To Evaluate the Safety and Performance of the AMS ActivHeal Silicone Foam and the ActivHeal Silic… (NCT04621838) | Clinical Trial Compass
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 range18 Years
SexALL
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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.
✕. 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.)
What they're measuring
1
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
2
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
3
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