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Investigate impact of gelling fiber dressings on handling exudate in medium to high exuding wounds
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exufiber Ag + | Other | Gelling fibre dressing with silver to treat chronic wounds, acute wounds, and pressure ulcers. Data from these groups were analyzed separately with no comparative analysis. |
|
| Exufiber | Other | Gelling fibre dressing without silver to treat chronic wounds, acute wounds, and pressure ulcers. Data from these groups were analyzed separately with no comparative analysis. |
|
| Aquacel® Ag Extra | Other | Gelling fibre dressing with silver to treat chronic wounds, acute wounds, and pressure ulcers. Data from these groups were analyzed separately with no comparative analysis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exufiber Ag+ | Device | gelling fibre dressing with silver |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Exudate Status From Baseline to Last Visit | The primary endpoint measures exudate status based on dressing condition in categorical variables: Dry, Moist, Wet, Saturated, Leaking. Analysis of the change in exudate status (Decrease, Equal/Unchanged, Increase) from baseline to 4 weeks in the treatment groups was performed with a two-sided Sign test on the Intent To Treat (ITT) population at significance level 0.05. If a subject had missing values at 4 weeks (Visit 5), last observation carried forward (LOCF) was applied from Visit 2 (1 week). Three subjects treated with Exufiber Ag+ did not have evaluable data: 2 of the subjects did not complete a Visit 2 (1 week) or later visits (both subjects with a chronic wound); 1 subject (with a chronic wound) only completed the investigation until Visit 2, however no exudate status data were reported at Visit 2 for that subject. One subject treated with Exufiber did complete a Visit 2 (1 week) or later visit. | 4 weeks (28 days) or earlier if the wound is dry or healed |
| Measure | Description | Time Frame |
|---|---|---|
| 4-Week Wound Status | The overall wound status was evaluated by the Nurse/Investigator in ordered, categorical variables (Stagnated, Aggravated, Same as baseline, Improved, Healed), and presented with number of participants at week 4 (28 days). The total number (n) represents the total number of subjects included at the study visit; data were not always recorded for every subject, at every visit, for every data parameter (i.e. some data/answers are missing); Intent to Treat population with available data for this data point at Visit 5, or 4 weeks (28 days), is n=60 for Exufiber Ag+; n=13 for Exufiber; n=12 for Aquacel Ag Extra. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hadar Lev-Tov, MD, MAS | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Midwestern University | Glendale | Arizona | 85308 | United States | ||
| Center for Clinical Research, Inc. |
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All enrolled subjects were assigned to a treatment group and treated in compliance with the Instructions For Use. No subject was excluded from the intent-to-treat (ITT) and safety population during analysis.
Total enrolment was 109 subjects from 9 sites in the US, and was completed between 11 AUG 2017 and 12 JUN 2019.
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| ID | Title | Description |
|---|---|---|
| FG000 | Exufiber Ag+ | Gelling fiber dressing with silver to treat 'chronic wounds', 'acute wounds', and 'pressure ulcers' for the purpose of data analysis. Data from these groups were analyzed separately with no comparative analysis. |
| FG001 | Exufiber | Gelling fiber dressing without silver to treat 'chronic wounds', 'acute wounds', and 'pressure ulcers' for the purpose of data analysis. Data from these groups were analyzed separately with no comparative analysis. |
| FG002 | Aquacel Ag Extra | Gelling fiber dressing with silver to treat 'chronic wounds', 'acute wounds', and 'pressure ulcers' for the purpose of data analysis. Data from these groups were analyzed separately with no comparative analysis. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Exufiber Ag+ | Exufiber Ag+ included treatment for 'chronic wounds', 'acute wounds', and 'pressure ulcers' for the purpose of data analysis. Data from these groups were analyzed separately with no comparative analysis. |
| BG001 | Exufiber |
| 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 Exudate Status From Baseline to Last Visit | The primary endpoint measures exudate status based on dressing condition in categorical variables: Dry, Moist, Wet, Saturated, Leaking. Analysis of the change in exudate status (Decrease, Equal/Unchanged, Increase) from baseline to 4 weeks in the treatment groups was performed with a two-sided Sign test on the Intent To Treat (ITT) population at significance level 0.05. If a subject had missing values at 4 weeks (Visit 5), last observation carried forward (LOCF) was applied from Visit 2 (1 week). Three subjects treated with Exufiber Ag+ did not have evaluable data: 2 of the subjects did not complete a Visit 2 (1 week) or later visits (both subjects with a chronic wound); 1 subject (with a chronic wound) only completed the investigation until Visit 2, however no exudate status data were reported at Visit 2 for that subject. One subject treated with Exufiber did complete a Visit 2 (1 week) or later visit. | Intent To Treat (ITT) population with evaluable data to analyze change from baseline to last visit (n=75 for Exufiber Ag+; n=14 for Exufiber; n=16 for Aquacel Ag Extra) | Posted | Count of Participants | Participants | 4 weeks (28 days) or earlier if the wound is dry or healed |
All adverse event data were collected for a period of 2 years, throughout enrollment and follow-up of this study
There were no reports of death in any group throughout the study, and no reports of SAEs in the Exufiber group.
