NCT04621838

To Evaluate the Safety and Performance of the AMS ActivHeal Silicone Foam and the ActivHeal Silicone Foam Lite Dressing.

To Evaluate the Safety and Performance of the AMS ActivHeal Silicone Foam and the ActivHeal Silicone Foam Lite Dressing With Respect to Wound Exudate Management, Wound Healing Progression and Peri Wound Skin Condition.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: Advanced Medical Solutions Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To demonstrate the safety and performance of both AMS ActivHeal Silicone Foam and AMS ActivHeal Silicone Foam Lite dressings to both the patient and clinician in managing both chronic and acute wounds.

Detailed description

This PMCF study has been set up to investigate and assess residual risks in relation to the CE-marked AMS ActivHeal Silicone Foam and Silicone Foam Lite dressing . The purpose of this study is primarily to collect clinical follow-up data on the AMS ActivHeal Silicone Foam and Silicone Foam Lite dressing , as CE-marking was based on equivalence. The data and conclusions obtained from this study will be used to provide clinical evidence of safety and effectiveness for the clinical evaluation process.

Conditions

• Wound

Interventions

Type	Name	Description
OTHER	Assigned interventions.	Subjects will undergo treatment of their chronic and acute wounds as indicated in instructions for use, with Silicone Foam Dressing and Silicone Foam Lite Dressing. The patients will be evaluated at each dressing change over a six-week period (per Product) or until the wound is healed to extent that the use of the Silicone Foam and Silicone Foam Lite dressing is no longer indicated from the time that the patient has been recruited.

Timeline

• Start date: 2020-04-21
• Primary completion: 2022-01-30
• Completion: 2022-02-28
• First posted: 2020-11-09
• Last updated: 2022-05-12

Locations

1 site across 1 country: Poland