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Post Market Surveillance Study to Confirm Safety and Performance of Silicone PHMB Foam

NCT04621825 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 187

Last updated 2025-01-28

No results posted yet for this study

Summary

Post market surveillance study to confirm the safety and performance of Silicone Subcategory of PHMB Foam Dressings in Chronic and Acute Wounds.

Conditions

  • Wound

Interventions

DEVICE

ActivHeal Silicone PHMB Foam Adhesive and Non Adhesive dressing.

Assigned interventions Subjects will undergo treatment of their chronic and acute wounds as indicated in instructions for use with ActivHeal Silicone PHMB Foam adhesive and Non Adhesive Foam 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 a four - six-week period (per AMS Product) or until the wound is healed to extent that the use of the ActivHeal Silicone PHMB Foam adhesive and Non Adhesive Foam dressings. 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.

Sponsors & Collaborators

  • Imarc Research, Inc.

    collaborator INDUSTRY

  • Advanced Medical Solutions Ltd.

    lead INDUSTRY

Principal Investigators

  • Thirumani Govender, MD · TASK Clinical Research Centre 1 Smal Street Bellville, 7530

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-02
Primary Completion
2024-05-30
Completion
2024-07-30

Countries

  • South Africa

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04621825 on ClinicalTrials.gov