Clinical Study to Compare 3 Multi-Layered Foam Dressings for the Management of Chronic Wounds

Launched by MOLNLYCKE HEALTH CARE AB · Sep 5, 2018

Keywords

ClinConnect Summary

The study will be conducted in an outpatient setting of an academic clinical center over a total period of four weeks (28 days, -1/+2).

The aim of this RCT is to evaluate and compare three different foam dressings in the local management of chronic wounds (i.e. venous leg ulcers (VLUs) and diabetic foot ulcers (DFUs)) in an outpatient setting. A bordered, five-layer, flexible foam dressing with soft silicone adhesive technology will be evaluated versus a hydropolymer, adhesive foam island dressing and a multi-layered, hydrocellular foam dressing with silicone adhesive, within three focus a...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male and female subjects 18-85 years of age with leg and foot ulcers (i.e. VLU, DFU).
• • 2. Signed informed consent.
• • 3. Subject and/or caregiver must be willing and able to tolerate multi-layered compression bandages when applicable and offloading footwear.
• • 4. Study subject must be available and able to visit the clinic weekly for the full 4-week period.
• Exclusion Criteria:
• • 1. Pressure ulcers should not be included. Pressure injury as defined by the National Pressure Ulcer Advisory Panel (NPUAP).
• • 2. Presence of local wound infection as determined by study doctor based on clinical signs and symptoms.
• • 3. Subject has any evidence of peripheral arterial disease (PAD).
• • 4. Subject diagnosed with malignancy other than cutaneous basal cell carcinoma.
• • 5. Subject has received growth factor therapy (e.g. autologous platelet-rich plasma gel, becaplermin, bilayered cell therapy, dermal substitute, extracellular matrix e.g. amnion, amniotic tissue) within 2 weeks of screening date.
• • 6. Pregnancy or lactation at time of study participation.
• • 7. Subject is currently receiving or has received radiation or chemotherapy within 3 months of randomization.
• • 8. Subject is currently enrolled or participated in another investigational device, drug or biological trial within 30 days of baseline of this study.
• • 9. Present history of alcohol or drug abuse.
• • 10. Known allergy/hypersensitivity to any of the components of the dressing.
• • 11. Subject not suitable for the investigation according to the investigator's judgment.