Venous Leg Ulcer (VLU)
Conditions
Brief summary
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.
Interventions
DEVICEMepilex XT
Experimental arm
OTHERstandard care
Sponsors
Molnlycke Health Care AB
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Venous Leg Ulcer 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
1. More than two products of 15 cm x15 cm needed to cover the whole wound and affected peri-wound area 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes From Baseline in Condition of the Peri Wound Skin | 16 weeks | Deteriorationin of skin condition , Mepilex XT and Standard care (%) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Scores on the Visual Analog Scale | 16 weeks | Pain at baseline visit, compared with pain at week 16. VAS scale, minimum pain = 0, maximum pain = 100. |
| Users Feedback After Handling or Use as a Measure of Performance. | 16 weeks | 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. |
| Measure of Actual Dressing Cost and Cost of Care, as Input for Health Economics Calculations. | 16 weeks | — |
Countries
Czechia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard Care standard care ( such as alginate, hydrofiber or other treatment)
standard care | 9 |
| Intervention ( Mepilex XT) Mepilex XT: Experimental arm | 21 |
| Total | 30 |
Baseline characteristics
| Characteristic | Standard Care | Intervention ( Mepilex XT) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 11 Participants | 15 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 10 Participants | 15 Participants |
| Region of Enrollment Czech Republic | 9 participants | 21 participants | 30 participants |
| Sex: Female, Male Female | 5 Participants | 9 Participants | 14 Participants |
| Sex: Female, Male Male | 4 Participants | 12 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 9 | 3 / 21 |
| serious Total, serious adverse events | 0 / 9 | 0 / 21 |
Outcome results
Primary
Changes From Baseline in Condition of the Peri Wound Skin
Deteriorationin of skin condition , Mepilex XT and Standard care (%)
Time frame: 16 weeks
Population: Intention to treat, change from baseline in condition of the peri-wound skin.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intervention ( Mepilex XT) | Changes From Baseline in Condition of the Peri Wound Skin | Redness | 0 percentage of subjects |
| Intervention ( Mepilex XT) | Changes From Baseline in Condition of the Peri Wound Skin | Rash | 5.6 percentage of subjects |
| Intervention ( Mepilex XT) | Changes From Baseline in Condition of the Peri Wound Skin | Maceration | 11.1 percentage of subjects |
| Intervention ( Mepilex XT) | Changes From Baseline in Condition of the Peri Wound Skin | Dermatitis | 0 percentage of subjects |
| Intervention ( Mepilex XT) | Changes From Baseline in Condition of the Peri Wound Skin | Blistering | 0 percentage of subjects |
| Intervention ( Mepilex XT) | Changes From Baseline in Condition of the Peri Wound Skin | skinstripping | 5.6 percentage of subjects |
| Intervention ( Mepilex XT) | Changes From Baseline in Condition of the Peri Wound Skin | Trauma to wound edges | 5.6 percentage of subjects |
| Intervention ( Mepilex XT) | Changes From Baseline in Condition of the Peri Wound Skin | Product degradation | 16.7 percentage of subjects |
| Standard Care | Changes From Baseline in Condition of the Peri Wound Skin | Product degradation | 16.7 percentage of subjects |
| Standard Care | Changes From Baseline in Condition of the Peri Wound Skin | Redness | 0 percentage of subjects |
| Standard Care | Changes From Baseline in Condition of the Peri Wound Skin | Blistering | 0 percentage of subjects |
| Standard Care | Changes From Baseline in Condition of the Peri Wound Skin | Rash | 16.7 percentage of subjects |
| Standard Care | Changes From Baseline in Condition of the Peri Wound Skin | Trauma to wound edges | 0 percentage of subjects |
| Standard Care | Changes From Baseline in Condition of the Peri Wound Skin | Maceration | 16.7 percentage of subjects |
| Standard Care | Changes From Baseline in Condition of the Peri Wound Skin | skinstripping | 0 percentage of subjects |
| Standard Care | Changes From Baseline in Condition of the Peri Wound Skin | Dermatitis | 16.7 percentage of subjects |
Secondary
Measure of Actual Dressing Cost and Cost of Care, as Input for Health Economics Calculations.
