An interventional study of Mepilex XT and standard care in Venous Leg Ulcer (VLU), sponsored by Molnlycke Health Care AB. Completed at 3 sites in Czech Republic. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-10-26.
Sponsored by Molnlycke Health Care AB · Not applicable, Interventional, and Treatment
This investigation is a Post Marketing Follow-Up Study for Mepilex XT conducted as part of Mölnlycke Health Care's quality system. The primary objective is to evaluate the performance of the dressing when used as intended on exuding Venous Leg Ulcers (VLUs) in the inflammatory and granulating stages of the wound healing process.
378 studies on the registry are indexed under Varicose Ulcer; 80 are open to participants now.
This study's enrollment of 30 is below the median of 64 across 325 interventional studies indexed under Varicose Ulcer.
Browse Varicose Ulcer studies →Molnlycke Health Care AB is the lead sponsor of 58 studies on the registry; 7 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 3 (38%) have results posted.
Counted across the registry records on this site, refreshed daily.
Signed Informed Consent
Exclusion Criteria:
standard care ( such as alginate, hydrofiber or other treatment)
Other: standard care
Device: Mepilex XT
Experimental arm
Changes From Baseline in Condition of the Peri Wound Skin
Deteriorationin of skin condition , Mepilex XT and Standard care (%)
Time frame: 16 weeks
Pain Scores on the Visual Analog Scale
Pain at baseline visit, compared with pain at week 16. VAS scale, minimum pain = 0, maximum pain = 100.
Time frame: 16 weeks
Users Feedback After Handling or Use as a Measure of Performance.
Investigator/Nurse and Subject evaluation of performance of the primary dressing ( n) Scale= Good , Very Good, Poor, Very Poor 1Ease of application, 2 Ease of removal, 3 Ability to retain exudate, 4 Adherence to healthy skin, 5 Confomability to be repositioned , 6 Overall satisfaction, 7 Dressing sticking to wound bed, 8 Presence of residues on the wound bed. 9 Presence of residues on the healthy skin. 10 Overall evaluation of change in periwound skin condition.
Time frame: 16 weeks
Measure of Actual Dressing Cost and Cost of Care, as Input for Health Economics Calculations.
Time frame: 16 weeks
| Milestone | Standard Care | Intervention ( Mepilex XT) |
|---|---|---|
| Started | 9 | 21 |
| Completed | 9 | 21 |
| Not completed | 0 | 0 |
Deteriorationin of skin condition , Mepilex XT and Standard care (%)
| percentage of subjects | Intervention ( Mepilex XT) | Standard Care |
|---|---|---|
| Redness | 0 | 0 |
| Rash | 5.6 | 16.7 |
| Maceration | 11.1 | 16.7 |
| Dermatitis | 0 | 16.7 |
| Blistering | 0 | 0 |
| skinstripping | 5.6 | 0 |
| Trauma to wound edges | 5.6 | 0 |
| Product degradation | 16.7 | 16.7 |
Pain at baseline visit, compared with pain at week 16. VAS scale, minimum pain = 0, maximum pain = 100.
| units on a scale (VAS) | Intervention ( Mepilex XT) | Standard Care |
|---|---|---|
| Pain at baseline | 17.6 ± 12.6 | 24.0 ± 22.2 |
| Pain at week 16 | 5.8 ± 14.2 | 12.0 ± 21.7 |
Investigator/Nurse and Subject evaluation of performance of the primary dressing ( n) Scale= Good , Very Good, Poor, Very Poor 1Ease of application, 2 Ease of removal, 3 Ability to retain exudate, 4 Adherence to healthy skin, 5 Confomability to be repositioned , 6 Overall satisfaction, 7 Dressing sticking to wound bed, 8 Presence of residues on the wound bed. 9 Presence of residues on the healthy skin. 10 Overall evaluation of change in periwound skin condition.
| participants | Intervention ( Mepilex XT) | Standard Care |
|---|---|---|
| Baseline Ease of application good/very good | 21 | 9 |
| Baseline Ease of removal good/very good | 5 | 6 |
| Baseline Ease of removal poor/very poor | 0 | 3 |
| Baseline Ability to retain exudate good/very good | 21 | 4 |
| Baseline Ability to retain exudate poor | 0 | 5 |
| Baseline Adherence to healthy skin good/very good | 21 | 5 |
| Baseline Adherence to healthy skin poor/very poor | 0 | 4 |
| Baseline conformability good/very good | 21 | 8 |
| Baseline conformability poor | 0 | 1 |
| Baseline ability to be reposition good/very good | 19 | 8 |
| Baseline ability to be reposition very poor/poor | 1 | 1 |
| Baseline overall satisfaction good/very good | 21 | 8 |
| Baseline overall satisfaction poor/very poor | 0 | 1 |
| Baseline sticking to woundbed moderate/high | 0 | 5 |
| Baseline sticking to woundbed none/low | 21 | 4 |
| Baseline pressens of residues wound moderate | 0 | 1 |
| Baseline pressens of residues wound none/low | 21 | 7 |
| Baseline pressens of residues skin none/low | 21 | 9 |
| Last visit, ease of removal good/very good | 18 | 4 |
| Last visit, ease of removal poor | 0 | 1 |
| Last visit, retain exudate good/very good | 17 | 1 |
| Last visit, retain of exudate poor | 0 | 4 |
| Last visit, adherence to skin good/very good | 17 | 4 |
| Last Visit, adherence to skin poor | 1 | 1 |
| Last Visit, conformability good/very good | 18 | 4 |
| Last visit, conformability poor | 0 | 1 |
| Last Visit, ability to be reposition good/very goo | 18 | 4 |
| Last Visit, ability to be reposition poor | 0 | 1 |
| Last visit, overal satisfaction good/very good | 18 | 4 |
| Last visit, overal satisfaction poor | 0 | 1 |
| Last visit, sticking to the wound moderate/low | 4 | 5 |
| Last visit, sticking to the wound none | 14 | 0 |
| Last visit, presence of residues wound none/low | 18 | 5 |
| Last visit, presence of residues skin none | 18 | 4 |
| Last visit, presence of residues skin moderate | 0 | 1 |
| Last visit, change in periwound condition improved | 14 | 5 |
| Last visit, change in periwound skin unchanged | 3 | 1 |
| Last visit, change in periwound skin, deteriorated | 1 | 0 |
No measurements were reported for this outcome.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Standard Care | — | 0/9 (0%) | 0/9 (0%) |
| Intervention ( Mepilex XT) | — | 0/21 (0%) | 3/21 (14.3%) |
| Event | Standard Care | Intervention ( Mepilex XT) |
|---|---|---|
| Low pain in the skin under dressingSkin and subcutaneous tissue disorders | 0/9 | 2/21 |
| wound infectionSkin and subcutaneous tissue disorders | 0/9 | 1/21 |
All subjects that have used at least one product and that have some follow-up data for the primary endpoint is included in the population presented.
| Age, Categorical(Participants) | Standard Care | Intervention ( Mepilex XT) | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 5 | 10 | 15 |
| >=65 years | 4 | 11 | 15 |
| Sex: Female, Male(Participants) | Standard Care | Intervention ( Mepilex XT) | Total |
|---|---|---|---|
| Female | 5 | 9 | 14 |
| Male | 4 | 12 | 16 |
| Region of Enrollment(participants) | Standard Care | Intervention ( Mepilex XT) | Total |
|---|---|---|---|
| Czech Republic | 9 | 21 | 30 |
This study is completed, as verified in May 2014. You cannot join it, but the record below documents what was studied.
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Molnlycke Health Care AB