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The clinical study will evaluate the safety and effectiveness of the ALLEVYN Gentle Border. The study is a post-market clinical follow-up to assess clinical performance and safety of ALLEVYN Gentle Border with new wound contact layer to support performance claims.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALLEVYN Gentle border | Device | ALLEVYN Gentle border is a triple layer foam dressing consisting of a highly absorbent hydrocellular foam pad held between a perforated wound contact layer (WCL), which is coated with a soft silicone gel adhesive and a highly permeable outer top film. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Wound Area From Baseline to End of Study Visit | Change in wound area from baseline to end of study visit at 28 days was measured by wound photographs from a specific digital camera that standardized and calculated wound length, width, and depth automatically. | Baseline through 28 days (±3 days). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Wound Area From Baseline to 7 Days (±3 Days), 14 Days (±3 Days), and 21 Days (±3 Days) | Change in wound area from baseline to 7 days, 14 days and 21 days. Wound area was measured by photographs from a specific digital camera that standardized and calculated wound length, width, and depth automatically. | Baseline to 7 days (±3 days), 14 days (±3 days), and 21 days (±3 days) |
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Inclusion Criteria:
Signed written informed consent.
18 years of age or older.
Willing and able to make all required study visits.
Able to follow instructions and deemed capable of completing the CWIS questionnaire, Patient Assessment Scale and Pain Scale.
Presence of a moderately to highly exuding wound of at least 3cm2 in size.
Presence of a chronic wound of at least 6 weeks duration at the point of enrollment; full-thickness, partial thickness or shallow granulating wounds.
Chronic wounds include:
or
Presence of an acute wound at the point of enrollment; full thickness, partial thickness or shallow granulating wounds
Acute wounds include:
The patient has a wound size which can be treated with the available sizes and shapes of ALLEVYN Gentle Border. Cutting of the dressing is allowed, if needed. ALLEVYN Gentle Border can be cut and an aseptic technique should be used with cutting the dressing. Ensure any exposed foam areas are covered with an appropriate film dressing taking care not to cover the entire dressing.
Exclusion Criteria:
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Forty adult subjects with moderate to highly exuding wounds that require a dressing will be recruited. Only subjects with acute wounds or chronic wounds which are present > 6 weeks will be enrolled. Chronic wounds will include pressure ulcers, leg ulcers, diabetic foot ulcers. Acute wounds will include dehisced surgical or traumatic wounds. In order to ensure a balanced distribution on chronic and acute indications, at least 10 subjects with chronic wounds and at least 10 subjects with acute wounds will be enrolled.
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| Name | Affiliation | Role |
|---|---|---|
| Uwe Reinhold, MD | VZ Dermatologisches Zentrum Bonn | Principal Investigator |
| Cornelia Erfurt-Berge, MD | University Hospital Erlangen, Department of Dermatology | Principal Investigator |
| Ulrike Raap, MD | Klinikum Oldenburg, Universitätsklinik für Dermatologie und Allergologie | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier William Morey | Chalon-sur-Saône | 71321 | France | |||
| MVZ Dermatologisches Zentrum Bonn GmbH |
Three participants were terminated prior to study treatment, following consent, and did not meet eligibility criteria.
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| ID | Title | Description |
|---|---|---|
| FG000 | ALLEVYN Gentle Border | ALLEVYN Gentle border is a triple layer foam dressing consisting of a highly absorbent hydrocellular foam pad held between a perforated wound contact layer (WCL), which is coated with a soft silicone gel adhesive and a highly permeable outer top film. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ALLEVYN Gentle Border | ALLEVYN Gentle border is a triple layer foam dressing consisting of a highly absorbent hydrocellular foam pad held between a perforated wound contact layer (WCL), which is coated with a soft silicone gel adhesive and a highly permeable outer top film. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Wound Area From Baseline to End of Study Visit | Change in wound area from baseline to end of study visit at 28 days was measured by wound photographs from a specific digital camera that standardized and calculated wound length, width, and depth automatically. | All participants enrolled in the study that completed at least one post-baseline assessment for the specified outcome with available data at the time frame indicated using the last observation carried forward (LOCF). | Posted | Median | 95% Confidence Interval | square centimeters (cm^2) | Baseline through 28 days (±3 days). |
|
Following dressing application to study completion, up to 28 days.
