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

Primary Purpose

Wound

Status
Recruiting
Phase
Not Applicable
Locations
South Africa
Study Type
Interventional
Intervention
ActivHeal Silicone PHMB Foam Adhesive and Non Adhesive dressing.
Sponsored by
Advanced Medical Solutions Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wound focused on measuring Antimicrobial PHMB, Silicone Foam, Chronic Wounds, Acute Wounds

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Dr Thirumani GovenderRecruiting
  • Delft Day Hospital PremisesRecruiting
  • Brooklyn Chest HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Assigned intervention

Arm 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Safety of the ActivHeal Silicone PHMB foam adhesive and Non Adhesive foam dressing.
Safety will evaluated as incidence of device related adverse events.
Effectiveness of the ActivHeal Silicone PHMB foam adhesive and Non Adhesive foam dressing in terms of wound progression
Wound progression, assessed as the change from baseline to end of follow up. Monitoring of tissue types %,decrease in devitalised tissue, size and depth of wound.
Effectiveness of the ActivHeal Silicone PHMB foam adhesive and Non Adhesive foam dressing in terms of pain.
Change in patient pain will be assessed using Visual Analogue Scale, VAS, from baseline to end of follow up. Pain will assessed by completion of a Visual Analogue Scale VAS (0= no pain to 10 = worst pain imaginable).
Effectiveness of the ActivHeal Silicone PHMB foam adhesive and Non Adhesive foam dressing in terms of pain at dressing removal.
Patient pain will be assessed on removal of the ActivHeal Silicone PHMB foam adhesive and Non Adhesive foam dressing ActivHeal Silicone PHMB foam adhesive and Non Adhesive foam dressing. Pain will assessed by completion of a Visual Analogue Scale, VAS(0= no pain to 10 = worst pain imaginable).
Effectiveness of the ActivHeal Silicone PHMB foam adhesive and Non Adhesive foam dressing in terms of peri wound skin.
Changes in the peri wound skin, prevents maceration. (Allows the uptake of exudate into the dressing.) Relative score will be used to score maceration of zero (no maceration), one (minimal maceration), two (moderate maceration), and three (excessive maceration and need to withdraw patient from study). Success will be determined that over the evaluation an increased score would represent peri wound deterioration.
Effectiveness of the ActivHeal Silicone PHMB foam adhesive and Non Adhesive foam dressing in terms of dressing removal.
Did the dressing cause trauma on removal to the wound (prevents formulation of granulation tissue growth into the pores of the dressing). Clinician and patient satisfaction with the device (ease of removal and no pain or trauma on removal) will be assessed using a likert type scale. (Very satisfied, Satisfied and not Satisfied).
Effectiveness of the ActivHeal Silicone PHMB foam adhesive and Non Adhesive foam dressing in terms of repositioning.
Can the dressing be repositioned and or lifted, securely placed back down. Clinician satisfaction with the device (conformability & ease of use) will be assessed using a Likert type scale. (Very satisfied, Satisfied and not Satisfied)

Full Information

First Posted
October 13, 2020
Last Updated
March 1, 2022
Sponsor
Advanced Medical Solutions Ltd.
Collaborators
Imarc Research, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04621825
Brief Title
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

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 2, 2020 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Advanced Medical Solutions Ltd.
Collaborators
Imarc Research, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound
Keywords
Antimicrobial PHMB, Silicone Foam, Chronic Wounds, Acute Wounds

