Mepilex Border Flex Utilization Pilot Spain

Wound Clinical Trial

— MxBFlexUPESP  

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06321978
• Other study ID #: MxBFlexUP ESP
• Status: Recruiting
• Start date: February 16, 2024
• Est. completion date: May 31, 2024

Study information

• Verified date: May 2024
• Source: Molnlycke Health Care AB
• Contact: Fia Navntoft
• Phone: +46 31-722 30 00
• Email: fia.navntoft[@]molnlycke.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: May 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Wound

Intervention

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

Locations

Country	Name	City	State
Spain	CS Ciudad Expo - Mairena de Aljarafe	Sevilla	Andalusia

Sponsors (1)

Lead Sponsor	Collaborator
Molnlycke Health Care AB

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Wound characteristics	Describe clinical characteristics of chronic wounds that are treated with foam dressings in routine clinical practice by HCP assessment	4 weeks
Secondary	Wound management	Describe the management of chronic wounds in terms of frequency of dressing change, type of dressings used and reason for dressing change	4 weeks
Secondary	Technical Performance (HCP evaluation)	Several questions will be asked to evaluate the technical performance properties of the primary dressing. The following will be assessed by the investigator/designee using no/yes values: 1) Based on this patient, would you recommend Mepilex Border Flex for use in your organisation?; All other properties will be assessed by the investigator/designee using a 3-item scale of worse, same, better. These include: Ease of application; Ease of removal; Ability to conform to wound site; Ability to indicate the need for dressing change; Ability to stay in place; Trauma to the wound bed; Ability to indicate the need for dressing change; Trauma to the wound bed; Trauma to the peri-wound skin; Patient concordance; Overall dressing performance	4 weeks
Secondary	Patient Experience (PRO)	Patients are asked to rate the dressings in regards their experience; The following questions will be assessed by the investigator/designee using a 1-10 level visual analogue scale for pain: How wound you rate the pain in your wound today?; How would you rate the pain when Mepilex Border Flex was removed from your wound today?; The following will be assessed by the investigator/designee using no/yes values: *Would you recommend this treatment to a relative or friend?; All other properties will be assessed by the investigator/designee using a 4-item scale of very poor, poor, good, very good. These include: How would you rate the comfort of Mepilex Border Flex applied to your wound?; How would you rate Mepilex Border Flex used in regards to the ability to stay in place?; How would you rate your overall satisfaction regarding wound management (including the properties of Mepilex Border Flex and treatment of your wound)	4 weeks
Secondary	Costs	Estimate the weekly cost per patient associated with the dressings used in wound care episodes and the characteristics of use by evaluating type and size of wound and frequency of dressing change	4 weeks