CompletedNot Applicable

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

Poland160 participantsStarted 2020-04-21

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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

Exclusion criteria

. 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Primary 1 Effectiveness of both Silicone Foam and Silicone Lite dressing will assessed in regards to the management of wound exudate.

Timeframe: 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.

Timeframe: 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.

Timeframe: After each dressing change up to 6 weeks following application of dressing

Trial details

NCT IDNCT04621838

SponsorAdvanced Medical Solutions Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-01-30

View on ClinicalTrials.gov More Wound trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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

Exclusion criteria

. 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.

What they're measuring

Primary 1 Effectiveness of both Silicone Foam and Silicone Lite dressing will assessed in regards to the management of wound exudate.

Timeframe: 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.

Timeframe: 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.

Timeframe: After each dressing change up to 6 weeks following application of dressing