Adverse events were collected for all participants enrolled in the study that received at least one study treatment (i.e., an application of ALLEVYN Gentle Border dressing).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ALLEVYN Gentle Border | ALLEVYN Gentle border is a triple layer foam dressing consisting of a highly absorbent hydrocellular foam pad held between a perforated wound contact layer (WCL), which is coated with a soft silicone gel adhesive and a highly permeable outer top film. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Wound complication | Injury, poisoning and procedural complications | Systematic Assessment | Possibly related to device |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Wound infection | Infections and infestations | Systematic Assessment | Possibly related to study device |
The original study protocol did not specify that participants should have a minimum wound area in the inclusion criteria. As such, several patients were enrolled with particularly small wound areas, limiting the ability to demonstrate suitable wound area reduction. Furthermore, there were eleven participants included who had low levels of exudate at baseline, which was a limiting factor in being able to demonstrate exudate management of the dressing.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Study Manager | Smith and Nephew | 1482673917 | +44 | rebecca.mcdonald@smith-nephew.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 21, 2019 | Nov 28, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D000092122 | Bronchiolitis Obliterans Syndrome |
| D007871 | Leg Ulcer |
| D017719 | Diabetic Foot |
| ID | Term |
|---|---|
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
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| Change in Wound Depth From Baseline to 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days) and 28 Days (±3 Days) | Wound depth at baseline, 7, 14, 21 and 28 days were measured by wound photographs from a specific digital camera that standardized and calculated wound length, width, and depth automatically. | Baseline, 7 days, 14 days, 21 days, 28 days |
| Change in Wound Volume From Baseline to 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days) and 28 Days (±3 Days) | Change in exudate wound volume measured from baseline to 7 days, 14 days, 21 days and 28 days. | Baseline, 7 days, 14 days, 21 days, and 28 days |
| Percentage Change in Wound Area From Baseline to 7 Days (±3 Days), 14 Days (±3 Days), and 21 Days (±3 Days) | Percentage change in wound area from baseline visit to visits 2 (7 Days), 3 (14 days) and 4 (21 days). | Baseline to 7 days (±3 days), 14 days (±3 days), and 21 days (±3 days) |
| Percentage Change in Wound Depth From Baseline to 7 Days (±3 Days), 14 Days (±3 Days), and 21 Days (±3 Days) | Percentage change in wound depth from baseline visit to visits 2 (7 Days), 3 (14 days) and 4 (21 days). | Baseline to 7 days (±3 days), 14 days (±3 days), and 21 days (±3 days) |
| Percentage Change in Wound Volume From Baseline to 7 Days (±3 Days), 14 Days (±3 Days), and 21 Days (±3 Days) | Percentage change in wound volume from baseline visit to visits 2 (7 Days), 3 (14 days) and 4 (21 days). | Baseline to 7 days (±3 days), 14 days (±3 days), and 21 days (±3 days) |
| Exudate Management: Number of Dressings With Leakage | The count of dressings applied on participants with exudate present that experienced any dressing leakage (Yes/No). | Dressing application to removal, up to 7 days (±3 Days) |
| Exudate Amount at 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days) and 28 Days (±3 Days) | Count of participants with wound exudate amounts identified as:
| 7 days (±3 Days), 14 days (±3 Days), 21 days (±3 Days), and 28 days (±3 Days) |
| Exudate Type at 7 (±3 Days), 14 (±3 Days), 21 (±3 Days) and 28 Days (±3 Days) | Count of participants with wound exudate types identified as:
| 7 days (±3 Days), 14 days (±3 Days), 21 days (±3 Days), and 28 days (±3 Days) |
| Level of Wound Odour at Baseline, 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days) and 28 Days (±3 Days) | Count of participants level of odour at baseline, 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days), and 28 Days (±3 Days) identified as:
| Baseline, 7 days (±3 Days), 14 days (±3 Days), 21 days (±3 Days), 28 days (±3 Days) |
| Reason for Dressing Change | Overall frequency of dressing changes categorized with the following reasons(Yes/No):
| Upon dressing removal, up to 7 days (±3 Days) |
| Condition of Surrounding Skin | The condition of surrounding skin (i.e., peri-wound) was assessed to ensure there was no compromise to skin condition as a result of dressing wear, which could impact the wound healing progress. Number of participants condition of the peri-wound was classified as:
| Baseline and 28 days (±3 Days) |
| Signs of Clinical Infection | Any signs of clinical infection (Yes/No) identified at 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days) and 28 Day (±3 Days) visits. | 7 days (±3 Days), 14 days (±3 Days), 21 days (±3 Days), 28 days (±3 Days) |
| Healing of Reference Wound | Wound healed (Yes/No) identified at 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days) and 28 day (±3 Days) visits. | 7 days (±3 Days), 14 days (±3 Days), 21 days (±3 Days), 28 days (±3 Days) |
| Average Dressing Wear Time | Average dressing wear time in days following application | Following dressing application, up to 7 days (±3 Days) |
| Overall Level of Pain on Dressing Application | Level of pain was scored on a scale from 0 to 10 with 0 indicating no pain and 10 indicating the worst pain. Participants provided their level of pain upon each dressing application at each scheduled study visit (7 days, 14 days, 21 days) or at any routine dressing change visit occurring between the scheduled visits. | Immediately after dressing application |