Time frame: 16 weeks
Population: the way to collect data differed to much betwen the sites, no analysis could be done.
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention ( Mepilex XT) | Pain Scores on the Visual Analog Scale | Pain at baseline | 17.6 units on a scale (VAS) | Standard Deviation 12.6 |
| Intervention ( Mepilex XT) | Pain Scores on the Visual Analog Scale | Pain at week 16 | 5.8 units on a scale (VAS) | Standard Deviation 14.2 |
| Standard Care | Pain Scores on the Visual Analog Scale | Pain at baseline | 24.0 units on a scale (VAS) | Standard Deviation 22.2 |
| Standard Care | Pain Scores on the Visual Analog Scale | Pain at week 16 | 12.0 units on a scale (VAS) | Standard Deviation 21.7 |
Secondary
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intervention ( Mepilex XT) | Users Feedback After Handling or Use as a Measure of Performance. | Last visit, ease of removal poor | 0 participants |
| Intervention ( Mepilex XT) | Users Feedback After Handling or Use as a Measure of Performance. | Baseline ability to be reposition very poor/poor | 1 participants |
| Intervention ( Mepilex XT) | Users Feedback After Handling or Use as a Measure of Performance. | Last visit, retain exudate good/very good | 17 participants |
| Intervention ( Mepilex XT) | Users Feedback After Handling or Use as a Measure of Performance. | Baseline Ability to retain exudate good/very good | 21 participants |
| Intervention ( Mepilex XT) | Users Feedback After Handling or Use as a Measure of Performance. | Last visit, retain of exudate poor | 0 participants |
| Intervention ( Mepilex XT) | Users Feedback After Handling or Use as a Measure of Performance. | Baseline overall satisfaction good/very good | 21 participants |
| Intervention ( Mepilex XT) | Users Feedback After Handling or Use as a Measure of Performance. | Last visit, adherence to skin good/very good | 17 participants |
| Intervention ( Mepilex XT) | Users Feedback After Handling or Use as a Measure of Performance. | Baseline Adherence to healthy skin poor/very poor | 0 participants |
| Intervention ( Mepilex XT) | Users Feedback After Handling or Use as a Measure of Performance. | Last Visit, adherence to skin poor | 1 participants |
| Intervention ( Mepilex XT) | Users Feedback After Handling or Use as a Measure of Performance. | Baseline overall satisfaction poor/very poor | 0 participants |
| Intervention ( Mepilex XT) | Users Feedback After Handling or Use as a Measure of Performance. | Last Visit, conformability good/very good | 18 participants |
| Intervention ( Mepilex XT) | Users Feedback After Handling or Use as a Measure of Performance. | Baseline Ease of removal poor/very poor | 0 participants |
| Intervention ( Mepilex XT) | Users Feedback After Handling or Use as a Measure of Performance. | Last visit, conformability poor | 0 participants |
| Intervention ( Mepilex XT) | Users Feedback After Handling or Use as a Measure of Performance. | Baseline sticking to woundbed moderate/high | 0 participants |
| Intervention ( Mepilex XT) | Users Feedback After Handling or Use as a Measure of Performance. | Last Visit, ability to be reposition good/very goo | 18 participants |
| Intervention ( Mepilex XT) | Users Feedback After Handling or Use as a Measure of Performance. | Baseline conformability good/very good | 21 participants |
| Intervention ( Mepilex XT) | Users Feedback After Handling or Use as a Measure of Performance. | Last Visit, ability to be reposition poor | 0 participants |
| Intervention ( Mepilex XT) | Users Feedback After Handling or Use as a Measure of Performance. | Baseline sticking to woundbed none/low | 21 participants |
| Intervention ( Mepilex XT) | Users Feedback After Handling or Use as a Measure of Performance. | Last visit, overal satisfaction good/very good | 18 participants |
| Intervention ( Mepilex XT) | Users Feedback After Handling or Use as a Measure of Performance. | Baseline Ability to retain exudate poor | 0 participants |
| Intervention ( Mepilex XT) | Users Feedback After Handling or Use as a Measure of Performance. | Last visit, overal satisfaction poor | 0 participants |
