Mepilex Border Flex Utilization Pilot Spain

Launched by MOLNLYCKE HEALTH CARE AB · Mar 13, 2024

Keywords

ClinConnect Summary

This clinical trial, called the Mepilex Border Flex Utilization Pilot in Spain, is designed to study how effective a specific type of dressing, called Mepilex® Border Flex, is for managing chronic wounds. Chronic wounds are those that do not heal well over time. The trial aims to understand how often these dressings are used, how frequently they need to be changed, and gather opinions from healthcare providers and patients about their experiences with this type of wound care. This information can help improve the quality and efficiency of wound management for patients.

To participate in this study, you need to be at least 18 years old and have a chronic wound that has not improved significantly over the past month. Your healthcare provider should also recommend switching your dressing to Mepilex® Border Flex. Participants will need to agree to have their dressings changed only by a healthcare professional and must be able to provide informed consent. It’s important to note that certain patients, such as those with specific types of wounds or in hospice care, will not be eligible for this trial. If you qualify, you can expect regular follow-ups regarding your wound care for at least four weeks.

Gender

ALL

Eligibility criteria

• 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.