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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 | Exufiber Ag+ | Gelling fiber dressing with silver to treat 'chronic wounds', 'acute wounds', and 'pressure ulcers' for the purpose of data analysis. Data from these groups were analyzed separately with no comparative analysis. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Syncope | Nervous system disorders | Systematic Assessment | In-patient hospitalization following syncopal episode |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cellulitis of non-study wound | Infections and infestations | Systematic Assessment |
This clinical investigation was limited in that it was non-comparative and based on a limited number of subjects.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrea Marie Picchietti | Mölnlycke Health Care | 260 2583879 | andrea.picchietti@molnlycke.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 | Feb 19, 2019 | Jul 31, 2020 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 10, 2017 | Jul 31, 2020 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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Subjects were to be assigned in the following order:
The statistical analysis of the groups treated will be analysed separately with the same statistical methods.
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Open Label
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| Exufiber | Device | gelling fibre without silver |
|
| Aquacel Ag Extra | Device | gelling fibre with silver |
|
| At 4 weeks (28 days) |
| Wound Area Reduction (mm^2) | Wound area was calculated as an ellipse, i.e. Area = (Longest length/2) x (Longest width/2) x π, and was measured by a third-party validated software system. To account for subjects requiring debridement, wound area presented here are pooled data for wounds not debrided and after debridement. The total number (n) represents the total number of subjects included at the study visit with evaluable data; data were not always recorded for every subject, at every visit, for every data parameter (i.e. some data/answers are missing). Intent to Treat population with available data at Visit 5, or 4 weeks (28 days), or earlier if the wound is dry or healed, is n=59 for Exufiber Ag+; n=13 for Exufiber; n=12 for Aquacel Ag Extra. | Total treatment period of 4 weeks (28 days) or earlier if the wound is dry or healed |
| Frequency of Dressing Changes Between Visits | Frequency of dressing change was evaluated by the Nurse/Investigator. Dressing changes for each dressing were to be performed at least weekly, in line with the IFU and schedule of assessment. Values over 1 indicate dressing changes were required between study follow up visits, for any reason. | Total treatment period of 4 weeks (28 days) or earlier if the wound is dry or healed |
| Tissue Type of Wound Bed | Measurement of tissue types were collected separately, including necrotic tissue, sloughy tissue, granulation tissue, and epithelialized tissue. The change in percent of tissue type from baseline to 4 weeks are presented with number and percentages. The total number (n) represents the total number of subjects included at the study visit with evaluable data; data were not always recorded for every subject, at every visit, for every data parameter (i.e. some data/answers are missing); Intent to Treat population with available data at Visit 5, or 4 weeks (28 days), or earlier if the wound is dry or healed, is n=61 for Exufiber Ag+; n=13 for Exufiber; n=12 for Aquacel Ag Extra. | Total treatment period of 4 weeks (28 days) or earlier if the wound is dry or healed |
| Status of the Wound and Peri-wound Skin From Baseline to Last Visit: Malodour | Malodour was evaluated by the Nurse/Investigator in ordered categorical variables, None, Slight, Moderate, Strong. The Sign test was used for analysis of reported changes within groups from baseline to 4 weeks (Decrease, Equal/Unchanged, Increase), and described with number and percentages of reported changes. The total number (n) represents the total number of subjects included at the study visit; data were not always recorded for every subject, at every visit, for every data parameter (i.e. some data/answers are missing); Intent to Treat (ITT) population with available data to analyze change from baseline to Visit 5, at 4 weeks (28 days), is n=61 for Exufiber Ag+; n=13 for Exufiber; n=12 for Aquacel Ag Extra. | Total treatment period of 4 weeks (28 days) |
