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

NCT ID: NCT04621825

Last Updated: 2025-01-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 187 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-02
• Study Completion Date: 2024-07-30

Brief Summary

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

Detailed Description

The design of the study is an open label, multicentre, single arm trial with subjects with moderate to heavily exuding chronic and acute wounds consisting of pressure ulcers, leg ulcers, diabetic leg and foot ulcers, surgical wounds first degree 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 refection during 6- week treatment and follow up period.

Conditions

Wound

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Assigned intervention

ActivHeal Silicone PHMB Adhesive and Non Adhesive Foam.

Subjects will undergo treatment of their chronic or acute wound as indicated in the instructions for use with ActivHeal Silicone PHMB Adhesive and Non Adhesive Foam.

Group Type: EXPERIMENTAL

ActivHeal Silicone PHMB Foam Adhesive and Non Adhesive dressing.

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Have a pressure ulcer, leg ulcer, diabetic leg and foot ulcer, surgical wound, first degree superficial burns or partial thickness second degree burns that are infected following assessment of signs and symptoms of infection with moderate to heavy levels of exudate.
• Have wounds at high risk of infection.
• Males or females, age 18 years or above.
• Subjects who are able to understand and give informed consent to take part in the study.

Exclusion Criteria

• Subjects who are known to be non compliant with medical treatment.
• Subjects who are known to be sensitive to any of the device components, known sensitivity to PHMB.
• Subject is pregnant or actively breastfeeding.
• Subject has any significant or unstable medical or psychiatric condition, that in the opinion of the investigator, would interfere with his/her ability to participate in the study.
• Subject is currently in another clinical study.
• Patients who have a current illness or condition, or who have had an illness in the last 30 days which in the opinion of the investigator may interfere with wound healing (e.g. carcinoma, connective tissue disease, autoimmune disease or alcohol or drug abuse).
• Life expectancy of <6 months.
• Maximum burn area of >20% total body area in adults.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Imarc Research, Inc.

INDUSTRY

Sponsor Role: collaborator

Advanced Medical Solutions Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thirumani Govender, MD

Role: PRINCIPAL_INVESTIGATOR

TASK Clinical Research Centre 1 Smal Street Bellville, 7530

Locations

Dr Thirumani Govender

Bellville, Cape Town, South Africa

Delft Day Hospital Premises

Delft S., Cape Town, South Africa

Brooklyn Chest Hospital

Ysterplaat, Cape Town, South Africa

Countries

South Africa

Other Identifiers

PHMB Silicone 001

Identifier Type: -

Identifier Source: org_study_id