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

NACompletedINTERVENTIONAL
Enrollment

187

Participants

Timeline

Start Date

November 2, 2020

Primary Completion Date

May 30, 2024

Study Completion Date

July 30, 2024

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."

Trial Locations (3)

7100

Delft Day Hospital Premises, Delft S.

7530

Dr Thirumani Govender, Bellville

7405,

Brooklyn Chest Hospital, Ysterplaat

Sponsors
All Listed Sponsors
collaborator

Imarc Research, Inc.

INDUSTRY

lead

Advanced Medical Solutions Ltd.

INDUSTRY