NCT04634838

Efficacy of Wound Dressings With Copper Oxide

Pilot Efficacy Study of MedCu Wound Dressings With Copper Oxide in Treating Pressure Sores and Post-op Wounds

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: MedCu Technologies Ltd. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Thirty patients of 18-85 years of age, with 2-30 cm2 pressure ulcers or post-op wounds, will be recruited and treated with either wound dressing containing silver or wound dressings containing copper oxide microparticles. The efficacy of the two types of dressings in reducing the size and improving the condition of the wounds will be compared.

Detailed description

The study will be divided into 3 periods. Patients with pressure ulcers or post-operation wounds with wound areas of 2-30 cm2, who will accept participating in the study, pass all the accepted inclusion criteria, and sign the informed consent form, will be recruited. Then they will be treated with silver dressings for up to three weeks (first period). In case that the wounds will not show a reduction of at least 50% of the wound area during the first period, then the wounds will be treated with the copper oxide dressings for at least 3 weeks (second period). In case that there will be a clear improvement during the second period, the wounds may continue to be treated with the copper oxide dressings or with any other wound dressings according to the treating physician judgement and decision for an additional 3 weeks (third period) or earlier if the wound will be closed.

Conditions

• Pressure Ulcer
• Diabetic Foot Ulcer

Interventions

Type	Name	Description
DEVICE	MedCu Antibacterial Wound Dressings with Copper Oxide	Comparison between the efficacy of antibacterial wound dressings containing copper oxide microparticles to improve the wound healing of pressure sores and post-op wounds as compared to silver wound dressings

Timeline

• Start date: 2021-02-02
• Primary completion: 2023-04-30
• Completion: 2023-04-30
• First posted: 2020-11-18
• Last updated: 2023-10-23

Locations

1 site across 1 country: Israel