RCT Exudate Management Cutimed Sorbion Product Range
ConditionVenous Leg Ulcer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBSN Medical GmbH
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Superabsorbent dressing application
DeviceCutimed Sorbion or Zetuvit plus (RespoSorb) application to maintain wound exudate
Treatment groups
152 Participants
are divided into 2 treatment groupsGroup A: Cutimed Sorbion productsExperimental treatment 1 intervention
Group B: Zetuvit (RespoSorb) productsActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Exudate management performance
Capability to main exudate uptake and retention as well as leakage prevention
Time frame
up to 30 daysSecondary outcomes
1
Dressing change frequency
Number of required intermediate dressing changes between study visits and assessement fo reasons for
Time frame
up to 30 days2
Moisture-associated skin damages
Occurrence of moisture-associated skin damages
Time frame
up to 30 days3
Occurrence clinical relevant peri-wound skin changes
Effect of product use on peri-wound skin such as reddening, swelling, clinical relevant skin detoriations
Time frame
up to 30 days4
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)
Time frame
up to 30 daysSponsors and contacts
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Source ClinicalTrials.gov