| Overall Level of Pain During Treatment | Level of pain was scored on a scale from 0 to 10 with 0 indicating no pain and 10 indicating the worst pain. Participants provided their level of pain during treatment after each dressing application at each scheduled study visit (7 days [ ±3 days], 14 days [ ±3 days], 21 days [ ±3 days]) or at any routine dressing change visit occurring between the scheduled visits. | During treatment (following each dressing application prior to removal), up to 7 days (±3 Days) |
| Overall Level Pain on Dressing Removal | Level of pain was scored on a scale from 0 to 10 with 0 indicating no pain and 10 indicating the worst pain. Participants provided their level of pain on dressing removal for each dressing applied at each scheduled study visit (7 days [ ±3 days], 14 days [ ±3 days], 21 days [ ±3 days]) or at any routine dressing change visit occurring between the scheduled visits. | Immediately upon dressing removal |
| Cardiff Wound Impact Schedule (CWIS): Quality of Life at Baseline, 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days) and 28 Days (±3 Days) | The Cardiff Wound Impact Schedule (CWIS) was collected at baseline and all study visits. Participants scored on a scale of 0 to 10 their perceived quality of life and satisfaction with quality of life. Higher scores indicate a better outcome. | Baseline, 7 days (±3 Days), 14 days (±3 Days), 21 days (±3 Days), and 28 days (±3 Days) |
| Cardiff Wound Impact Schedule (CWIS): Wellbeing, Physical Symptoms & Daily Living, and Social Life at Baseline, 7 (±3 Days), 14 (±3 Days), 21 (±3 Days), and 28 Days (±3 Days) | The Cardiff Wound Impact Schedule (CWIS) was collected at baseline and all study visits. Scores were on a scale from 0 to 100 with a higher score indicating a better outcome across three domains that included:
| Baseline, 7 days (±3 Days), 14 days (±3 Days), 21 days (±3 Days), 28 days (±3 Days) |
| Dressing Adherence (Retention) | The investigator determined retention by dressing adherence to the wound at 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days) and 28 Day (±3 Days) visits. Dressing adherence reported as the number of participants for each response to the question "Dressing still fully adhered?" from one of the following options:
| 7 days (±3 Days), 14 days (±3 Days), 21 days (±3 Days), 28 days (±3 Days) |
| Bunching Up of Dressing | The investigator determined any "bunching up" (i.e., bunching/overlap) of the dressing on the wound at 7 (±3 Days), 14 (±3 Days), 21 (±3 Days) and 28 day visits (±3 Days). Bunching of the dressing reported as the number of participants for each response to "Whether there is any bunching/overlap of dressing" from one of the following options:
| 7 days (±3 Days), 14 days (±3 Days), 21 days (±3 Days), 28 days (±3 Days) |
| Overall Percent of Dressing Lift | Overall percentage of dressing lift for each dressing application was determined from investigator responses following dressing removal at scheduled or routine dressing change visits to the question "Is the study dressing still fully adhered?" The following imputations were used when :
| Dressing application to removal, up to 7 days (±3 Days) |
| Dressing Comfort During Wear | Dressing comfort at 7 days (±3 Days) , 14 days (±3 Days), 21 days (±3 Days) and 28 day (±3 Days) visits determined by the number of participants with responses to "Dressing comfortable to wear since last visit" from one of the following options:
| 7 days (±3 Days), 14 days (±3 Days), 21 days( ±3 Days), 28 days (±3 Days) |
| Patient Assessment Scale: Leakage | Patient assessment scale completed from baseline visit through end of treatment visits, up to 28 Day (±3 days), using the participant response for each criteria to provide an overall score. Scores ranged from 0 to 10 with 0 indicating a worse outcome and 10 indicating the best outcome. Leakage was determined based on the response to "How have you found your experience in terms of leakage?" where 0 indicated unacceptable level of leakage and 10 indicated no leakage. | Baseline through end of treatment, up to 28 days (±3 days) |
| Patient Assessment Scale: Moisture | Patient assessment scale completed from baseline visit through end of treatment visits, up to 28 Day (±3 days), using the participant response for each criteria to provide an overall score. Scores ranged from 0 to 10 with 0 indicating a worse outcome and 10 indicating the best outcome. Moisture was determined based on the response to "How have you found your experience in terms of the feeling of moisture on your skin underneath the dressing" where 0 indicated unacceptable feeling of moisture and 10 indicated no feeling of moisture on the skin. | Baseline through end of treatment, up to 28 days (±3 days) |
| Patient Assessment Scale: Odour | Patient assessment scale completed from baseline visit through end of treatment visits, up to 28 Day (±3 days), using the participant response for each criteria to provide an overall score. Scores ranged from 0 to 10 with 0 indicating a worse outcome and 10 indicating the best outcome. Odour was determined based on the response to "How have you found your experience in terms of odour?" where 0 indicated unacceptable level of odour and 10 indicated no odour. | Baseline through end of treatment, up to 28 days (±3 days) |
| Patient Assessment Scale: Exudate | Patient assessment scale completed from baseline visit through end of treatment visits, up to 28 Day (±3 days), using the participant response for each criteria to provide an overall score. Scores ranged from 0 to 10 with 0 indicating a worse outcome and 10 indicating the best outcome. Exudate was determined based on the response to "How have you found your experience in terms of visible exudate?" where 0 indicated unacceptable level of visible exudate and 10 indicated no visible exudate. | Baseline through end of treatment, up to 28 days (±3 days) |
| Patient Assessment Scale: Protection | Patient assessment scale completed from baseline visit through end of treatment visits, up to 28 Day (±3 days), using the participant response for each criteria to provide an overall score. Scores ranged from 0 to 10 with 0 indicating a worse outcome and 10 indicating the best outcome. Protection was determined based on the response to "How protected did the dressing make your wound feel?" where 0 indicated unacceptable level of protection and 10 indicated very protected. | Baseline through end of treatment, up to 28 days (±3 days) |
| Patient Assessment Scale: Comfort | Patient assessment scale completed from baseline visit through end of treatment visits, up to 28 Day (±3 days), using the participant response for each criteria to provide an overall score. Scores ranged from 0 to 10 with 0 indicating a worse outcome and 10 indicating the best outcome. Comfort was determined based on the response to "How have you found your experience in terms of dressing comfort?" where 0 indicated unacceptable level of comfort and 10 indicated very comfortable. | Baseline through end of treatment, up to 28 days (±3 days) |
| Patient Assessment Scale: Showering | Patient assessment scale completed from baseline visit through end of treatment visits, up to 28 Day (±3 days), using the participant response for each criteria to provide an overall score. Scores ranged from 0 to 10 with 0 indicating a worse outcome and 10 indicating the best outcome. Comfort was determined based on the response to "How have you found your experience in terms of being able to maintain a normal showering routine? (NA if patient does not have a normal showering routine)" where 0 indicated unacceptable level of impact (unable to bathe) and 10 indicated no negative impact. | Baseline through end of treatment, up to 28 days (±3 days) |
| Bonn |
| 53111 |
| Germany |
| University Hospital Erlangen, Department of Dermatology | Erlangen | 91054 | Germany |
| Niels-Stensen-Kliniken Christliches Klinikum Melle GmbH | Melle | 49324 | Germany |
| Klinikum Oldenburg, University Clinic for Dermatology and Allergy | Oldenburg | 26133 | Germany |
| Northumbria Healthcare NHS Foundation Trust | Ashington | Northumberland | NE63 0HP | United Kingdom |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| Wound Type | Count of Participants | Participants |
|
| Wound Duration | Mean | Standard Deviation | days |
|
| Wound Area | Mean | Standard Deviation | cm^2 |
|
| Exudate Levels | Count of Participants | Participants |
|
|
|
| Secondary | Change in Wound Area From Baseline to 7 Days (±3 Days), 14 Days (±3 Days), and 21 Days (±3 Days) | Change in wound area from baseline to 7 days, 14 days and 21 days. Wound area was measured by photographs from a specific digital camera that standardized and calculated wound length, width, and depth automatically. | All participants enrolled in the study that completed at least one post-baseline assessment for the specified outcome with available data at the time frame indicated. | Posted | Median | 95% Confidence Interval | square centimeters (cm^2) | Baseline to 7 days (±3 days), 14 days (±3 days), and 21 days (±3 days) |
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| Secondary | Change in Wound Depth From Baseline to 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days) and 28 Days (±3 Days) | Wound depth at baseline, 7, 14, 21 and 28 days were measured by wound photographs from a specific digital camera that standardized and calculated wound length, width, and depth automatically. | All participants enrolled in the study that completed at least one post-baseline assessment for the specified outcome with available data at the time frame indicated. | Posted | Median | 95% Confidence Interval | millimeters (mm) | Baseline, 7 days, 14 days, 21 days, 28 days |
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| Secondary | Change in Wound Volume From Baseline to 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days) and 28 Days (±3 Days) | Change in exudate wound volume measured from baseline to 7 days, 14 days, 21 days and 28 days. | All participants enrolled in the study that completed at least one post-baseline assessment for the specified outcome with available data at the time frame indicated. | Posted | Median | 95% Confidence Interval | cubic centimeter (cm^3) | Baseline, 7 days, 14 days, 21 days, and 28 days |
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| Secondary | Percentage Change in Wound Area From Baseline to 7 Days (±3 Days), 14 Days (±3 Days), and 21 Days (±3 Days) | Percentage change in wound area from baseline visit to visits 2 (7 Days), 3 (14 days) and 4 (21 days). | All participants enrolled in the study that completed at least one post-baseline assessment for the specified outcome with available data at the time frame indicated. | Posted | Median | 95% Confidence Interval | percent change in wound area | Baseline to 7 days (±3 days), 14 days (±3 days), and 21 days (±3 days) |
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| Secondary | Percentage Change in Wound Depth From Baseline to 7 Days (±3 Days), 14 Days (±3 Days), and 21 Days (±3 Days) | Percentage change in wound depth from baseline visit to visits 2 (7 Days), 3 (14 days) and 4 (21 days). | All participants enrolled in the study that completed at least one post-baseline assessment for the specified outcome with available data at the time frame indicated. | Posted | Median | 95% Confidence Interval | percent change in wound depth | Baseline to 7 days (±3 days), 14 days (±3 days), and 21 days (±3 days) |
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| Secondary | Percentage Change in Wound Volume From Baseline to 7 Days (±3 Days), 14 Days (±3 Days), and 21 Days (±3 Days) | Percentage change in wound volume from baseline visit to visits 2 (7 Days), 3 (14 days) and 4 (21 days). | All participants enrolled in the study that completed at least one post-baseline assessment for the specified outcome with available data at the time frame indicated. | Posted | Median | 95% Confidence Interval | percent change in wound volume | Baseline to 7 days (±3 days), 14 days (±3 days), and 21 days (±3 days) |
