Clinical trial NCT04621825: Post Market Surveillance Study to Confirm Safety and Performance of Silicone PHMB Foam
Official title: Post Market Surveillance Study to Confirm the Safety and Performance of the Silicone Subcategory of PHMB Foam Dressings in Chronic and Acute Wounds
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wound
Keywords: Antimicrobial PHMB
Silicone Foam
Chronic Wounds
Acute Wounds
Lead sponsor: Advanced Medical Solutions Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Imarc Research, Inc.
First posted: 2020-11-09
Enrollment: 187
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Effectiveness of the ActivHeal Silicone PHMB foam adhesive and Non Adhesive foam dressing
timeFrame: Immediately following initial assessment, dressing removal every 7 days follow up visits, for 6 weeks.
Secondary outcomes:
measure: Safety of the ActivHeal Silicone PHMB foam adhesive and Non Adhesive foam dressing.
timeFrame: Immediately following initial assessment, dressing removal every 7 days follow up visits, for 6 weeks.
measure: Effectiveness of the ActivHeal Silicone PHMB foam adhesive and Non Adhesive foam dressing in terms of wound progression
timeFrame: Immediately following initial assessment, dressing removal every 7 days follow up visits, for 6 weeks.
measure: Effectiveness of the ActivHeal Silicone PHMB foam adhesive and Non Adhesive foam dressing in terms of pain.
timeFrame: Immediately following initial assessment, dressing removal every 7 days follow up visits, for 6 weeks.
measure: Effectiveness of the ActivHeal Silicone PHMB foam adhesive and Non Adhesive foam dressing in terms of pain at dressing removal.
timeFrame: Immediately following initial assessment, dressing removal every 7 days follow up visits, for 6 weeks.
measure: Effectiveness of the ActivHeal Silicone PHMB foam adhesive and Non Adhesive foam dressing in terms of peri wound skin.
timeFrame: Immediately following initial assessment, dressing removal every 7 days follow up visits, for 6 weeks.
measure: Effectiveness of the ActivHeal Silicone PHMB foam adhesive and Non Adhesive foam dressing in terms of dressing removal.
timeFrame: Immediately following initial assessment, dressing removal every 7 days follow up visits, for 6 weeks.
measure: Effectiveness of the ActivHeal Silicone PHMB foam adhesive and Non Adhesive foam dressing in terms of repositioning.
timeFrame: Immediately following initial assessment, dressing removal every 7 days follow up visits, for 6 weeks.
Other outcomes:
Locations:
city: Bellville,
country: South Africa
facility: Dr Thirumani Govender
state: Cape Town
city: Delft S.
country: South Africa
facility: Delft Day Hospital Premises
state: Cape Town
city: Ysterplaat,
country: South Africa
facility: Brooklyn Chest Hospital
state: Cape Town
Study officials:
affiliation: TASK Clinical Research Centre 1 Smal Street Bellville, 7530
name: Thirumani Govender, MD
role: PRINCIPAL_INVESTIGATOR
References: