WoundNCT04621825
Post Market Surveillance Study to Confirm Safety and Performance of Silicone PHMB Foam
A study testing ActivHeal Silicone PHMB Foam Adhesive and Non Adhesive dressing. in people with Wound, run by Advanced Medical Solutions Ltd. at 3 sites in South Africa.
Trial summary
Post market surveillance study to confirm the safety and performance of Silicone Subcategory of PHMB Foam Dressings in Chronic and Acute Wounds. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wound
- What is being tested?
- ActivHeal Silicone PHMB Foam Adhesive and Non Adhesive dressing.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 187 participants
- Where
- 3 sitesSouth Africa
- Study dates
- 2 Nov 2020to 30 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
3 sites in 1 country.
South Africa3 sites
Dr Thirumani Govender
Bellville, Cape Town, 7530
Delft Day Hospital Premises
Delft S., Cape Town, 7100
Brooklyn Chest Hospital
Ysterplaat, Cape Town, 7405,
About this study
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
Post market surveillance study to confirm the safety and performance of Silicone Subcategory of PHMB Foam Dressings in Chronic and Acute Wounds.
Read the 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
- Being tested
- ActivHeal Silicone PHMB Foam Adhesive and Non Adhesive dressing.
- Keywords
- Antimicrobial PHMB, Silicone Foam, Chronic Wounds, Acute Wounds
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: ActivHeal Silicone PHMB Foam Adhesive and Non Adhesive dressing. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Safety will evaluated as incidence of device related adverse events.
Measured: 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
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.
Measured: 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.
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).
Measured: 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.
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).
Measured: 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.
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.
Measured: 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 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).
Measured: 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 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)
Measured: Immediately following initial assessment, dressing removal every 7 days follow up visits, for 6 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2020
- Study start2 Nov 2020
- Primary completion30 May 2024
- Study completion30 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WoundStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 187 participants (actual)
Sponsor and investigators
- Lead sponsor
- Advanced Medical Solutions Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Imarc Research, Inc.
- Responsible party
- Sponsor
- Investigators
- Thirumani Govender, MD, Principal investigator, TASK Clinical Research Centre 1 Smal Street Bellville, 7530
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04621825
- Sponsor's protocol ID
- PHMB Silicone 001
- Status last verified
- Jan 2024
- First submitted
- 13 Oct 2020
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04621825
- Acronym / sponsor ID
- PHMB Silicone 001
- Conditions
- Wound
- Keywords
- Antimicrobial PHMB, Silicone Foam, Chronic Wounds, Acute Wounds
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 187 participants (actual)
- Lead sponsor
- Advanced Medical Solutions Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Imarc Research, Inc.
- Study start
- 2 Nov 2020 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 9 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Assigned intervention | Experimental | Device: ActivHeal Silicone PHMB Foam Adhesive and Non Adhesive dressing.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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Assigned intervention |
Primary outcome
Effectiveness of the ActivHeal Silicone PHMB foam adhesive and Non Adhesive foam dressing
Time frame: Immediately following initial assessment, dressing removal every 7 days follow up visits, for 6 weeks.
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.
7 secondary outcomes
Safety of the ActivHeal Silicone PHMB foam adhesive and Non Adhesive foam dressing.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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 dressing removal.
Time frame: 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 repositioning.
Time frame: Immediately following initial assessment, dressing removal every 7 days follow up visits, for 6 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thirumani Govender, MD principal investigator
TASK Clinical Research Centre 1 Smal Street Bellville, 7530
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ActivHeal Silicone PHMB Foam Adhesive and Non Adhesive dressing. in people with Wound, run by Advanced Medical Solutions Ltd. at 3 sites in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of the ActivHeal Silicone PHMB foam adhesive and Non Adhesive foam dressing (time frame: Immediately following initial assessment, dressing removal every 7 days follow up visits, for 6 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2025.