Wound Clinical Trial
— MxBFlexUPESPOfficial 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.
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.
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. |
Country | Name | City | State |
---|---|---|---|
Spain | CS Ciudad Expo - Mairena de Aljarafe | Sevilla | Andalusia |
Lead Sponsor | Collaborator |
---|---|
Molnlycke Health Care AB |
Spain,
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 | HCP opinion | Describe the Healthcare professional's opinion regarding chronic wound management with foam dressings in regards of Usability and performance of dressing | 4 weeks | |
Secondary | Patient Experience | Describe patient experience with chronic wound management in regards to pain /VAS scale), comfort and abilty to stay in place. | 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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