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

Advanced Medical Solutions

Status: Completed

Conditions: Wound

Treatments: Device: ActivHeal Silicone PHMB Foam Adhesive and Non Adhesive dressing.

Study type: Interventional

Funder types: Industry

Identifiers

NCT04621825

PHMB Silicone 001

Details and patient eligibility

About

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

Full 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.

Enrollment: 187 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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187 participants in 1 patient group

Assigned intervention

Experimental group

Description:

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.

Treatment:

Device: ActivHeal Silicone PHMB Foam Adhesive and Non Adhesive dressing.