| Intervention ( Mepilex XT) | Users Feedback After Handling or Use as a Measure of Performance. | Baseline pressens of residues wound moderate | 0 participants |
| Intervention ( Mepilex XT) | Users Feedback After Handling or Use as a Measure of Performance. | Last visit, sticking to the wound moderate/low | 4 participants |
| Intervention ( Mepilex XT) | Users Feedback After Handling or Use as a Measure of Performance. | Baseline conformability poor | 0 participants |
| Intervention ( Mepilex XT) | Users Feedback After Handling or Use as a Measure of Performance. | Last visit, sticking to the wound none | 14 participants |
| Intervention ( Mepilex XT) | Users Feedback After Handling or Use as a Measure of Performance. | Baseline pressens of residues wound none/low | 21 participants |
| Intervention ( Mepilex XT) | Users Feedback After Handling or Use as a Measure of Performance. | Last visit, presence of residues wound none/low | 18 participants |
| Intervention ( Mepilex XT) | Users Feedback After Handling or Use as a Measure of Performance. | Baseline Ease of removal good/very good | 5 participants |
| Intervention ( Mepilex XT) | Users Feedback After Handling or Use as a Measure of Performance. | Last visit, presence of residues skin none | 18 participants |
| Intervention ( Mepilex XT) | Users Feedback After Handling or Use as a Measure of Performance. | Baseline pressens of residues skin none/low | 21 participants |
| Intervention ( Mepilex XT) | Users Feedback After Handling or Use as a Measure of Performance. | Last visit, presence of residues skin moderate | 0 participants |
| Intervention ( Mepilex XT) | Users Feedback After Handling or Use as a Measure of Performance. | Baseline ability to be reposition good/very good | 19 participants |
| Intervention ( Mepilex XT) | Users Feedback After Handling or Use as a Measure of Performance. | Last visit, change in periwound condition improved | 14 participants |
| Intervention ( Mepilex XT) | Users Feedback After Handling or Use as a Measure of Performance. | Last visit, ease of removal good/very good | 18 participants |
| Intervention ( Mepilex XT) | Users Feedback After Handling or Use as a Measure of Performance. | Last visit, change in periwound skin unchanged | 3 participants |
| Intervention ( Mepilex XT) | Users Feedback After Handling or Use as a Measure of Performance. | Baseline Adherence to healthy skin good/very good | 21 participants |
| Intervention ( Mepilex XT) | Users Feedback After Handling or Use as a Measure of Performance. | Last visit, change in periwound skin, deteriorated | 1 participants |
| Intervention ( Mepilex XT) | Users Feedback After Handling or Use as a Measure of Performance. | Baseline Ease of application good/very good | 21 participants |
| Standard Care | Users Feedback After Handling or Use as a Measure of Performance. | Last visit, change in periwound skin, deteriorated | 0 participants |
| Standard Care | Users Feedback After Handling or Use as a Measure of Performance. | Baseline Ease of application good/very good | 9 participants |
| Standard Care | Users Feedback After Handling or Use as a Measure of Performance. | Baseline Ease of removal good/very good | 6 participants |
| Standard Care | Users Feedback After Handling or Use as a Measure of Performance. | Baseline Ease of removal poor/very poor | 3 participants |
| Standard Care | Users Feedback After Handling or Use as a Measure of Performance. | Baseline Ability to retain exudate good/very good | 4 participants |
| Standard Care | Users Feedback After Handling or Use as a Measure of Performance. | Baseline Ability to retain exudate poor | 5 participants |
| Standard Care | Users Feedback After Handling or Use as a Measure of Performance. | Baseline Adherence to healthy skin good/very good | 5 participants |
| Standard Care | Users Feedback After Handling or Use as a Measure of Performance. | Baseline Adherence to healthy skin poor/very poor | 4 participants |
| Standard Care | Users Feedback After Handling or Use as a Measure of Performance. | Baseline conformability good/very good | 8 participants |
| Standard Care | Users Feedback After Handling or Use as a Measure of Performance. | Baseline conformability poor | 1 participants |
