	up to 30 days
Patient satisfaction with treatment and product	Patient´s impressions about treatment and felt protection for leakage when using the product and assessment of individually felt wearing comfort	final study visit
HCP satisfaction with treatment and product	HCP´s satisfaction with treatment and product performance to manage wound exudate, check if treatment need have been met be the product	final study visit
Changes in quality of life using the "Wound-QoL 14" (short questionnaire measuring quality of life in patients with chronic wounds based on three established disease-specific instruments)	Fourteen items are scored using a Likert-type scale as either 'not at all', 'a little', 'moderately', 'quite a lot' or 'very much'. Item data are calculated building a global score and the 3 subscores "Body", "Psyche/Well-being" and the "Everyday life". In increase in quality of life is indicated by decreasing sub- and/or global score.	day 0 and day 30

Collaborators and Investigators

• Sponsor: BSN Medical GmbH

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2024
• Primary Completion (Estimated): November 30, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: February 20, 2024
• First Submitted That Met QC Criteria: March 7, 2024
• First Posted (Actual): March 8, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 29, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Skin Diseases; Skin Ulcer; Varicose Veins; Varicose Ulcer; Leg Ulcer
• Other Study ID Numbers: C3079

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No