WoundNCT04621838

To Evaluate the Safety and Performance of the AMS ActivHeal Silicone Foam and the ActivHeal Silicone Foam Lite Dressing.

A study testing Assigned interventions. in people with Wound, run by Advanced Medical Solutions Ltd. at 1 site in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

To demonstrate the safety and performance of both AMS ActivHeal Silicone Foam and AMS ActivHeal Silicone Foam Lite dressings to both the patient and clinician in managing both 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?: Assigned interventions.
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 160 participants
Where: 1 sitePoland
Study dates: 21 Apr 2020to 28 Feb 2022
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

Males or females, age 18 years or above. (Females must not be pregnant and if of reproductive age should be using contraception).
Subjects who are able to understand and give informed consent to take part in the evaluation.
No local or systemic signs of infection, including new pain or increasing pain, erythema, local warmth, swelling, purulent discharge, pyrexia (in surgical wounds, typically five to seven days after surgery), delayed wound healing, abscess or malodour.
None to high levels of exudate

Who cannot join

Patients who decline the invitation to take part.
Patients who are known to be non-compliant with medical treatment,
Patients who are known to be sensitive to any of the dressing components.
Broken/ damaged or prone to blistering peri wound skin.
Presence of a clinically infected wound as determined by the presence of three or more of the following clinical signs: peri wound, erythema, pain between dressing changes, malodourous wound, abundant exudate, oedema, abscess, cellulitis, purulent discharge, discolouration, friable granulation tissue which bleeds easily.
Patients who have a current illness or condition which may interfere with wound healing in the last 30 days which may interfere with wound healing (carcinoma, connective tissue disease, autoimmune disease or alcohol or drug abuse.)
Life expectancy of <6 months.

Trial locations and contacts

1 site in 1 country.

Poland1 site

Poradnia Chorób Naczyń Obwodowych MIKOMED
Lodz, 94-238

Other trials in Poland

About this study

Official title: To Evaluate the Safety and Performance of the AMS ActivHeal Silicone Foam and the ActivHeal Silicone Foam Lite Dressing With Respect to Wound Exudate Management, Wound Healing Progression and Peri Wound Skin Condition.

Read the detailed description

This PMCF study has been set up to investigate and assess residual risks in relation to the CE-marked AMS ActivHeal Silicone Foam and Silicone Foam Lite dressing . The purpose of this study is primarily to collect clinical follow-up data on the AMS ActivHeal Silicone Foam and Silicone Foam Lite dressing , as CE-marking was based on equivalence. The data and conclusions obtained from this study will be used to provide clinical evidence of safety and effectiveness for the clinical evaluation process.

Conditions: Wound
Being tested: Assigned interventions.
Keywords: Silicone Foams, 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.

Assigned interventions.Other
Subjects will undergo treatment of their chronic and acute wounds as indicated in instructions for use, with Silicone Foam Dressing and Silicone Foam Lite Dressing.
The patients will be evaluated at each dressing change over a six-week period (per Product) or until the wound is healed to extent that the use of the Silicone Foam and Silicone Foam Lite dressing is no longer indicated from the time that the patient has been recruited.

Study groups in NCT04621838
Study group	Role	What they receive
Assigned intervention.	Experimental	Silicone Foam Dressing. Silicone Foam Lite. Subjects will undergo treatment of their chronic or acute wound as indicated in the instructions for use with Silicone Foam dressing and Silicone Foam Lite Dressing. Receives: Other: Assigned interventions.

What is being measured

The primary outcome is the main question the study is designed to answer.

Primary 1 Effectiveness of both Silicone Foam and Silicone Lite dressing will assessed in regards to the management of wound exudate.
Success will be determined by no deterioration of the wound or peri wound skin. A 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.
Measured: After each dressing change up to 6 weeks following application of dressing
Effectiveness of both Silicone Foam and Silicone Lite dressing will assessed in regards to Wound Healing progression.
Success will be determined by no deterioration of the wound. The assessor will assess the wound size and the % tissue types within the wound.
Measured: After each dressing change up to 6 weeks following application of dressing
Effectiveness of both Silicone Foam and Silicone Lite dressing will assessed in regards to the per wound skin conditions.
Success will be determined by no deterioration of peri wound skin. The peri wound skin will be assessed for maceration and signs of inflammation. A 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. This will be measured using VAS value (0= no erythema, redness and skin erosion and 10 = extensive erythema, redness and skin erosion).
Measured: After each dressing change up to 6 weeks following application of dressing

Secondary outcomes (9)