| Status of the Wound and Peri-wound Skin From Baseline to Last Visit: Redness/Irritation | Redness/Irritation under and outside the Primary dressing was evaluated by the Nurse/Investigator in and recorded as present (Yes) or not present (No). The Sign test was used for analysis of reported changes within groups from baseline to 4 weeks (Decrease, Equal/Unchanged, Increase), and presented with number and percentages of reported changes. The total number (n) represents the total number of subjects included at the study visit; data were not always recorded for every subject, at every visit, for every data parameter (i.e. some data/answers are missing); Intent to Treat (ITT) population with available data to analyze change from baseline to Visit 5, at 4 weeks (28 days), is n=61 for Exufiber Ag+; n=13 for Exufiber; n=12 for Aquacel Ag Extra. | Total treatment period of 4 weeks (28 days) |
| Status of the Wound and Peri-wound Skin From Baseline to Last Visit: Maceration | Maceration under and outside the Primary dressing was evaluated by the Nurse/Investigator in and recorded as present (Yes) or not present (No). The Sign test was used for analysis of reported changes within groups from baseline to 4 weeks (Decrease, Equal/Unchanged, Increase), and presented with number and percentages of reported changes. The total number (n) represents the total number of subjects included at the study visit; data were not always recorded for every subject, at every visit, for every data parameter (i.e. some data/answers are missing); Intent to Treat (ITT) population with available data to analyze change from baseline to Visit 5, at 4 weeks (28 days), is n=61 for Exufiber Ag+; n=13 for Exufiber; n=12 for Aquacel Ag Extra. | Total treatment period of 4 weeks (28 days) |
| Handling and Technical Performance of the Dressing | Handling and technical performance of the dressings were evaluated by the Nurse/Investigator in ordered categorical variables, Very Poor, Poor, Good, Very Good, and NA. We have presented the percentage of study participants reported with the category variable, Very Good, for each question at 4 weeks (28 days). The total number (n) represents the total number of subjects included at the study visit with evaluable data; data were not always recorded for every subject, at every visit, for every data parameter (i.e. some data/answers are missing); Intent to Treat population with available data at Visit 5, or 4 weeks (28 days), is n=63 for Exufiber Ag+; n=15 for Exufiber; n=16 for Aquacel Ag Extra. | At 4 weeks (28 days) |
| Comfort, Conformability, and Acceptability of the Dressings by Subject | Comfort, conformability, and acceptability of the dressings were evaluated by the Subject Participant in ordered categorical variables, Very Poor, Poor, Good, Very Good, and NA. We have presented the percentage of study participants reported with the category variable, Very Good, for each question at 4 weeks (28 days) or earlier if the wound dried or healed. The total number (n) represents the total number of subjects included at the study visit with evaluable data; data were not always recorded for every subject, at every visit, for every data parameter (i.e. some data/answers are missing); Intent to Treat population with available data at Visit 5, or 4 weeks (28 days), is n=63 for Exufiber Ag+; n=15 for Exufiber; n=16 for Aquacel Ag Extra. | At 4 weeks (28 days) or earlier if the wound is dry or healed |
| San Francisco |
| California |
| 94115 |
| United States |
| University of Miami | Miami | Florida | 33125 | United States |
| University of South Florida | Tampa | Florida | 33606 | United States |
| Boise VA Medical Center (Boise VAMC) M | Boise | Idaho | 83702 | United States |
| Northwell Health | Lake Success | New York | 11042 | United States |
| Jobst Vascular Institue (JVI) | Toledo | Ohio | 43606 | United States |
| Serena Group Research Institute | Pittsburgh | Pennsylvania | 15222 | United States |
| Lost to Follow-up |
|
Exufiber included treatment for 'chronic wounds' and 'acute wounds' for the purpose of data analysis. Data from these groups were analyzed separately with no comparative analysis. |
| BG002 | Aquacel Ag Extra | Aquacel Ag Extra included treatment for 'chronic wounds' and 'acute wounds' for the purpose of data analysis. Data from these groups were analyzed separately with no comparative analysis. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Exufiber Ag + | Gelling fibre dressing with silver to treat chronic wounds, acute wounds, and pressure ulcers. Data from these groups were analyzed separately with no comparative analysis. Exufiber Ag+: gelling fibre dressing with silver Exufiber: gelling fibre without silver Aquacel Ag Extra: gelling fibre with silver |
| OG001 | Exufiber | Gelling fibre dressing without silver to treat chronic wounds, acute wounds, and pressure ulcers. Data from these groups were analyzed separately with no comparative analysis. Exufiber Ag+: gelling fibre dressing with silver Exufiber: gelling fibre without silver Aquacel Ag Extra: gelling fibre with silver |
| OG002 | Aquacel® Ag Extra | Gelling fibre dressing with silver to treat chronic wounds, acute wounds, and pressure ulcers. Data from these groups were analyzed separately with no comparative analysis. Exufiber Ag+: gelling fibre dressing with silver Exufiber: gelling fibre without silver Aquacel Ag Extra: gelling fibre with silver |
|
|
|
| Secondary | 4-Week Wound Status | The overall wound status was evaluated by the Nurse/Investigator in ordered, categorical variables (Stagnated, Aggravated, Same as baseline, Improved, Healed), and presented with number of participants at week 4 (28 days). The total number (n) represents the total number of subjects included at the study visit; data were not always recorded for every subject, at every visit, for every data parameter (i.e. some data/answers are missing); Intent to Treat population with available data for this data point at Visit 5, or 4 weeks (28 days), is n=60 for Exufiber Ag+; n=13 for Exufiber; n=12 for Aquacel Ag Extra. | Intent to Treat population with available data at 4 weeks (28 days) (n=60 for Exufiber Ag+; n=13 for Exufiber; n=12 for Aquacel Ag Extra) | Posted | Count of Participants | Participants | At 4 weeks (28 days) |
|
|
|
| Secondary | Wound Area Reduction (mm^2) | Wound area was calculated as an ellipse, i.e. Area = (Longest length/2) x (Longest width/2) x π, and was measured by a third-party validated software system. To account for subjects requiring debridement, wound area presented here are pooled data for wounds not debrided and after debridement. The total number (n) represents the total number of subjects included at the study visit with evaluable data; data were not always recorded for every subject, at every visit, for every data parameter (i.e. some data/answers are missing). Intent to Treat population with available data at Visit 5, or 4 weeks (28 days), or earlier if the wound is dry or healed, is n=59 for Exufiber Ag+; n=13 for Exufiber; n=12 for Aquacel Ag Extra. | Intent to Treat population with available data at Visit 5, or 4 weeks (28 days), or earlier if the wound is dry or healed, is n=59 for Exufiber Ag+; n=13 for Exufiber; n=12 for Aquacel Ag Extra. | Posted | Mean | Standard Deviation | mm^2 | Total treatment period of 4 weeks (28 days) or earlier if the wound is dry or healed |
|
|
|
| Secondary | Frequency of Dressing Changes Between Visits | Frequency of dressing change was evaluated by the Nurse/Investigator. Dressing changes for each dressing were to be performed at least weekly, in line with the IFU and schedule of assessment. Values over 1 indicate dressing changes were required between study follow up visits, for any reason. | Intent to Treat population | Posted | Mean | Standard Deviation | dressing changes / 7 days | Total treatment period of 4 weeks (28 days) or earlier if the wound is dry or healed |
|
|
|
| Secondary | Tissue Type of Wound Bed | Measurement of tissue types were collected separately, including necrotic tissue, sloughy tissue, granulation tissue, and epithelialized tissue. The change in percent of tissue type from baseline to 4 weeks are presented with number and percentages. The total number (n) represents the total number of subjects included at the study visit with evaluable data; data were not always recorded for every subject, at every visit, for every data parameter (i.e. some data/answers are missing); Intent to Treat population with available data at Visit 5, or 4 weeks (28 days), or earlier if the wound is dry or healed, is n=61 for Exufiber Ag+; n=13 for Exufiber; n=12 for Aquacel Ag Extra. | Intent to Treat population with available data at Visit 5, or 4 weeks (28 days), or earlier if the wound is dry or healed, is n=61 for Exufiber Ag+; n=13 for Exufiber; n=12 for Aquacel Ag Extra. | Posted | Mean | Standard Deviation | change in percentage | Total treatment period of 4 weeks (28 days) or earlier if the wound is dry or healed |
