A Multicenter, Post Marketing Clinical Follow up (PMCF) Investigation to Evaluate the Performance and Safety of a Soft Silicone Foam Dressing and to Evaluate the Performance of Standard Care in Exuding Venous Leg Ulcers
NCT ID: NCT02167815
Last Updated: 2016-10-26
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2014-05-31
2015-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standard care
standard care ( such as alginate, hydrofiber or other treatment)
standard care
Intervention ( Mepilex XT)
Mepilex XT
Experimental arm
Interventions
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Mepilex XT
Experimental arm
standard care
Eligibility Criteria
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Inclusion Criteria
2. Exuding wound
3. Wound surface covered with sloughy tissue\* (before debridement)
4. Wound size ≥ 6 cm2
5. In case of multiple wounds, target wound must be ≥ 3cm distant from other wounds.
6. Wound suitable for treatment with the relevant primary dressing\*\*
7. Male or female, 18 years of age and above
8. Signed Informed Consent
* Sloughy tissue defined as wet, yellow-brown fibrinous tissue present in the wound bed \*\* Mepilex XT in the intervention group. Standard care in the observation group
Exclusion Criteria
2. Wound cavity and/or fistula
3. Full thickness burns
4. Exposed tendons and/or fascia
5. Bleeding wounds
6. Malignant or fungating wounds
7. Wound age \> 12 months
8. Use of antimicrobial dressings or topical agents such as antiseptics, local antibiotics and steroids within 7 days from inclusion on the wound intended to be included
9. Untreated limb ischemia (according to investigator's judgement) at the time of inclusion
10. Subject not suitable for the investigation according to the investigator's judgement
11. Subject included in other ongoing clinical investigation which could interfere with this investigation, as judged by the investigator
12. Known allergy/hypersensitivity to any of the components of the primary dressing
18 Years
ALL
No
Sponsors
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Molnlycke Health Care AB
INDUSTRY
Responsible Party
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Locations
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Nemocnice Podlesí a.s.
Třinec, Konská 453, Czechia
Nemocnice Jihlava
Jihlava, Vrchlického, Czechia
The General University Hospital in Prague
Prague, , Czechia
Countries
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Other Identifiers
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RedEgg 01
Identifier Type: -
Identifier Source: org_study_id