Assessing the use of Mepilex Border Flex for chronic wound management
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.
This study is testing how well Mepilex Border Flex and other foam dressings work for managing chronic wounds in everyday healthcare settings.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Molnlycke Health Care AB Industry-sponsored |
| Locations | 1 site (Seville, Andalusia) |
| Trial ID | NCT06321978 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate how Mepilex® Border Flex and other foam dressings are utilized in the management of chronic wounds in routine clinical practice. It will gather data on the frequency of dressing changes and the experiences of healthcare professionals and patients regarding wound management. By understanding these patterns, the study seeks to optimize healthcare delivery in terms of quality and efficiency for patients with chronic wounds.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with chronic wounds who are transitioning to Mepilex® Border Flex dressing.
Not a fit: Patients with pressure ulcers, terminal wounds, or those requiring unrelated dressing changes may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance wound care practices and improve patient outcomes in chronic wound management.
How similar studies have performed: While this study focuses on a specific product, similar studies assessing foam dressings have shown positive outcomes in wound management.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Seville, Andalusia
- CS Ciudad Expo - Mairena de Aljarafe — Seville, Andalusia, Spain (Recruiting)
Study contacts
- Study coordinator: Fia Navntoft
- Email: fia.navntoft@molnlycke.com
- Phone: +46 31-722 30 00
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.