NCT05690685

PMS Study of Silver I Alginate Non-Woven Dressing (Hydro-Alginate)

Post-market Surveillance Study to Confirm the Safety and Performance of Silver I Alginate Non-Woven Dressing (Hydro-Alginate) in Chronic and Acute Wounds

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Advanced Medical Solutions Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Post market surveillance study to confirm the ongoing safety and performance of Silver I Alginate Non-Woven Dressing (Hydro-Alginate) in chronic and acute wounds.

Detailed description

Design: The design of the study is an open-label, multicentre, single arm clinical trial in subjects with moderate to heavily exuding chronic and acute wounds consisting of Pressure ulcers and Donor sites. The rationale for the chosen study design and objectives is based on the requirement for further confirmation of the clinical effectiveness and safety of the dressing in routine clinical use, in terms of management of wound, management of bioburden, maintaining a moist wound environment, and exudate management. This post market study has been designed to be an in-market clinical evaluation. Using the assessment scale of "satisfactory" or "not satisfactory" will indicate whether the device is acceptable to the Healthcare Professional and therefore demonstrate the acceptability of the Silver I Alginate Non-Woven dressing (Hydro-Alginate). It is intended to recruit 25-30 subjects per wound type in support of providing evidence of effectiveness and safety of wound dressings. The prior CE-marking evaluation for this device lacked information pertaining to the use of the device in pressure ulcers or donor site wounds. Therefore, this study will address this gap. This study analysis will be descriptive in nature, for each wound type and will not be based on any stand-alone statistical hypotheses. The study endpoints have been chosen because they will demonstrate the safety and effectiveness of the dressing in routine clinical use.

Conditions

• Wound

Interventions

Type	Name	Description
DEVICE	Silver I Alginate Non-Woven Dressing (Hydro-Alginate)	Assigned interventions Subjects will undergo treatment of their chronic and acute wounds as indicated in instructions for use with Silver I 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 up-to six-week follow-up period.

Timeline

• Start date: 2023-05-16
• Primary completion: 2025-07-31
• Completion: 2025-07-31
• First posted: 2023-01-19
• Last updated: 2025-11-25

Locations

2 sites across 1 country: United Kingdom