Clinical trial NCT06300762: RCT Exudate Management Cutimed Sorbion Product Range
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Venous Leg Ulcer
Lead sponsor: BSN Medical GmbH
Sponsor class: INDUSTRY
First posted: 2024-03-08
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Exudate management performance
timeFrame: up to 30 days
Secondary outcomes:
measure: Dressing change frequency
timeFrame: up to 30 days
measure: Moisture-associated skin damages
timeFrame: up to 30 days
measure: Occurrence clinical relevant peri-wound skin changes
timeFrame: up to 30 days
measure: Changes in wound tissue and general wound pain
timeFrame: up to 30 days
measure: Need for debridement after product removal
timeFrame: up to 30 days
measure: Patient satisfaction with treatment and product
timeFrame: final study visit
measure: HCP satisfaction with treatment and product
timeFrame: final study visit
measure: 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)
timeFrame: day 0 and day 30
Other outcomes:
Locations:
city: Melle
country: Germany
facility: Niels Stensen Klinik, Christliches-Klinikum-Melle
state: Niedersachsten
city: Wakefield
country: United Kingdom
facility: Mid Yorkshire Teaching NHS Trust Pinderfields Hospital
state: West Yorkshire
city: Ashington
country: United Kingdom
facility: Northumbria Healthcare NHS Foundation Trust
Study officials:
References: