Back to resultsTo Evaluate the Safety and Performance of the AMS ActivHeal Silicone Foam and the ActivHeal Silicone Foam Lite Dressing.
Primary Purpose
Wound
Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Assigned interventions.
Sponsored by
About this trial
This is an interventional treatment trial for Wound focused on measuring Silicone Foams, Chronic wounds, Acute wounds
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:
- 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.
Sites / Locations
- Poradnia Chorób Naczyń Obwodowych MIKOMED
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Assigned intervention.
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
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.
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).
Secondary Outcome Measures
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).
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).
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'.
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'.
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'.
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'.
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'.
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'.
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'.
Full Information
NCT ID
NCT04621838
First Posted
October 9, 2020
Last Updated
May 11, 2022
Sponsor
Advanced Medical Solutions Ltd.
Collaborators
Cliniscience Sp.
1. Study Identification
Unique Protocol Identification Number
NCT04621838
Brief Title
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
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
April 21, 2020 (Actual)
Primary Completion Date
January 30, 2022 (Actual)
Study Completion Date
February 28, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Advanced Medical Solutions Ltd.
Collaborators
Cliniscience Sp.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound
Keywords
Silicone Foams, Chronic wounds, Acute wounds
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
160 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Assigned intervention.
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Assigned interventions.
Intervention Description
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 Outcome Measure Information:
Title
Primary 1 Effectiveness of both Silicone Foam and Silicone Lite dressing will assessed in regards to the management of wound exudate.
Description
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.
Time Frame
After each dressing change up to 6 weeks following application of dressing
Title
Effectiveness of both Silicone Foam and Silicone Lite dressing will assessed in regards to Wound Healing progression.
Description
Success will be determined by no deterioration of the wound. The assessor will assess the wound size and the % tissue types within the wound.
Time Frame
After each dressing change up to 6 weeks following application of dressing
Title
Effectiveness of both Silicone Foam and Silicone Lite dressing will assessed in regards to the per wound skin conditions.
Description
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).
Time Frame
After each dressing change up to 6 weeks following application of dressing
Secondary Outcome Measure Information:
Title
Effectiveness of dressing removal of both the Silicone Foam and Silicone Lite dressing will assessed.
Description
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).
Time Frame
After each dressing change up to 6 weeks following application of dressing
Title
Effectiveness of both Silicone Foam and Silicone Lite dressing will assessed in regards to wound pain.
Description
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).
Time Frame
After each dressing change up to 6 weeks following application of dressing
Title
Effectiveness of both Silicone Foam and Silicone Lite dressing will assessed in regards to ease of use of the dressing.
Description
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'.
Time Frame
After each dressing change up to 6 weeks following application of dressing
Title
Effectiveness of both Silicone Foam and Silicone Lite dressing will assessed in regards to conformability of the dressing.
Description
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'.
Time Frame
After each dressing change up to 6 weeks following application of dressing
Title
Effectiveness of both Silicone Foam and Silicone Lite dressing will assessed in regards to dressing contours to anatomical contours of major wound site.
Description
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'.
Time Frame
After each dressing change up to 6 weeks following application of dressing
Title
Effectiveness of both Silicone Foam and Silicone Lite dressing will assessed in regards to overall acceptability of the dressing.
Description
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'.
Time Frame
After each dressing change up to 6 weeks following application of dressing
Title
Effectiveness of both Silicone Foam and Silicone Lite dressing will assessed in regards to peri wound skin condition.
Description
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'.
Time Frame
After each dressing change up to 6 weeks following application of dressing.
Title
Effectiveness of both Silicone Foam and Silicone Lite dressing will assessed in regards to the management of exudate.
Description
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'.
Time Frame
After each dressing change up to 6 weeks following application of dressing.
Title
Effectiveness of both Silicone Foam and Silicone Lite dressing will assessed in regards to wound healing progression.
Description
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'.
Time Frame
After each dressing change up to 6 weeks following application of dressing.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacek Mikosiński, MD, PhD
Organizational Affiliation
Poradnia Chorób Naczyń Obwodowych MIKOMED
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Katarzyna Rybołowicz, MD,PhD
Organizational Affiliation
Gabinet Ortopedyczny, Specjalistyczny Ośrodek Leczniczo-Badawczy,
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Konrad Pańczak, MD,PhD
Organizational Affiliation
NZOZ Twój Lekarz Kobierzyce,
Official's Role
Principal Investigator
Facility Information:
Facility Name
Poradnia Chorób Naczyń Obwodowych MIKOMED
City
Łódź
ZIP/Postal Code
94-238
Country
Poland
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
To Evaluate the Safety and Performance of the AMS ActivHeal Silicone Foam and the ActivHeal Silicone Foam Lite Dressing.
We'll reach out to this number within 24 hrs