Mepilex Border Flex Utilization Pilot Spain

NCT ID: NCT06321978

Last Updated: 2024-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-16

Study Completion Date

2024-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Wound

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

OTHER

Study Groups

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Study Group

Mepilex Border Flex dressing changes

Mepilex Border Flex

Intervention Type DEVICE

Usage of Mepilex Border Flex according to intended use and standard of care.

Interventions

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Mepilex Border Flex

Usage of Mepilex Border Flex according to intended use and standard of care.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Molnlycke Health Care AB

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CS Ciudad Expo - Mairena de Aljarafe

Seville, Andalusia, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Fia Navntoft

Role: CONTACT

+46 31-722 30 00

Facility Contacts

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Andrés Roldán Valenzuela, Nurse

Role: primary

+34609431073

Other Identifiers

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MxBFlexUP ESP

Identifier Type: -

Identifier Source: org_study_id

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