|
|
|
| Secondary | Status of the Wound and Peri-wound Skin From Baseline to Last Visit: Malodour | Malodour was evaluated by the Nurse/Investigator in ordered categorical variables, None, Slight, Moderate, Strong. The Sign test was used for analysis of reported changes within groups from baseline to 4 weeks (Decrease, Equal/Unchanged, Increase), and described with number and percentages of reported changes. The total number (n) represents the total number of subjects included at the study visit; data were not always recorded for every subject, at every visit, for every data parameter (i.e. some data/answers are missing); Intent to Treat (ITT) population with available data to analyze change from baseline to Visit 5, at 4 weeks (28 days), is n=61 for Exufiber Ag+; n=13 for Exufiber; n=12 for Aquacel Ag Extra. | Intent to Treat (ITT) population with available data to analyze change from baseline to Visit 5, at 4 weeks (28 days), is n=61 for Exufiber Ag+; n=13 for Exufiber; n=12 for Aquacel Ag Extra. | Posted | Count of Participants | Participants | Total treatment period of 4 weeks (28 days) |
|
|
|
| Secondary | Status of the Wound and Peri-wound Skin From Baseline to Last Visit: Redness/Irritation | Redness/Irritation under and outside the Primary dressing was evaluated by the Nurse/Investigator in and recorded as present (Yes) or not present (No). The Sign test was used for analysis of reported changes within groups from baseline to 4 weeks (Decrease, Equal/Unchanged, Increase), and presented with number and percentages of reported changes. The total number (n) represents the total number of subjects included at the study visit; data were not always recorded for every subject, at every visit, for every data parameter (i.e. some data/answers are missing); Intent to Treat (ITT) population with available data to analyze change from baseline to Visit 5, at 4 weeks (28 days), is n=61 for Exufiber Ag+; n=13 for Exufiber; n=12 for Aquacel Ag Extra. | Intent to Treat (ITT) population with available data to analyze change from baseline to Visit 5, at 4 weeks (28 days), is n=61 for Exufiber Ag+; n=13 for Exufiber; n=12 for Aquacel Ag Extra. | Posted | Count of Participants | Participants | Total treatment period of 4 weeks (28 days) |
|
|
|
| Secondary | Status of the Wound and Peri-wound Skin From Baseline to Last Visit: Maceration | Maceration under and outside the Primary dressing was evaluated by the Nurse/Investigator in and recorded as present (Yes) or not present (No). The Sign test was used for analysis of reported changes within groups from baseline to 4 weeks (Decrease, Equal/Unchanged, Increase), and presented with number and percentages of reported changes. The total number (n) represents the total number of subjects included at the study visit; data were not always recorded for every subject, at every visit, for every data parameter (i.e. some data/answers are missing); Intent to Treat (ITT) population with available data to analyze change from baseline to Visit 5, at 4 weeks (28 days), is n=61 for Exufiber Ag+; n=13 for Exufiber; n=12 for Aquacel Ag Extra. | Intent to Treat (ITT) population with available data to analyze change from baseline to Visit 5, at 4 weeks (28 days), is n=61 for Exufiber Ag+; n=13 for Exufiber; n=12 for Aquacel Ag Extra. | Posted | Count of Participants | Participants | Total treatment period of 4 weeks (28 days) |
|
|
|
| Secondary | Handling and Technical Performance of the Dressing | Handling and technical performance of the dressings were evaluated by the Nurse/Investigator in ordered categorical variables, Very Poor, Poor, Good, Very Good, and NA. We have presented the percentage of study participants reported with the category variable, Very Good, for each question at 4 weeks (28 days). The total number (n) represents the total number of subjects included at the study visit with evaluable data; data were not always recorded for every subject, at every visit, for every data parameter (i.e. some data/answers are missing); Intent to Treat population with available data at Visit 5, or 4 weeks (28 days), is n=63 for Exufiber Ag+; n=15 for Exufiber; n=16 for Aquacel Ag Extra. | Intent to Treat population with available data at Visit 5, or 4 weeks (28 days), is n=63 for Exufiber Ag+; n=15 for Exufiber; n=16 for Aquacel Ag Extra. | Posted | Number | % of subjects | At 4 weeks (28 days) |