Effectiveness of dressing removal of both the Silicone Foam and Silicone Lite dressing will assessed.
The assessor will be required to record the pain score chosen by the patient pre removal of the dressing and record the pain score chosen by the patient during removal. Success will be determined by no increased in pain score and this will be measured using VAS value (0= no pain to 10= most pain imaginable).
Measured: After each dressing change up to 6 weeks following application of dressing
Effectiveness of both Silicone Foam and Silicone Lite dressing will assessed in regards to wound pain.
Pain associated with the wound. The assessor will be required to record the pain score chosen by the patient and record the pain score chosen by the patient. Success will be determined by no increase in pain score and this will be measured using VAS value. (0= no pain to 10= most pain imaginable).
Measured: After each dressing change up to 6 weeks following application of dressing
Effectiveness of both Silicone Foam and Silicone Lite dressing will assessed in regards to ease of use of the dressing.
Ease of use of the dressing. The assessor will be required to rate their level of satisfaction. Success will be determined by no unsatisfied level of satisfaction, and this will be measured using the following 'highly satisfied', 'satisfied' or 'unsatisfied'.
Measured: After each dressing change up to 6 weeks following application of dressing
Effectiveness of both Silicone Foam and Silicone Lite dressing will assessed in regards to conformability of the dressing.
Conformability of the dressing. The assessor will be required to rate their level of satisfaction. Success will be determined by no unsatisfied level of satisfaction, and this will be measured using the following 'highly satisfied', 'satisfied' or 'unsatisfied'.
Measured: After each dressing change up to 6 weeks following application of dressing
Effectiveness of both Silicone Foam and Silicone Lite dressing will assessed in regards to dressing contours to anatomical contours of major wound site.
Dressing contours to anatomical contours of major wound site. The assessor will be required to rate their level of satisfaction. Success will be determined by no unsatisfied level of satisfaction, and this will be measured using the following 'highly satisfied', 'satisfied' or 'unsatisfied'.
Measured: After each dressing change up to 6 weeks following application of dressing
Effectiveness of both Silicone Foam and Silicone Lite dressing will assessed in regards to overall acceptability of the dressing.
Overall acceptability of the dressing. The assessor will be required to rate their level of satisfaction. Success will be determined by no unsatisfied level of satisfaction, and this will be measured using the following 'highly satisfied', 'satisfied' or 'unsatisfied'.
Measured: After each dressing change up to 6 weeks following application of dressing
Effectiveness of both Silicone Foam and Silicone Lite dressing will assessed in regards to peri wound skin condition.
Peri wound skin condition satisfaction. The assessor will be required to rate their level of satisfaction. Success will be determined by no unsatisfied level of satisfaction, and this will be measured using the following 'highly satisfied', 'satisfied' or 'unsatisfied'.
Measured: After each dressing change up to 6 weeks following application of dressing.
Effectiveness of both Silicone Foam and Silicone Lite dressing will assessed in regards to the management of exudate.
Management of exudate satisfaction. The assessor will be required to rate their level of satisfaction. Success will be determined by no unsatisfied level of satisfaction, and this will be measured using the following 'highly satisfied', 'satisfied' or 'unsatisfied'.
Measured: After each dressing change up to 6 weeks following application of dressing.
Effectiveness of both Silicone Foam and Silicone Lite dressing will assessed in regards to wound healing progression.
Wound Healing Progression. The assessor will be required to rate their level of satisfaction. Success will be determined by no unsatisfied level of satisfaction, and this will be measured using the following 'highly satisfied', 'satisfied' or 'unsatisfied'.
Measured: After each dressing change up to 6 weeks following application of dressing.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Apr 202028 Feb 2022

First posted9 Nov 2020
Study start21 Apr 2020
Primary completion30 Jan 2022
Study completion28 Feb 2022

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: 160 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04621838
Sponsor's protocol ID: WD2018-Silicone-02
Status last verified: Mar 2022
First submitted: 9 Oct 2020
Last updated: 12 May 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Not yet recruiting
Safety Study of Microlyte DualGuard
Wound Closure, Wound Care
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Recruiting
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis

All Wound trials

Study at a glance

From the registry record, last updated by the sponsor on 12 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: To Evaluate the Safety and Performance of the AMS ActivHeal Silicone Foam and the ActivHeal Silicone Foam Lite Dressing With Respect to Wound Exudate Management, Wound Healing Progression and Peri Wound Skin Condition.
ClinicalTrials.gov ID: NCT04621838
Acronym / sponsor ID: WD2018-Silicone-02
Conditions: Wound
Keywords: Silicone Foams, Chronic wounds, Acute wounds
Study type: Interventional
Recruitment status: Completed
Enrolment: 160 participants (actual)
Lead sponsor: Advanced Medical Solutions Ltd.Industry (pharma, biotech, devices)
Collaborators: Cliniscience Sp.
Study start: 21 Apr 2020 (actual)
Primary completion: 30 Jan 2022 (actual)
Study completion: 28 Feb 2022 (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.