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| Secondary | Exudate Management: Number of Dressings With Leakage | The count of dressings applied on participants with exudate present that experienced any dressing leakage (Yes/No). | Only participants enrolled in the study with any Exudate Levels present (i.e., scant, small, moderate, or large) that completed at least one post-baseline assessment for the specified outcome with available data at the time frame indicated. Of the 40 participants enrolled, 34 participants had exudate present. | Posted | Count of Units | dressings | Dressing application to removal, up to 7 days (±3 Days) | dressings | dressings |
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| Secondary | Exudate Amount at 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days) and 28 Days (±3 Days) | Count of participants with wound exudate amounts identified as:
| All participants enrolled in the study that completed at least one post-baseline assessment for the specified outcome with available data at the time frame indicated. | Posted | Count of Participants | Participants | 7 days (±3 Days), 14 days (±3 Days), 21 days (±3 Days), and 28 days (±3 Days) |
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| Secondary | Exudate Type at 7 (±3 Days), 14 (±3 Days), 21 (±3 Days) and 28 Days (±3 Days) | Count of participants with wound exudate types identified as:
| All participants enrolled in the study that completed at least one post-baseline assessment for the specified outcome with available data at the time frame indicated. | Posted | Count of Participants | Participants | 7 days (±3 Days), 14 days (±3 Days), 21 days (±3 Days), and 28 days (±3 Days) |
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| Secondary | Level of Wound Odour at Baseline, 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days) and 28 Days (±3 Days) | Count of participants level of odour at baseline, 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days), and 28 Days (±3 Days) identified as:
| All participants enrolled in the study that completed at least one post-baseline assessment for the specified outcome with available data at the time frame indicated. | Posted | Count of Participants | Participants | Baseline, 7 days (±3 Days), 14 days (±3 Days), 21 days (±3 Days), 28 days (±3 Days) |
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| Secondary | Reason for Dressing Change | Overall frequency of dressing changes categorized with the following reasons(Yes/No):
| All participants enrolled in the study that completed at least one post-baseline assessment for the specified outcome with available data at the time frame indicated. | Posted | Count of Units | dressings | Upon dressing removal, up to 7 days (±3 Days) | dressings | dressings |
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| Secondary | Condition of Surrounding Skin | The condition of surrounding skin (i.e., peri-wound) was assessed to ensure there was no compromise to skin condition as a result of dressing wear, which could impact the wound healing progress. Number of participants condition of the peri-wound was classified as:
| All participants enrolled in the study that completed at least one post-baseline assessment for the specified outcome with available data at the time frame indicated. | Posted | Count of Participants | Participants | Baseline and 28 days (±3 Days) |
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| Secondary | Signs of Clinical Infection | Any signs of clinical infection (Yes/No) identified at 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days) and 28 Day (±3 Days) visits. | All participants enrolled in the study that completed at least one post-baseline assessment for the specified outcome with available data at the time frame indicated. | Posted | Count of Participants | Participants | 7 days (±3 Days), 14 days (±3 Days), 21 days (±3 Days), 28 days (±3 Days) |
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| Secondary | Healing of Reference Wound | Wound healed (Yes/No) identified at 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days) and 28 day (±3 Days) visits. | All participants enrolled in the study that completed at least one post-baseline assessment for the specified outcome with available data at the time frame indicated. | Posted | Count of Participants | Participants | 7 days (±3 Days), 14 days (±3 Days), 21 days (±3 Days), 28 days (±3 Days) |
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| Secondary | Average Dressing Wear Time | Average dressing wear time in days following application | All participants enrolled in the study that completed at least one post-baseline assessment for the specified outcome with available data at the time frame indicated. | Posted | Mean | Standard Deviation | days | Following dressing application, up to 7 days (±3 Days) |
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| Secondary | Overall Level of Pain on Dressing Application | Level of pain was scored on a scale from 0 to 10 with 0 indicating no pain and 10 indicating the worst pain. Participants provided their level of pain upon each dressing application at each scheduled study visit (7 days, 14 days, 21 days) or at any routine dressing change visit occurring between the scheduled visits. | All participants enrolled in the study that completed at least one post-baseline assessment for the specified outcome with available data at the time frame indicated. | Posted | Mean | Standard Deviation | score on a scale | Immediately after dressing application | dressings | dressings |
