Actively Recruiting
RCT Exudate Management Cutimed Sorbion Product Range
Led by BSN Medical GmbH · Updated on 2025-01-31
152
Participants Needed
3
Research Sites
72 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
RCT Exudate Management Cutimed Sorbion Product Range
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant is informed about the trial, understands the study, and provides written consent before enrollment
- Participant is mentally and physically able to participate
- Men, women, and diverse participants aged 18 years or older
- Participant agrees to comply with study visits and standard therapies such as compression therapy
- Participant has a lower leg or ankle ulcer (but not foot ulcer) suitable for treatment with the study device
- Ulcer is between 4 weeks and 1 year old
- Ulcer size ranges from 2 cm² to 800 cm²
- Ulcer length on one side does not exceed 40 cm
- Ulcer depth is less than 2 cm
- Ankle-brachial pressure index (ABPI) is greater than 0.8 and less than or equal to 1.3, measured within the past 12 months
- If multiple ulcers exist, only one ulcer will be included in the study
You will not qualify if you...
- Participant already enrolled with one ulcer (only one ulcer per participant allowed)
- Participant unlikely to follow study requirements
- Participant has systemic infectious diseases affecting wound healing such as AIDS
- Participant is undergoing immunosuppressive therapy like systemic cancer drugs or corticosteroids
- Participant uses medication that may delay wound healing
- Participant is an employee or student of the hospital or sponsor or has a dependent relationship with staff
- Participant is pregnant or breastfeeding
- Participant has or is suspected of alcohol or drug addiction or is on substitution therapy like Methadone
- Participant enrolled in another clinical trial with medical devices or drugs currently or in the past 30 days
- Participant has history of sensitivity to components of the study product
- Ulcer is clinically infected or malignant
- Ulcer requires negative pressure wound therapy or hyperbaric oxygen during the trial
- Ulcer exposes bone, tendon, ligaments, or joint
- History of radiation at the ulcer site
- Ulcer is a primary skin cancer or metastasis manifestation
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Niels Stensen Klinik, Christliches-Klinikum-Melle
Melle, Niedersachsten, Germany, 49624
Actively Recruiting
2
Mid Yorkshire Teaching NHS Trust Pinderfields Hospital
Wakefield, West Yorkshire, United Kingdom, WF1 4DG
Actively Recruiting
3
Northumbria Healthcare NHS Foundation Trust
Ashington, United Kingdom, NE63 0HP
Actively Recruiting
Research Team
H
Hardy Schweigel, PhD
CONTACT
S
Sandra Tobisch
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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