WoundMxBFlexUPESPNCT06321978
Mepilex Border Flex Utilization Pilot Spain
An observational study of Wound, run by Molnlycke Health Care AB at 1 site in Spain.
Trial summary
The aim of this study is to assess and describe the utilization of Mepilex® Border Flex and other foam dressings available in routine clinical practice in the management of patients with chronic wounds, in order to understand the pattern of use and the frequency of dressing changes in wound management. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wound
- What is being tested?
- Mepilex Border Flex
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 16 Feb 2024to 31 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study is addressed to adult patients with chronic wounds- wounds that have not reduced in size by more than 40% to 50% or healed within a month, and who are already being treated with a foam dressing. The patient must be deemed by HPC to be treated with Mepilex® Border Flex according to the indications of the dressing.
Who may be able to join
- Patients aged 18 years or older.
- The patient has been deemed by the HCP to change dressing to Mepilex® Border Flex.
- Patients with chronic wounds (wounds that have not reduced in size by more than 40% to 50% or healed within a month) treated with foam dressings, other that Mepilex® Border Flex, according to its intended use at baseline visit for minimum 4 weeks.
- Patients with an expectation of wound follow-up of at least 4 weeks.
- Patients agree only to have the dressing changed by the HCP.
- Patients capable of signing the Informed Consent Form and answer the questions being asked.
Who cannot join
- Patients with any applicable contraindication or sensibilization to any of the dressing compounds
- Patients with pressure ulcers (PU) stage I, deep tissue injuries or terminal wounds (e.g., fungating wounds)
- Patients with wounds whose location and/or aetiology requires a dressing change for reasons that are unrelated to the dressing characteristics such as wounds in the sacral area.
- Hospice patients
- Patients participating in other studies interfering with this study.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
CS Ciudad Expo - Mairena de Aljarafe
Seville, Andalusia, 41927
Andrés Roldán Valenzuela, Nurse, +34609431073, andres.roldan.sspa@juntadeandalucia.es
Andrés Roldán Valenzuela, Nurse
About this study
Official title: Observational Study to Describe the Utilization of Foam Dressings in Routine Clinical Practice, for the Treatment of Patients With Chronic Wounds in Primary Healthcare Centers in Spain.
The aim of this study is to assess and describe the utilization of Mepilex® Border Flex and other foam dressings available in routine clinical practice in the management of patients with chronic wounds, in order to understand the pattern of use and the frequency of dressing changes in wound management. The study will also allow to gain information about the opinion of the HCPs and the patient's experience concerning wound management with foam dressings. This information may help to understand patient's health care optimization in terms of quality and efficiency.
- Conditions
- Wound
- Being tested
- Mepilex Border Flex
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mepilex Border FlexDevice
Usage of Mepilex Border Flex according to intended use and standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Mepilex Border Flex dressing changes Receives: Device: Mepilex Border Flex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dressing use
Number of dressings used the week before baseline visit compared to the number of dressings used the week before follow-up visit.
Measured: 4 weeks
Secondary outcomes (5)
Wound characteristics
Describe clinical characteristics of chronic wounds that are treated with foam dressings in routine clinical practice by HCP assessment
Measured: 4 weeks
Wound management
Describe the management of chronic wounds in terms of frequency of dressing change, type of dressings used and reason for dressing change
Measured: 4 weeks
Technical Performance (HCP evaluation)
Several questions will be asked to evaluate the technical performance properties of the primary dressing. The following will be assessed by the investigator/designee using no/yes values:
- Based on this patient, would you recommend Mepilex Border Flex for use in your organisation?
All other properties will be assessed by the investigator/designee using a 3-item scale of worse, same, better. These include:
- Ease of application
- Ease of removal
- Ability to conform to wound site
- Ability to indicate the need for dressing change
- Ability to stay in place
- Trauma to the wound bed
- Ability to indicate the need for dressing change
- Trauma to the wound bed
- Trauma to the peri-wound skin
- Patient concordance
- Overall dressing performance
Measured: 4 weeks
Patient Experience (PRO)
Patients are asked to rate the dressings in regards their experience
The following questions will be assessed by the investigator/designee using a 1-10 level visual analogue scale for pain:
- How wound you rate the pain in your wound today?