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| Secondary | Overall Level of Pain During Treatment | Level of pain was scored on a scale from 0 to 10 with 0 indicating no pain and 10 indicating the worst pain. Participants provided their level of pain during treatment after each dressing application at each scheduled study visit (7 days [ ±3 days], 14 days [ ±3 days], 21 days [ ±3 days]) or at any routine dressing change visit occurring between the scheduled visits. | All participants enrolled in the study that completed at least one post-baseline assessment for the specified outcome with available data at the time frame indicated. | Posted | Mean | Standard Deviation | score on a scale | During treatment (following each dressing application prior to removal), up to 7 days (±3 Days) | dressings | dressings |
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| Secondary | Overall Level Pain on Dressing Removal | Level of pain was scored on a scale from 0 to 10 with 0 indicating no pain and 10 indicating the worst pain. Participants provided their level of pain on dressing removal for each dressing applied at each scheduled study visit (7 days [ ±3 days], 14 days [ ±3 days], 21 days [ ±3 days]) or at any routine dressing change visit occurring between the scheduled visits. | All participants enrolled in the study that completed at least one post-baseline assessment for the specified outcome with available data at the time frame indicated. | Posted | Mean | Standard Deviation | score on a scale | Immediately upon dressing removal | dressings | dressings |
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| Secondary | Cardiff Wound Impact Schedule (CWIS): Quality of Life at Baseline, 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days) and 28 Days (±3 Days) | The Cardiff Wound Impact Schedule (CWIS) was collected at baseline and all study visits. Participants scored on a scale of 0 to 10 their perceived quality of life and satisfaction with quality of life. Higher scores indicate a better outcome. | All participants enrolled in the study that completed at least one post-baseline assessment for the specified outcome with available data at the time frame indicated. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 7 days (±3 Days), 14 days (±3 Days), 21 days (±3 Days), and 28 days (±3 Days) |
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| Secondary | Cardiff Wound Impact Schedule (CWIS): Wellbeing, Physical Symptoms & Daily Living, and Social Life at Baseline, 7 (±3 Days), 14 (±3 Days), 21 (±3 Days), and 28 Days (±3 Days) | The Cardiff Wound Impact Schedule (CWIS) was collected at baseline and all study visits. Scores were on a scale from 0 to 100 with a higher score indicating a better outcome across three domains that included:
| All participants enrolled in the study that completed at least one post-baseline assessment for the specified outcome with available data at the time frame indicated. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 7 days (±3 Days), 14 days (±3 Days), 21 days (±3 Days), 28 days (±3 Days) |
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| Secondary | Dressing Adherence (Retention) | The investigator determined retention by dressing adherence to the wound at 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days) and 28 Day (±3 Days) visits. Dressing adherence reported as the number of participants for each response to the question "Dressing still fully adhered?" from one of the following options:
| All participants enrolled in the study that completed at least one post-baseline assessment for the specified outcome with available data at the time frame indicated. | Posted | Count of Participants | Participants | 7 days (±3 Days), 14 days (±3 Days), 21 days (±3 Days), 28 days (±3 Days) |
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| Secondary | Bunching Up of Dressing | The investigator determined any "bunching up" (i.e., bunching/overlap) of the dressing on the wound at 7 (±3 Days), 14 (±3 Days), 21 (±3 Days) and 28 day visits (±3 Days). Bunching of the dressing reported as the number of participants for each response to "Whether there is any bunching/overlap of dressing" from one of the following options:
| All participants enrolled in the study that completed at least one post-baseline assessment for the specified outcome with available data at the time frame indicated. | Posted | Count of Participants | Participants | 7 days (±3 Days), 14 days (±3 Days), 21 days (±3 Days), 28 days (±3 Days) |
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| Secondary | Overall Percent of Dressing Lift | Overall percentage of dressing lift for each dressing application was determined from investigator responses following dressing removal at scheduled or routine dressing change visits to the question "Is the study dressing still fully adhered?" The following imputations were used when :
| All participants enrolled in the study that completed at least one post-baseline assessment for the specified outcome with available data at the time frame indicated. | Posted | Mean | Standard Deviation | percentage of dressing lift | Dressing application to removal, up to 7 days (±3 Days) | dressings | dressings |
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| Secondary | Dressing Comfort During Wear | Dressing comfort at 7 days (±3 Days) , 14 days (±3 Days), 21 days (±3 Days) and 28 day (±3 Days) visits determined by the number of participants with responses to "Dressing comfortable to wear since last visit" from one of the following options:
| All participants enrolled in the study that completed at least one post-baseline assessment for the specified outcome with available data at the time frame indicated. | Posted | Count of Participants | Participants | 7 days (±3 Days), 14 days (±3 Days), 21 days( ±3 Days), 28 days (±3 Days) |
