RCT Exudate Management Cutimed Sorbion Product Range

Launched by BSN MEDICAL GMBH · Mar 7, 2024

Keywords

ClinConnect Summary

This clinical trial is studying two different types of advanced dressings designed to help manage fluid from venous leg ulcers (VLUs). These ulcers are wounds that can occur on the lower leg, often due to poor blood circulation. The main goal of the study is to find out which dressing is better at absorbing fluid, preventing skin irritation, and keeping the wound clean. By comparing these two dressings, researchers hope to improve the healing process for patients with these types of ulcers.

To participate in this trial, you need to be at least 18 years old and have a leg ulcer that has been present for at least four weeks but not longer than a year. The ulcer should be a specific size and depth, and you must be able to follow the study schedule. During the trial, you will be asked to use one of the dressings and attend regular check-ups to monitor your progress. It’s important to know that certain health conditions or treatments may prevent you from joining the study, but if you meet the criteria, this trial could provide you with effective wound care options.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Participant is informed about the trial, understands the nature of the study and provides written informed consent prior to study enrolment
• • 2. Participant is mentally and physically able to participate in this study
• • 3. Men, women, diverse ≥ 18 years
• • 4. Participant complies with study visit schedule
• • 5. Participant agrees to comply with all standard therapies (e.g., with regards to compression therapy)
• 6. Participant suffers from lower leg ulcer\* (including the ankle but not the feet) indicated to be treated with the study deviceinvestigational devices, requiring compression and fulfilling the following:
• • 7. Ulcer is not younger than 4 weeks and not older than 1 year
• • 8. Ulcer is ranging between 2 cm2 and 800 cm2
• • 9. One side of the ulcer is not extending 40 cm
• • 10. Depth of ulcer \< 2 cm
• • 11. Ankle-brachial pressure index (ABPI) of \>0.8 and ≤1.3, measurement not older than 12 months \* Participants with more than one ulcer are eligible for inclusion, however only one ulcer per patient will be included in the study.
• Exclusion Criteria:
• • 1. Participant already participates in this study with one ulcer (only one ulcer per participant is allowed)
• • 2. Participant is expected not to be willing or able to follow the study outlines and requirements
• • 3. Participant suffers from systemic infectious disease(s) known to negatively influence wound healing, such as AIDS
• • 4. Participant is undergoing an immuno-compromising therapy, such as systemic antineoplastic drugs and/or systemic corticosteroids
• • 5. Participant uses any medication that could potentially delay the wound healing ability
• • 6. Participant is an employee (staff or student) of the hospital site (institute) or the sponsor or is in a dependent relationship with a member of site or sponsor staff, e.g. child, spouse etc.
• • 7. Participant is pregnant or currently breastfeeding
• • 8. Participant reporting (and/or suspected by investigator) addiction from alcohol or drugs or is substituted e.g., by Methadone
• • 8. Participant suffers from alcohol or drug addiction or is substituted e.g., by Methadone 9. Participant is or has been included in another clinical investigation with medical devices or pharmaceutical drugs at present or during the past 30 days 10. Participant with a history of sensitivity to any of the components of the study product 11. Participant whose leg ulcers are clinically infected (e.g., erysipelas) or malignant 12. Study ulcer requiring negative pressure wound therapy or hyperbaric oxygen during the trial 13. The ulcer has exposed bone, tendon, ligaments and/or joint 14. History of radiation at the study ulcer site 15. Participant's lesion is a primary skin cancer 16. Participant's lesion is the manifestation of a metastasis