Clinical trial NCT04621838: To Evaluate the Safety and Performance of the AMS ActivHeal Silicone Foam and the ActivHeal Silicone Foam Lite Dressing.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wound
Keywords: Silicone Foams
Chronic wounds
Acute wounds
Lead sponsor: Advanced Medical Solutions Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Cliniscience Sp.
First posted: 2020-11-09
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: The patient population of this evaluation will consist of patients with either a chronic or acute wound of various wound types, according to the intended use of both the AMS ActivHeal Silicone Foam and ActivHeal Silicone foam lite dressing, and they meet study eligibility criteria.

Inclusion Criteria:

1. Males or females, age 18 years or above. (Females must not be pregnant and if of reproductive age should be using contraception).
2. Subjects who are able to understand and give informed consent to take part in the evaluation.
3. 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.
4. None to high levels of exudate

Exclusion Criteria:

1. Patients who decline the invitation to take part.
2. Patients who are known to be non-compliant with medical treatment,
3. Patients who are known to be sensitive to any of the dressing components.
4. Broken/ damaged or prone to blistering peri wound skin.
5. 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.
6. 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.)
7. Life expectancy of \<6 months.

Primary outcomes:
measure: 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
measure: 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
measure: 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
Secondary outcomes:
measure: Effectiveness of dressing removal of both the Silicone Foam and Silicone Lite dressing will assessed.
timeFrame: After each dressing change up to 6 weeks following application of dressing
measure: Effectiveness of both Silicone Foam and Silicone Lite dressing will assessed in regards to wound pain.
timeFrame: After each dressing change up to 6 weeks following application of dressing
measure: Effectiveness of both Silicone Foam and Silicone Lite dressing will assessed in regards to ease of use of the dressing.
timeFrame: After each dressing change up to 6 weeks following application of dressing
measure: Effectiveness of both Silicone Foam and Silicone Lite dressing will assessed in regards to conformability of the dressing.
timeFrame: After each dressing change up to 6 weeks following application of dressing
measure: Effectiveness of both Silicone Foam and Silicone Lite dressing will assessed in regards to dressing contours to anatomical contours of major wound site.
timeFrame: After each dressing change up to 6 weeks following application of dressing
measure: Effectiveness of both Silicone Foam and Silicone Lite dressing will assessed in regards to overall acceptability of the dressing.
timeFrame: After each dressing change up to 6 weeks following application of dressing
measure: Effectiveness of both Silicone Foam and Silicone Lite dressing will assessed in regards to peri wound skin condition.
timeFrame: After each dressing change up to 6 weeks following application of dressing.
measure: Effectiveness of both Silicone Foam and Silicone Lite dressing will assessed in regards to the management of exudate.
timeFrame: After each dressing change up to 6 weeks following application of dressing.
measure: 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.
Other outcomes:
Locations:
city: Łódź
country: Poland
facility: Poradnia Chorób Naczyń Obwodowych MIKOMED
Study officials:
affiliation: Poradnia Chorób Naczyń Obwodowych MIKOMED
name: Jacek Mikosiński, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gabinet Ortopedyczny, Specjalistyczny Ośrodek Leczniczo-Badawczy,
name: Katarzyna Rybołowicz, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: NZOZ Twój Lekarz Kobierzyce,
name: Konrad Pańczak, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: