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

NCT04621825 | Completed

• 1 other identifier: PHMB Silicone 001
• Study Type: interventional
• Target: 187
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

Antimicrobial PHMB; Silicone Foam; Chronic Wounds; Acute Wounds

Outcome Measures

Primary Outcomes (1)

• Effectiveness of the ActivHeal Silicone PHMB foam adhesive and Non Adhesive foam dressing

  Effectiveness (performance) of the ActivHeal Silicone PHMB will be evaluated for efficacy success according to the following success criteria: Reduction in signs and symptoms of infection from baseline as defined as * The change from the Investigator's opinion of infection being present to no longer being present, or * If the Investigator determines infection is still present there is improvement in severity of at least two. No worsening of any signs/ symptoms of infection at 6 weeks or if infection resolved prior to 6 weeks, that no new evidence of infection occurred during the 6 week treatment follow up.

  Immediately following initial assessment, dressing removal every 7 days follow up visits, for 6 weeks.

Secondary Outcomes (7)

• Safety of the ActivHeal Silicone PHMB foam adhesive and Non Adhesive foam dressing.

  Immediately following initial assessment, dressing removal every 7 days follow up visits, for 6 weeks.

• Effectiveness of the ActivHeal Silicone PHMB foam adhesive and Non Adhesive foam dressing in terms of wound progression

  Immediately following initial assessment, dressing removal every 7 days follow up visits, for 6 weeks.

• Effectiveness of the ActivHeal Silicone PHMB foam adhesive and Non Adhesive foam dressing in terms of pain.

  Immediately following initial assessment, dressing removal every 7 days follow up visits, for 6 weeks.

• Effectiveness of the ActivHeal Silicone PHMB foam adhesive and Non Adhesive foam dressing in terms of pain at dressing removal.

  Immediately following initial assessment, dressing removal every 7 days follow up visits, for 6 weeks.

• Effectiveness of the ActivHeal Silicone PHMB foam adhesive and Non Adhesive foam dressing in terms of peri wound skin.

  Immediately following initial assessment, dressing removal every 7 days follow up visits, for 6 weeks.

Study Arms (1)

Assigned intervention

EXPERIMENTAL

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.

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

Interventions

ActivHeal Silicone PHMB Foam Adhesive and Non Adhesive dressing. 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.

Assigned intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Advanced Medical Solutions Ltd.: lead
• Imarc Research, Inc.: collaborator

Study Sites (3)

Dr Thirumani Govender

Bellville, Cape Town, 7530, South Africa

Location

Delft Day Hospital Premises

Delft S., Cape Town, 7100, South Africa

Location

Brooklyn Chest Hospital

Ysterplaat, Cape Town, 7405,, South Africa

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• Thirumani Govender, MD

  TASK Clinical Research Centre 1 Smal Street Bellville, 7530

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2020
• First Posted: November 9, 2020
• Study Start: November 2, 2020
• Primary Completion: May 30, 2024
• Study Completion: July 30, 2024
• Last Updated: January 28, 2025

Record last verified: 2024-01

Locations

ZA (3)