Mepilex Border Flex Utilization Pilot Spain (MxBFlexUPESP)

Molnlycke Health Care

Status: Enrolling

Conditions: Wound

Treatments: Device: Mepilex Border Flex

Study type: Observational

Funder types: Industry

Identifiers

NCT06321978

MxBFlexUP ESP

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

40 participants in 1 patient group

Study Group

Description:

Mepilex Border Flex dressing changes

Treatment:

Device: Mepilex Border Flex