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Completed

NCT Number: NCT04621838

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

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.

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Key information

Conditions

Wound Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Poradnia Chorób Naczyń Obwodowych MIKOMED

Lodz, 94-238, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.)
  • Life expectancy of <6 months.

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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).

Secondary outcomes

  1. 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

    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).

  2. 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

    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).

  3. 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

    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'.

  4. 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

    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'.

  5. 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

    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'.

  6. 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

    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'.

  7. 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.

    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'.

  8. 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.

    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'.

  9. 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.

    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'.

Sponsors and collaborators

Lead sponsor

Advanced Medical Solutions Ltd.

Industry

Collaborators

  • Cliniscience Sp.

Registry information

Official study 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.

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Nov 9, 2020
Registry last updated
May 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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