Mepilex Border Flex Utilization Pilot Spain | NCT06321978

Studies
Mepilex Border Flex Utilization Pilot Spain

NCT06321978

Sponsor

Molnlycke Health Care AB

Status

Unknown status

Last Update Posted

May 23, 2024Actual

Enrollment

40Estimated

Phase

Not provided

Conditions

Wound

Interventions

Mepilex Border Flex

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 16, 2024Actual

Primary Completion Date

May 31, 2024Estimated

Completion Date

May 31, 2024Estimated

First Submitted Date

Feb 29, 2024

First Submission Date that Met QC Criteria

Mar 13, 2024

First Posted Date

Mar 20, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 21, 2024

Last Update Posted Date

May 23, 2024Actual

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Study Group		Mepilex Border Flex dressing changes	Device: Mepilex Border Flex

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mepilex Border Flex	Device	Usage of Mepilex Border Flex according to intended use and standard of care.	Study Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Wound characteristics	Describe clinical characteristics of chronic wounds that are treated with foam dressings in routine clinical practice by HCP assessment	4 weeks
Wound management	Describe the management of chronic wounds in terms of frequency of dressing change, type of dressings used and reason for dressing change

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample