NCT05045430

PMS Study to Confirm the Ongoing Safety and Performance of Silver II Non-woven Dressing in Chronic and Acute Wounds

Post Market Surveillance Study to Confirm the Ongoing Safety and Performance of Silver II Non-woven Dressing in Chronic and Acute Wounds

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 240 (actual)
• Sponsor: Advanced Medical Solutions Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Post Market Surveillance Study to confirm the safety and performance of Silver II Non-Woven Dressing in Chronic and Acute Wounds

Detailed description

The design of the study is an open-label, multicentre, single arm clinical trial in subjects with moderate to heavily exuding infected chronic and acute wounds consisting of Pressure ulcers, Leg ulcers, Diabetic ulcers, Post-operative surgical wounds, Graft and donor sites, Cavity wounds, Trauma wounds (dermal lesions, trauma injuries or incisions) and Superficial and partial thickness burns. The performance data from this study will support clinically meaningful rates of successful improvement in the signs and symptoms of infection, without re-infection during 6-week treatment and follow up period.

Conditions

• Wound

Interventions

Type	Name	Description
DEVICE	Silver II Non-Woven Dressing	Assigned interventions Subjects will undergo treatment of their chronic and acute wounds as indicated in instructions for use with Silver II Non-Woven dressings. Subjects will be evaluated as follows: Full Patient and wound assessment, Informed consent. Wound Assessment, application of dressings, (At each scheduled dressing change.) Wound Assessment, removal of dressings, (At each scheduled dressing change.) The patients will be evaluated at each dressing change over six-week period (per Advanced Medical Solution Product) or until the wound is healed to extent that the use of Silver II Non-Woven dressing is no longer indicated from the time that the patient has been recruited. The assessment of the presence and reduction of the signs and symptoms of Infection.

Timeline

• Start date: 2022-07-13
• Primary completion: 2025-09-30
• Completion: 2025-09-30
• First posted: 2021-09-16
• Last updated: 2025-11-25

Locations

8 sites across 2 countries: South Africa, United Kingdom