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

Not Applicable

Completed

• Conditions: Wound
• Interventions: Other: Assigned interventions.

• Registration Number: NCT04621838
• Lead Sponsor: Advanced Medical Solutions Ltd.

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.

Study Timeline

• Study Start: 2020-04-21
• Study First Submitted: 2020-10-09
• Study First Submitted QC: 2020-11-03
• Study First Posted: 2020-11-09
• Primary Completion: 2022-01-30
• Study Completion: 2022-02-28
• Status Verified: 2022-03
• Last Update Submitted: 2022-05-11
• Last Update Posted: 2022-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Assigned intervention.	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.

Primary Outcome Measures

Name	Time	Method
Effectiveness of both Silicone Foam and Silicone Lite dressing will assessed in regards to Wound Healing progression.	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.	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).
Primary 1 Effectiveness of both Silicone Foam and Silicone Lite dressing will assessed in regards to the management of wound exudate.	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Poradnia Chorób Naczyń Obwodowych MIKOMED; 🇵🇱 Łódź, Poland