| Standard Care | Users Feedback After Handling or Use as a Measure of Performance. | Baseline ability to be reposition good/very good | 8 participants |
| Standard Care | Users Feedback After Handling or Use as a Measure of Performance. | Baseline ability to be reposition very poor/poor | 1 participants |
| Standard Care | Users Feedback After Handling or Use as a Measure of Performance. | Baseline overall satisfaction good/very good | 8 participants |
| Standard Care | Users Feedback After Handling or Use as a Measure of Performance. | Baseline overall satisfaction poor/very poor | 1 participants |
| Standard Care | Users Feedback After Handling or Use as a Measure of Performance. | Baseline sticking to woundbed moderate/high | 5 participants |
| Standard Care | Users Feedback After Handling or Use as a Measure of Performance. | Baseline sticking to woundbed none/low | 4 participants |
| Standard Care | Users Feedback After Handling or Use as a Measure of Performance. | Baseline pressens of residues wound moderate | 1 participants |
| Standard Care | Users Feedback After Handling or Use as a Measure of Performance. | Baseline pressens of residues wound none/low | 7 participants |
| Standard Care | Users Feedback After Handling or Use as a Measure of Performance. | Baseline pressens of residues skin none/low | 9 participants |
| Standard Care | Users Feedback After Handling or Use as a Measure of Performance. | Last visit, ease of removal good/very good | 4 participants |
| Standard Care | Users Feedback After Handling or Use as a Measure of Performance. | Last visit, ease of removal poor | 1 participants |
| Standard Care | Users Feedback After Handling or Use as a Measure of Performance. | Last visit, retain exudate good/very good | 1 participants |
| Standard Care | Users Feedback After Handling or Use as a Measure of Performance. | Last visit, retain of exudate poor | 4 participants |
| Standard Care | Users Feedback After Handling or Use as a Measure of Performance. | Last visit, adherence to skin good/very good | 4 participants |
| Standard Care | Users Feedback After Handling or Use as a Measure of Performance. | Last Visit, adherence to skin poor | 1 participants |
| Standard Care | Users Feedback After Handling or Use as a Measure of Performance. | Last Visit, conformability good/very good | 4 participants |
| Standard Care | Users Feedback After Handling or Use as a Measure of Performance. | Last visit, conformability poor | 1 participants |
| Standard Care | Users Feedback After Handling or Use as a Measure of Performance. | Last Visit, ability to be reposition good/very goo | 4 participants |
| Standard Care | Users Feedback After Handling or Use as a Measure of Performance. | Last Visit, ability to be reposition poor | 1 participants |
| Standard Care | Users Feedback After Handling or Use as a Measure of Performance. | Last visit, overal satisfaction good/very good | 4 participants |
| Standard Care | Users Feedback After Handling or Use as a Measure of Performance. | Last visit, overal satisfaction poor | 1 participants |
| Standard Care | Users Feedback After Handling or Use as a Measure of Performance. | Last visit, sticking to the wound moderate/low | 5 participants |
| Standard Care | Users Feedback After Handling or Use as a Measure of Performance. | Last visit, sticking to the wound none | 0 participants |
| Standard Care | Users Feedback After Handling or Use as a Measure of Performance. | Last visit, presence of residues wound none/low | 5 participants |
| Standard Care | Users Feedback After Handling or Use as a Measure of Performance. | Last visit, presence of residues skin none | 4 participants |
| Standard Care | Users Feedback After Handling or Use as a Measure of Performance. | Last visit, presence of residues skin moderate | 1 participants |
| Standard Care | Users Feedback After Handling or Use as a Measure of Performance. | Last visit, change in periwound condition improved | 5 participants |
| Standard Care | Users Feedback After Handling or Use as a Measure of Performance. | Last visit, change in periwound skin unchanged | 1 participants |