Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04621838
Other study ID # WD2018-Silicone-02
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 21, 2020
Est. completion date February 28, 2022

Study information

Verified date March 2022
Source Advanced Medical Solutions Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 160
Est. completion date February 28, 2022
Est. primary completion date January 30, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Assigned interventions.
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.

Locations

Country Name City State
Poland Poradnia Chorób Naczyn Obwodowych MIKOMED Lódz

Sponsors (2)

Lead Sponsor Collaborator
Advanced Medical Solutions Ltd. Cliniscience Sp.

Country where clinical trial is conducted

Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Primary 1 Effectiveness of both Silicone Foam and Silicone Lite dressing will assessed in regards to the management of wound exudate. 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. After each dressing change up to 6 weeks following application of dressing
Primary Effectiveness of both Silicone Foam and Silicone Lite dressing will assessed in regards to Wound Healing progression. Success will be determined by no deterioration of the wound. The assessor will assess the wound size and the % tissue types within the wound. After each dressing change up to 6 weeks following application of dressing
Primary Effectiveness of both Silicone Foam and Silicone Lite dressing will assessed in regards to the per wound skin conditions. 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). After each dressing change up to 6 weeks following application of dressing
Secondary Effectiveness of dressing removal of both the Silicone Foam and Silicone Lite dressing will assessed. 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). After each dressing change up to 6 weeks following application of dressing
Secondary Effectiveness of both Silicone Foam and Silicone Lite dressing will assessed in regards to wound pain. 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). After each dressing change up to 6 weeks following application of dressing
Secondary Effectiveness of both Silicone Foam and Silicone Lite dressing will assessed in regards to ease of use of the 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'. After each dressing change up to 6 weeks following application of dressing
Secondary Effectiveness of both Silicone Foam and Silicone Lite dressing will assessed in regards to conformability of the 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'. After each dressing change up to 6 weeks following application of dressing
Secondary Effectiveness of both Silicone Foam and Silicone Lite dressing will assessed in regards to dressing contours to anatomical contours of major wound site. 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'. After each dressing change up to 6 weeks following application of dressing
Secondary Effectiveness of both Silicone Foam and Silicone Lite dressing will assessed in regards to overall acceptability of the 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'. After each dressing change up to 6 weeks following application of dressing
Secondary Effectiveness of both Silicone Foam and Silicone Lite dressing will assessed in regards to peri wound skin condition. 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'. After each dressing change up to 6 weeks following application of dressing.
Secondary Effectiveness of both Silicone Foam and Silicone Lite dressing will assessed in regards to the management of exudate. 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'. After each dressing change up to 6 weeks following application of dressing.
Secondary Effectiveness of both Silicone Foam and Silicone Lite dressing will assessed in regards to wound healing progression. 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'. After each dressing change up to 6 weeks following application of dressing.
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03649308 - Negative Pressure Wound Therapy Compared to Traditional Care After Skin Grafting N/A
Recruiting NCT03674749 - The Effects of Meditation and Hyperbaric Oxygen Therapy on Chronic Wounds N/A
Completed NCT06464250 - The Effect of Bundle Approach on Foot Care Behaviors and Diabetic Wound Healing in Patients N/A
Withdrawn NCT03909503 - A Case Series Evaluating a Collagen Wound Dressing to Treat Wounds N/A
Completed NCT05297721 - Nurses' Level of Knowledge on Skin Tears: A Cross-Sectional Study
Recruiting NCT03386175 - Efficiency of Negative Pression Therapy With Instillation in the Debridement of Wound
Active, not recruiting NCT04701632 - Prevalence and Variables Associated With Depression in Subjects With Chronic Wounds Using PHQ-9 as a Screening Tool
Completed NCT05618496 - Multi-centre, Open-label, First-in-man Study With Epipad Used in Adult Patients N/A
Not yet recruiting NCT03640871 - HEAL Study: Healing Results, Efficacy and Acceptability of a New Contact Layer N/A
Completed NCT02399722 - Combination of a Polymeric Membrane Dressing Plus Negative Pressure Wound Therapy Against Negative Pressure Wound Therapy Alone N/A
Completed NCT04507724 - The Use of Biochemical Analyzes to Monitor the Development of Wounds
Recruiting NCT05556954 - Diabetic Foot Ulcers Microbiome and Pathogen Identification
Completed NCT03938584 - The Effect of Vitamin C on Wound Healing In Mandibular Fracture Patients N/A
Terminated NCT03723603 - An Evaluation of a Collagen Dressing to Treat Chronic, Stalled Lower-extremity Wounds N/A
Completed NCT03754426 - A Prospective, Pilot Evaluation of Device Equivalence
Recruiting NCT02643680 - Clinical Study of Biocellulose Wound Dressing Containing Silk Sericin and PHMB for STSG Donor Sites Phase 2
Recruiting NCT01913132 - PICO Above Incisions After Vascular Surgery N/A
Recruiting NCT01347489 - Cronic Pressure Wounds and Relation With Gender N/A
Recruiting NCT04621825 - Post Market Surveillance Study to Confirm Safety and Performance of Silicone PHMB Foam N/A
Withdrawn NCT03723577 - An Evaluation of a Fibrillar Collagen Dressing to Treat Chronic, Stalled Lower-extremity Wounds N/A