Mepilex Border Flex Utilization Pilot Spain

NCT06321978 | Recruiting

• 1 other identifier: MxBFlexUP ESP
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• Dressing use

  Number of dressings used the week before baseline visit compared to the number of dressings used the week before follow-up visit.

  4 weeks

Secondary Outcomes (5)

• Wound characteristics

  4 weeks

• Wound management

  4 weeks

• Technical Performance (HCP evaluation)

  4 weeks

• Patient Experience (PRO)

  4 weeks

• Costs

  4 weeks

Study Arms (1)

Study Group

Mepilex Border Flex dressing changes

Device: Mepilex Border Flex

Interventions

Mepilex Border Flex DEVICE

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

Study Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Molnlycke Health Care AB: lead

Study Sites (1)

CS Ciudad Expo - Mairena de Aljarafe

Seville, Andalusia, 41927, Spain

RECRUITING

MeSH Terms

Conditions

Wounds and Injuries

Central Study Contacts

Fia Navntoft

CONTACT

+46 31-722 30 00; fia.navntoft@molnlycke.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 29, 2024
• First Posted: March 20, 2024
• Study Start: February 16, 2024
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: May 23, 2024

Record last verified: 2024-05

Locations

ES (1)