ClinicalTrials.gg
RecruitingNCT07926386Updated Nov 9, 2026

Interventional Study to Describe the Utilization of Foam Dressings in Routine Clinical Practice, for the Treatment of Patients With Chronic Wounds in a Primary Healthcare Center in Italy.

An interventional study of Mepilex Border Flex in Chronic Wound Care, sponsored by Molnlycke Health Care AB. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-09.

Sponsored by Molnlycke Health Care AB · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Jul 2026, registered Nov 2026).
  • Started Jul 2026; still recruiting 3 months later.
Updated Nov 9, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

This study will take place at the primary care center in Milan. Approximately forty outpatients with chronic wounds who are currently treated with a foam dressing will be screened according to predefined inclusion and exclusion criteria. Eligible patients will be enrolled and switched to Mepilex® Border Flex. They will then be followed for approximately 4 weeks after the dressing change, in line with routine clinical practice.

02

Conditions studied

  • Chronic Wound Care
03

In context

Lead sponsor

Molnlycke Health Care AB is the lead sponsor of 59 studies on the registry; 8 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 3 (38%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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 agreeing to only have the dressing changed by the HCP.
  • Patients capable of signing the Form and answer the questions being asked.

Exclusion criteria

Exclusion Criteria:

  • Patients with any applicable 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
  • Patients who have been diagnosed as cognitively impaired
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Mepilex Border Flex

    Device: Mepilex Border Flex

Interventions

  • DeviceMepilex Border Flex

    Mepilex® Border Flex is designed for a wide range of exuding wounds such as pressure ulcers, leg and foot ulcers, traumatic wounds (e.g. skin tears) and surgical wounds. Mepilex® Border Flex can also be used on dry/necrotic wounds in combination with gels. Mepilex® Border Flex reduces postoperative blistering and may also be used as part of a prophylactic therapy to help prevent skin damage, e.g. pressure ulcers.

06

What researchers measure

Primary outcomes

  1. Primary Objective

    • To describe and explore the impact of the use of Mepilex® Border Flex in terms of number of dressing changes in a clinical practice setting, for the treatment of patients with chronic wounds.

    Time frame: From enrollment to the end of treatment at appr 4 weeks

07

Study locations

1 of 1 sites recruiting
08

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Nov 9, 2026
Show all 1 update
  1. Nov 9, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07926386
Collaborators
Niguarda Hospital
Responsible party
Sponsor
First posted
Nov 9, 2026
Start date
Jul 13, 2026
Primary completion
Dec 31, 2026 (estimated)
Completion
Mar 30, 2027 (estimated)
Last update
Nov 9, 2026

Study contacts

Fia Navntoft
Contact
Fia.navntoft@molnlycke.com
+4544141446

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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