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
194 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Assigned intervention
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
ActivHeal Silicone PHMB Foam Adhesive and Non Adhesive dressing.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Effectiveness of the ActivHeal Silicone PHMB foam adhesive and Non Adhesive foam dressing
Description
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.
Time Frame
Immediately following initial assessment, dressing removal every 7 days follow up visits, for 6 weeks.
Secondary Outcome Measure Information:
Title
Safety of the ActivHeal Silicone PHMB foam adhesive and Non Adhesive foam dressing.
Description
Safety will evaluated as incidence of device related adverse events.
Time Frame
Immediately following initial assessment, dressing removal every 7 days follow up visits, for 6 weeks.
Title
Effectiveness of the ActivHeal Silicone PHMB foam adhesive and Non Adhesive foam dressing in terms of wound progression
Description
Wound progression, assessed as the change from baseline to end of follow up. Monitoring of tissue types %,decrease in devitalised tissue, size and depth of wound.
Time Frame
Immediately following initial assessment, dressing removal every 7 days follow up visits, for 6 weeks.
Title
Effectiveness of the ActivHeal Silicone PHMB foam adhesive and Non Adhesive foam dressing in terms of pain.
Description
Change in patient pain will be assessed using Visual Analogue Scale, VAS, from baseline to end of follow up. Pain will assessed by completion of a Visual Analogue Scale VAS (0= no pain to 10 = worst pain imaginable).
Time Frame
Immediately following initial assessment, dressing removal every 7 days follow up visits, for 6 weeks.
Title
Effectiveness of the ActivHeal Silicone PHMB foam adhesive and Non Adhesive foam dressing in terms of pain at dressing removal.
Description
Patient pain will be assessed on removal of the ActivHeal Silicone PHMB foam adhesive and Non Adhesive foam dressing ActivHeal Silicone PHMB foam adhesive and Non Adhesive foam dressing. Pain will assessed by completion of a Visual Analogue Scale, VAS(0= no pain to 10 = worst pain imaginable).
Time Frame
Immediately following initial assessment, dressing removal every 7 days follow up visits, for 6 weeks.
Title
Effectiveness of the ActivHeal Silicone PHMB foam adhesive and Non Adhesive foam dressing in terms of peri wound skin.
Description
Changes in the peri wound skin, prevents maceration. (Allows the uptake of exudate into the dressing.) Relative score will be used to score maceration of zero (no maceration), one (minimal maceration), two (moderate maceration), and three (excessive maceration and need to withdraw patient from study). Success will be determined that over the evaluation an increased score would represent peri wound deterioration.
Time Frame
Immediately following initial assessment, dressing removal every 7 days follow up visits, for 6 weeks.
Title
Effectiveness of the ActivHeal Silicone PHMB foam adhesive and Non Adhesive foam dressing in terms of dressing removal.
Description
Did the dressing cause trauma on removal to the wound (prevents formulation of granulation tissue growth into the pores of the dressing). Clinician and patient satisfaction with the device (ease of removal and no pain or trauma on removal) will be assessed using a likert type scale. (Very satisfied, Satisfied and not Satisfied).
Time Frame
Immediately following initial assessment, dressing removal every 7 days follow up visits, for 6 weeks.
Title
Effectiveness of the ActivHeal Silicone PHMB foam adhesive and Non Adhesive foam dressing in terms of repositioning.
Description
Can the dressing be repositioned and or lifted, securely placed back down. Clinician satisfaction with the device (conformability & ease of use) will be assessed using a Likert type scale. (Very satisfied, Satisfied and not Satisfied)
Time Frame
Immediately following initial assessment, dressing removal every 7 days follow up visits, for 6 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rebecca Forder, BA (Hons)
Phone
01606 545677
Email
Rebecca.forder@admedsol.com
First Name & Middle Initial & Last Name or Official Title & Degree
James Bartlett
Phone
01606 863500
Email
james.bartlett@admedsol.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thirumani Govender, MD
Organizational Affiliation
TASK Clinical Research Centre 1 Smal Street Bellville, 7530
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr Thirumani Govender
City
Bellville,
State/Province
Cape Town
ZIP/Postal Code
7530
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andreas Diacon, Prof.
Phone
021 917 1044/5
Email
ahd@sun.ac.za
First Name & Middle Initial & Last Name & Degree
Chantelle Holmgren, Dr.
Phone
021 917 1044/5
Email
dr.chantelle@task.org.za
Facility Name
Delft Day Hospital Premises
City
Delft S.
State/Province
Cape Town
ZIP/Postal Code
7100
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bryan G Esterhuizen, MD
Phone
021 954 1170
Email
dr.bryan@task.org.za
First Name & Middle Initial & Last Name & Degree
Madeleine Lourens, MD
Phone
021 954 1170
Email
dr.madeleine@task.org.za
Facility Name
Brooklyn Chest Hospital
City
Ysterplaat,
State/Province
Cape Town
ZIP/Postal Code
7405,
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caryn M. Upton, MD
Phone
021 510 2209
Email
dr.caryn@task.org.za
First Name & Middle Initial & Last Name & Degree
Diane E. Lavies, MD
Phone
021 510 2209
Email
dr.di@task.org.za

12. IPD Sharing Statement

Learn more about this trial

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

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