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| Secondary | Patient Assessment Scale: Leakage | Patient assessment scale completed from baseline visit through end of treatment visits, up to 28 Day (±3 days), using the participant response for each criteria to provide an overall score. Scores ranged from 0 to 10 with 0 indicating a worse outcome and 10 indicating the best outcome. Leakage was determined based on the response to "How have you found your experience in terms of leakage?" where 0 indicated unacceptable level of leakage and 10 indicated no leakage. | All participants enrolled in the study that completed at least one post-baseline assessment for the specified outcome with available data at the time frame indicated. | Posted | Mean | Standard Deviation | score on a scale | Baseline through end of treatment, up to 28 days (±3 days) | dressings | dressings |
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| Secondary | Patient Assessment Scale: Moisture | Patient assessment scale completed from baseline visit through end of treatment visits, up to 28 Day (±3 days), using the participant response for each criteria to provide an overall score. Scores ranged from 0 to 10 with 0 indicating a worse outcome and 10 indicating the best outcome. Moisture was determined based on the response to "How have you found your experience in terms of the feeling of moisture on your skin underneath the dressing" where 0 indicated unacceptable feeling of moisture and 10 indicated no feeling of moisture on the skin. | All participants enrolled in the study that completed at least one post-baseline assessment for the specified outcome with available data at the time frame indicated. | Posted | Mean | Standard Deviation | score on a scale | Baseline through end of treatment, up to 28 days (±3 days) | dressings | dressings |
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| Secondary | Patient Assessment Scale: Odour | Patient assessment scale completed from baseline visit through end of treatment visits, up to 28 Day (±3 days), using the participant response for each criteria to provide an overall score. Scores ranged from 0 to 10 with 0 indicating a worse outcome and 10 indicating the best outcome. Odour was determined based on the response to "How have you found your experience in terms of odour?" where 0 indicated unacceptable level of odour and 10 indicated no odour. | All participants enrolled in the study that completed at least one post-baseline assessment for the specified outcome with available data at the time frame indicated. | Posted | Mean | Standard Deviation | score on a scale | Baseline through end of treatment, up to 28 days (±3 days) | dressings | dressings |
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| Secondary | Patient Assessment Scale: Exudate | Patient assessment scale completed from baseline visit through end of treatment visits, up to 28 Day (±3 days), using the participant response for each criteria to provide an overall score. Scores ranged from 0 to 10 with 0 indicating a worse outcome and 10 indicating the best outcome. Exudate was determined based on the response to "How have you found your experience in terms of visible exudate?" where 0 indicated unacceptable level of visible exudate and 10 indicated no visible exudate. | All participants enrolled in the study that completed at least one post-baseline assessment for the specified outcome with available data at the time frame indicated. | Posted | Mean | Standard Deviation | score on a scale | Baseline through end of treatment, up to 28 days (±3 days) | dressings | dressings |
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| Secondary | Patient Assessment Scale: Protection | Patient assessment scale completed from baseline visit through end of treatment visits, up to 28 Day (±3 days), using the participant response for each criteria to provide an overall score. Scores ranged from 0 to 10 with 0 indicating a worse outcome and 10 indicating the best outcome. Protection was determined based on the response to "How protected did the dressing make your wound feel?" where 0 indicated unacceptable level of protection and 10 indicated very protected. | All participants enrolled in the study that completed at least one post-baseline assessment for the specified outcome with available data at the time frame indicated. | Posted | Mean | Standard Deviation | score on a scale | Baseline through end of treatment, up to 28 days (±3 days) | dressings | dressings |
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| Secondary | Patient Assessment Scale: Comfort | Patient assessment scale completed from baseline visit through end of treatment visits, up to 28 Day (±3 days), using the participant response for each criteria to provide an overall score. Scores ranged from 0 to 10 with 0 indicating a worse outcome and 10 indicating the best outcome. Comfort was determined based on the response to "How have you found your experience in terms of dressing comfort?" where 0 indicated unacceptable level of comfort and 10 indicated very comfortable. | All participants enrolled in the study that completed at least one post-baseline assessment for the specified outcome with available data at the time frame indicated. | Posted | Mean | Standard Deviation | score on a scale | Baseline through end of treatment, up to 28 days (±3 days) | dressings | dressings |
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| Secondary | Patient Assessment Scale: Showering | Patient assessment scale completed from baseline visit through end of treatment visits, up to 28 Day (±3 days), using the participant response for each criteria to provide an overall score. Scores ranged from 0 to 10 with 0 indicating a worse outcome and 10 indicating the best outcome. Comfort was determined based on the response to "How have you found your experience in terms of being able to maintain a normal showering routine? (NA if patient does not have a normal showering routine)" where 0 indicated unacceptable level of impact (unable to bathe) and 10 indicated no negative impact. | All participants enrolled in the study that completed at least one post-baseline assessment for the specified outcome with available data at the time frame indicated. | Posted | Mean | Standard Deviation | score on a scale | Baseline through end of treatment, up to 28 days (±3 days) | dressings | dressings |
