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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06321978
Other study ID # MxBFlexUP ESP
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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