|
|
|
| Secondary | Comfort, Conformability, and Acceptability of the Dressings by Subject | Comfort, conformability, and acceptability of the dressings were evaluated by the Subject Participant in ordered categorical variables, Very Poor, Poor, Good, Very Good, and NA. We have presented the percentage of study participants reported with the category variable, Very Good, for each question at 4 weeks (28 days) or earlier if the wound dried or healed. The total number (n) represents the total number of subjects included at the study visit with evaluable data; data were not always recorded for every subject, at every visit, for every data parameter (i.e. some data/answers are missing); Intent to Treat population with available data at Visit 5, or 4 weeks (28 days), is n=63 for Exufiber Ag+; n=15 for Exufiber; n=16 for Aquacel Ag Extra. | Intent to Treat population with available data at Visit 5, or 4 weeks (28 days), is n=63 for Exufiber Ag+; n=15 for Exufiber; n=16 for Aquacel Ag Extra. | Posted | Number | % of subjects | At 4 weeks (28 days) or earlier if the wound is dry or healed |
|
|
|
| 0 |
| 78 |
| 7 |
| 78 |
| 14 |
| 78 |
| EG001 | Exufiber | Gelling fiber dressing without silver to treat 'chronic wounds', 'acute wounds', and 'pressure ulcers' for the purpose of data analysis. Data from these groups were analyzed separately with no comparative analysis. | 0 | 15 | 0 | 15 | 5 | 15 |
| EG002 | Aquacel Ag Extra | Gelling fiber dressing with silver to treat 'chronic wounds', 'acute wounds', and 'pressure ulcers' for the purpose of data analysis. Data from these groups were analyzed separately with no comparative analysis. | 0 | 16 | 1 | 16 | 2 | 16 |
|
| Arteriovenous fistula | Metabolism and nutrition disorders | Systematic Assessment | In-patient hospitalization for right arm fistula |
|
| Revisional transmetatarsal amputation right foot | Musculoskeletal and connective tissue disorders | Systematic Assessment | In-patient hospitalization for transmetatarsal amputation on right foot with full thickness wound along surgical site. |
|
| Infection on non-study foot | Skin and subcutaneous tissue disorders | Systematic Assessment | In-patient hospitalization for infection on non-study foot |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | In-patient hospitalization for pneumonia |
|
| Kidney injury | Renal and urinary disorders | Systematic Assessment | In-patient hospitalization for kidney injury |
|
| Shortness of breath | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | In-patient hospitalization for shortness of breath |
|
| Cellulitis | Infections and infestations | Systematic Assessment | In-patient hospitalization for cellulitis of the lower limb |
|
| Inability to eat | Metabolism and nutrition disorders | Systematic Assessment | In-patient hospitalization for inability to eat |
|
| Cellulitis of study wound | Infections and infestations | Systematic Assessment |
|
| Cold | General disorders | Systematic Assessment | Cold, or flu-like symptoms |
|
| Exacerbation of congestive heart failure | Cardiac disorders | Systematic Assessment |
|
| Fever | General disorders | Systematic Assessment |
|
| Infection of the study wound | Infections and infestations | Systematic Assessment |
|
| Itching of the non-study wound | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Maceration in study wound | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| New ulcer | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Osteomyelitis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Pain in study wound | General disorders | Systematic Assessment |
|
| Pain not related to study wound | General disorders | Systematic Assessment |
|
| Peripheral artery disease | Cardiac disorders | Systematic Assessment |
|
Not provided
Not provided
| Male |
|
| Sames as baseline |
|
| Improved |
|
| Healed |
|
|
| Change in percent of granulation tissue |
|
| Change in percent of epithelialisation |
|
| Increase |
|
| Increase |
|
| Increase |
|
|
| Removal in one piece |
|
| Ability to absorb exudate |
|
| Ability to absorb blood |
|
| Ability to retain exudate |
|
| Ability to retain slough |
|
| Ability to clean wound bed |
|
| Ability to retain balanced moist environment |
|
| Conformability to wound |
|
| Overall experience |
|
|
| Primary dressing remained in place |
|
| No stinging or burning |
|
| Overall experience |
|