Detailed description

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	Other: Assigned interventions.Silicone Foam Dressing. Silicone Foam Lite. Subjects will undergo treatment of their chronic or acute wound as indicated in the instructions for use with Silicone Foam dressing and Silicone Foam Lite Dressing.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Males or females, age 18 years or above. (Females must not be pregnant and if of reproductive age should be using contraception).
Subjects who are able to understand and give informed consent to take part in the evaluation.
No local or systemic signs of infection, including new pain or increasing pain, erythema, local warmth, swelling, purulent discharge, pyrexia (in surgical wounds, typically five to seven days after surgery), delayed wound healing, abscess or malodour.
None to high levels of exudate

Key exclusion criteria (7 listed)

Patients who decline the invitation to take part.
Patients who are known to be non-compliant with medical treatment,
Patients who are known to be sensitive to any of the dressing components.
Broken/ damaged or prone to blistering peri wound skin.
Presence of a clinically infected wound as determined by the presence of three or more of the following clinical signs: peri wound, erythema, pain between dressing changes, malodourous wound, abundant exudate, oedema, abscess, cellulitis, purulent discharge, discolouration, friable granulation tissue which bleeds easily.

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
Assigned interventions.Subjects will undergo treatment of their chronic and acute wounds as indicated in instructions for use, with Silicone Foam Dressing and Silicone Foam Lite Dressing. The patients will be evaluated at each dressing change over a six-week period (per Product) or until the wound is healed to extent that the use of the Silicone Foam and Silicone Foam Lite dressing is no longer indicated from the time that the patient has been recruited.	Other	Assigned intervention.

Primary outcome

Primary 1 Effectiveness of both Silicone Foam and Silicone Lite dressing will assessed in regards to the management of wound exudate.
Time frame: After each dressing change up to 6 weeks following application of dressing
Success will be determined by no deterioration of the wound or peri wound skin. A 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.
Effectiveness of both Silicone Foam and Silicone Lite dressing will assessed in regards to Wound Healing progression.
Time frame: After each dressing change up to 6 weeks following application of dressing
Success will be determined by no deterioration of the wound. The assessor will assess the wound size and the % tissue types within the wound.
Effectiveness of both Silicone Foam and Silicone Lite dressing will assessed in regards to the per wound skin conditions.
Time frame: After each dressing change up to 6 weeks following application of dressing
Success will be determined by no deterioration of peri wound skin. The peri wound skin will be assessed for maceration and signs of inflammation. A 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. This will be measured using VAS value (0= no erythema, redness and skin erosion and 10 = extensive erythema, redness and skin erosion).

9 secondary outcomes

Effectiveness of dressing removal of both the Silicone Foam and Silicone Lite dressing will assessed.
Time frame: After each dressing change up to 6 weeks following application of dressing
Effectiveness of both Silicone Foam and Silicone Lite dressing will assessed in regards to wound pain.
Time frame: After each dressing change up to 6 weeks following application of dressing
Effectiveness of both Silicone Foam and Silicone Lite dressing will assessed in regards to ease of use of the dressing.
Time frame: After each dressing change up to 6 weeks following application of dressing
Effectiveness of both Silicone Foam and Silicone Lite dressing will assessed in regards to conformability of the dressing.
Time frame: After each dressing change up to 6 weeks following application of dressing
Effectiveness of both Silicone Foam and Silicone Lite dressing will assessed in regards to dressing contours to anatomical contours of major wound site.
Time frame: After each dressing change up to 6 weeks following application of dressing
Effectiveness of both Silicone Foam and Silicone Lite dressing will assessed in regards to overall acceptability of the dressing.
Time frame: After each dressing change up to 6 weeks following application of dressing
Effectiveness of both Silicone Foam and Silicone Lite dressing will assessed in regards to peri wound skin condition.
Time frame: After each dressing change up to 6 weeks following application of dressing.
Effectiveness of both Silicone Foam and Silicone Lite dressing will assessed in regards to the management of exudate.
Time frame: After each dressing change up to 6 weeks following application of dressing.
Effectiveness of both Silicone Foam and Silicone Lite dressing will assessed in regards to wound healing progression.
Time frame: After each dressing change up to 6 weeks following application of dressing.

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 12 May 2022.
Individual participant dataSharing planned: No

Related trials for Wound

Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Not yet recruiting
Safety Study of Microlyte DualGuard
Wound Closure, Wound Care
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Recruiting
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis

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.

Jacek Mikosiński, MD, PhD principal investigator

Poradnia Chorób Naczyń Obwodowych MIKOMED

Katarzyna Rybołowicz, MD,PhD principal investigator

Gabinet Ortopedyczny, Specjalistyczny Ośrodek Leczniczo-Badawczy,

Konrad Pańczak, MD,PhD principal investigator

NZOZ Twój Lekarz Kobierzyce,

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Assigned interventions. in people with Wound, run by Advanced Medical Solutions Ltd. at 1 site in Poland.

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 7 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 12 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. 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?

Primary 1 Effectiveness of both Silicone Foam and Silicone Lite dressing will assessed in regards to the management of wound exudate. (time frame: After each dressing change up to 6 weeks following application of dressing). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04621838.

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 12 May 2022.