RCT Exudate Management Cutimed Sorbion Product Range

Venous Leg Ulcer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06300762
• Other study ID #: C3079
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: June 30, 2025

Study information

• Verified date: February 2024
• Source: BSN Medical GmbH
• Contact: Hardy Schweigel, PhD
• Phone: +491522
• Email: hardy.schweigel[@]essity.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 152
• Est. completion date: June 30, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Leg Ulcer
• Varicose Ulcer
• Venous Leg Ulcer

Intervention

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

Locations

Country	Name	City	State
Germany	Niels Stensen Klinik, Christliches-Klinikum-Melle	Melle	Niedersachsten

Sponsors (1)

Lead Sponsor	Collaborator
BSN Medical GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exudate management performance	Capability to main exudate uptake and retention as well as leakage prevention	up to 30 days
Secondary	Dressing change frequency	Number of required intermediate dressing changes between study visits and assessement fo reasons for	up to 30 days
Secondary	Moisture-associated skin damages	Occurrence of moisture-associated skin damages	up to 30 days
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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