- How would you rate the pain when Mepilex Border Flex was removed from your wound today?
The following will be assessed by the investigator/designee using no/yes values:
*Would you recommend this treatment to a relative or friend?
All other properties will be assessed by the investigator/designee using a 4-item scale of very poor, poor, good, very good. These include:
- How would you rate the comfort of Mepilex Border Flex applied to your wound?
- How would you rate Mepilex Border Flex used in regards to the ability to stay in place?
- How would you rate your overall satisfaction regarding wound management (including the properties of Mepilex Border Flex and treatment of your wound)
Measured: 4 weeks
Costs
Estimate the weekly cost per patient associated with the dressings used in wound care episodes and the characteristics of use by evaluating type and size of wound and frequency of dressing change
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start16 Feb 2024
- Primary completion31 May 2024 (estimated)
- Study completion31 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WoundStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Molnlycke Health Care AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06321978
- Sponsor's protocol ID
- MxBFlexUP ESP
- Acronym
- MxBFlexUPESP
- Status last verified
- May 2024
- First submitted
- 29 Feb 2024
- Last updated
- 23 May 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study to Describe the Utilization of Foam Dressings in Routine Clinical Practice, for the Treatment of Patients With Chronic Wounds in Primary Healthcare Centers in Spain.
- ClinicalTrials.gov ID
- NCT06321978
- Acronym / sponsor ID
- MxBFlexUPESP / MxBFlexUP ESP
- Conditions
- Wound
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Molnlycke Health Care ABIndustry (pharma, biotech, devices)
- Study start
- 16 Feb 2024 (actual)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 31 May 2024 (estimated)
- First posted
- 20 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to assess and describe the utilization of Mepilex® Border Flex and other foam dressings available in routine clinical practice in the management of patients with chronic wounds, in order to understand the pattern of use and the frequency of dressing changes in wound management. The study will also allow to gain information about the opinion of the HCPs and the patient's experience concerning wound management with foam dressings. This information may help to understand patient's health care optimization in terms of quality and efficiency.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | Device: Mepilex Border FlexMepilex Border Flex dressing changes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study is addressed to adult patients with chronic wounds- wounds that have not reduced in size by more than 40% to 50% or healed within a month, and who are already being treated with a foam dressing. The patient must be deemed by HPC to be treated with Mepilex® Border Flex according to the indications of the dressing.
Key inclusion criteria (6 listed)
- Patients aged 18 years or older.
- The patient has been deemed by the HCP to change dressing to Mepilex® Border Flex.
- Patients with chronic wounds (wounds that have not reduced in size by more than 40% to 50% or healed within a month) treated with foam dressings, other that Mepilex® Border Flex, according to its intended use at baseline visit for minimum 4 weeks.
- Patients with an expectation of wound follow-up of at least 4 weeks.
- Patients agree only to have the dressing changed by the HCP.
Key exclusion criteria (5 listed)
- Patients with any applicable contraindication or sensibilization to any of the dressing compounds
- Patients with pressure ulcers (PU) stage I, deep tissue injuries or terminal wounds (e.g., fungating wounds)
- Patients with wounds whose location and/or aetiology requires a dressing change for reasons that are unrelated to the dressing characteristics such as wounds in the sacral area.
- Hospice patients
- Patients participating in other studies interfering with this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mepilex Border FlexUsage of Mepilex Border Flex according to intended use and standard of care. | Device | Study Group |
Primary outcome
Dressing use
Time frame: 4 weeks
Number of dressings used the week before baseline visit compared to the number of dressings used the week before follow-up visit.
5 secondary outcomes
Wound characteristics
Time frame: 4 weeks
Wound management
Time frame: 4 weeks
Technical Performance (HCP evaluation)
Time frame: 4 weeks
Patient Experience (PRO)
Time frame: 4 weeks
Costs
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wound, run by Molnlycke Health Care AB at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fia Navntoft (+46 31-722 30 00, fia.navntoft@molnlycke.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dressing use (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2024.