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|
|
| 0 |
| 40 |
| 4 |
| 40 |
| 10 |
| 40 |
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| Pulmonary Oedema | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Subject discontinued from study due to SAE |
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| Urinary tract infection | Infections and infestations | Systematic Assessment |
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| Deep vein thrombosis | Vascular disorders | Systematic Assessment |
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| Periarthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Infection | Infections and infestations | Systematic Assessment |
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| Dermatitis | Skin and subcutaneous tissue disorders | Systematic Assessment | Definitely related to study device |
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| Wound complication | Injury, poisoning and procedural complications | Systematic Assessment | Subject discontinued due to AE |
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| Skin maceration | Skin and subcutaneous tissue disorders | Systematic Assessment | Definitely related to study device |
|
| Medical device site erosion | General disorders | Systematic Assessment | Definitely related to study device |
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| Urinary retention | Renal and urinary disorders | Systematic Assessment |
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| Cellulitis | Infections and infestations | Systematic Assessment |
|
Not provided
| D001982 |
| Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |
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| Baseline to 21 days (±3 days) |
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|
| Baseline to 21 Days |
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|
| Baseline to 28 Days |
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|
|
| Baseline to 21 Days (±3 Days) |
|
|
| Baseline to 28 Days (±3 Days) |
|
|
|
| Baseline to 21 days (±3 days) |
|
|
| Baseline to 28 Days |
|
|
|
| Baseline to 21 days (±3 days) |
|
|
| Baseline to 28 Days (±3 days) |
|
|
|
| Baseline to 21 days (±3 days) |
|
|
| Baseline to 28 Days (±3 days) |
|
|
| Moderate |
|
| Large |
|
| 14 days (±3 Days) |
|
| 21 days (±3 Days) |
|
| 28 days (±3 Days) |
|
| Serous |
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| Purulent |
|
| 14 days (±3 Days) |
|
| 21 days (±3 Days) |
|
| 28 days (±3 Days) |
|
| Moderate |
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| Strong |
|
| 7 days (±3 Days) |
|
|
| 14 days (±3 Days) |
|
|
| 21 days (±3 Days) |
|
|
| 28 days (±3 Days) |
|
|
| Yes |
|
| ALLEVYN been in place 7 days |
|
|
| Dressing saturated |
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|
| Strikethrough |
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|
| Leakage |
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| Pain |
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|
| Dressing fell off |
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| Dressing got wet during shower/bathing |
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| Subject removed dressing |
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| Other |
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|
| 50% to <75% wound covered |
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| 25% to <50% wound covered |
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| <25% wound covered |
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| Missing |
|
| 28 days (±3 Days) |
|
|
| 14 days (±3 Days) |
|
|
| 21 days (±3 Days) |
|
|
| 28 days (±3 Days) |
|
|
| 14 days (±3 Days) |
|
|
| 21 days (±3 Days) |
|
|
| 28 days (±3 Days) |
|
|
|
| Quality of Life: 14 days (±3 Days) |
|
|
| Quality of Life: 21 days (±3 Days) |
|
|
| Quality of Life: 28 days (±3 Days) |
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|
| Satisfaction with Quality of Life: Baseline |
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|
| Satisfaction with Quality of Life: 7 days (±3 Days) |
|
|
| Satisfaction with Quality of Life: 14 days (±3 Days) |
|
|
| Satisfaction with Quality of Life: 21 days (±3 Days) |
|
|
| Satisfaction with Quality of Life: 28 days (±3 Days) |
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|
|
| Wellbeing: 14 days (±3 Days) |
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|
| Wellbeing: 21 days (±3 Days) |
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|
| Wellbeing: 28 days (±3 Days) |
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|
| Physical Symptoms & Daily Living: Baseline |
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|
| Physical Symptoms & Daily Living: 7 days (±3 Days) |
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|
| Physical Symptoms & Daily Living: 14 days (±3 Days) |
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|
| Physical Symptoms & Daily Living: 21 days (±3 Days) |
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| Physical Symptoms & Daily Living: 28 days (±3 Days) |
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|
| Social Life: Baseline |
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|
| Social Life: 7 days (±3 Days) |
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|
| Social Life: 14 days (±3 Days) |
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|
| Social Life: 21 days (±3 Days) |
|
|
| Social Life: 28 days (±3 Days) |
|
|
| No, study dressing partially adhered |
|
| No, study dressing not adhered |
|
| 14 days (±3 Days) |
|
|
| 21 days (±3 Days) |
|
|
| 28 days (±3 Days) |
|
|
| Moderate |
|
| Excessive |
|
| 14 days (±3 Days) |
|
|
| 21 days (±3 Days) |
|
|
| 28 days (±3 Days) |
|
|
| Neither comfortable nor uncomfortable |
|
| Uncomfortable |
|
| Very uncomfortable |
|
| 14 days (±3 Days) |
|
|
| 21 days (±3 Days) |
|
|
| 28 days (±3 Days) |
|
|