Wounds and Injuries
Conditions
Brief summary
Investigate impact of gelling fiber dressings on handling exudate in medium to high exuding wounds
Interventions
DEVICEExufiber Ag+
gelling fibre dressing with silver
DEVICEExufiber
gelling fibre without silver
DEVICEAquacel Ag Extra
gelling fibre with silver
Sponsors
Molnlycke Health Care AB
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
Open Label
Intervention model description
Subjects were to be assigned in the following order: * Eligible Subjects 1 to 50 were to be assigned to the Exufiber Ag+ cohort * Eligible Subjects 51 to 65 were to be assigned to Exufiber * Eligible Subjects 66 to 85 were to be assigned to Aquacel Ag Extra * Eligible Subjects 86 to 105 were to be assigned to Exufiber Ag+ on eligible pressure ulcer subjects The statistical analysis of the groups treated will be analysed separately with the same statistical methods.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Signed Informed Consent Form * Both gender ≥ 18 years old * From Medium to High exuding wound
Exclusion criteria
* Known allergy or hypersensitivity to any of the treatment dressings * Pregnant or lactating females * Subjects with a target wound that is ≤1 cm2 * Subjects with a target wound that is a full thickness burn * Subjects with a target wound that is a full thickness pressure ulcer * Subjects with known immunodeficiency * Subject taking systemic antibiotics for wound infection * Subject were the target wound is located on an infected limb interfered by minimal blood flow in the opinion of the investigator * Subject with a target wound with unexplored enteric fistula * Subjects who in the opinion of the investigator, will have problems following the protocol * Subjects needing treatment with oxidizing agents such as hypochlorite solutions or hydrogen peroxide * Previously enrolled in the present investigation * Inclusion in other ongoing investigations at present that would preclude the subject from participating in this investigation as judged by the investigator * Involvement in the planning and conduct of the clinical investigation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Exudate Status From Baseline to Last Visit | 4 weeks (28 days) or earlier if the wound is dry or healed | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Wound Area Reduction (mm^2) | Total treatment period of 4 weeks (28 days) or earlier if the wound is dry or healed | 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. |
| Frequency of Dressing Changes Between Visits | Total treatment period of 4 weeks (28 days) or earlier if the wound is dry or healed | 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. |
| Tissue Type of Wound Bed | Total treatment period of 4 weeks (28 days) or earlier if the wound is dry or healed | 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. |
| Status of the Wound and Peri-wound Skin From Baseline to Last Visit: Malodour | Total treatment period of 4 weeks (28 days) | 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. |
| 4-Week Wound Status | At 4 weeks (28 days) | 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. |
| Status of the Wound and Peri-wound Skin From Baseline to Last Visit: Maceration | Total treatment period of 4 weeks (28 days) | 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. |
| Handling and Technical Performance of the Dressing | At 4 weeks (28 days) | 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. |
| Comfort, Conformability, and Acceptability of the Dressings by Subject | At 4 weeks (28 days) or earlier if the wound is dry or healed | 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. |
| Status of the Wound and Peri-wound Skin From Baseline to Last Visit: Redness/Irritation | Total treatment period of 4 weeks (28 days) | 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. |
Countries
United States
Participant flow
Recruitment details
Total enrolment was 109 subjects from 9 sites in the US, and was completed between 11 AUG 2017 and 12 JUN 2019.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 78 |
| Exufiber 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. | 15 |
| 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. | 16 |
| Total | 109 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 3 | 0 | 0 |
| Overall Study | Lost to Follow-up | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 3 | 0 | 0 |
Baseline characteristics
| Characteristic | Exufiber Ag+ | Exufiber | Aquacel Ag Extra | Total |
|---|---|---|---|---|
| Age, Continuous | 63.5 years STANDARD_DEVIATION 13.9 | 56.9 years STANDARD_DEVIATION 16.8 | 56.6 years STANDARD_DEVIATION 11.5 | 61.6 years STANDARD_DEVIATION 14.2 |
| Body Mass Index | 32.9 kg/m^2 STANDARD_DEVIATION 8.8 | 35.8 kg/m^2 STANDARD_DEVIATION 11.2 | 35.8 kg/m^2 STANDARD_DEVIATION 10.9 | 33.7 kg/m^2 STANDARD_DEVIATION 9.5 |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants |
| Region of Enrollment United States | 78 participants | 15 participants | 16 participants | 109 participants |
| Sex: Female, Male Female | 29 Participants | 9 Participants | 4 Participants | 42 Participants |
| Sex: Female, Male Male | 49 Participants | 6 Participants | 12 Participants | 67 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 78 | 0 / 15 | 0 / 16 |
| other Total, other adverse events | 14 / 78 | 5 / 15 | 2 / 16 |
| serious Total, serious adverse events | 7 / 78 | 0 / 15 | 1 / 16 |
Outcome results
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.
Time frame: 4 weeks (28 days) or earlier if the wound is dry or healed
Population: 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)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Exufiber Ag + | Change in Exudate Status From Baseline to Last Visit | Unchanged exudate status | 40 Participants |
| Exufiber Ag + | Change in Exudate Status From Baseline to Last Visit | Decreased exudate status | 27 Participants |
| Exufiber Ag + | Change in Exudate Status From Baseline to Last Visit | Increased exudate status | 8 Participants |
| Exufiber | Change in Exudate Status From Baseline to Last Visit | Unchanged exudate status | 6 Participants |
| Exufiber | Change in Exudate Status From Baseline to Last Visit | Increased exudate status | 5 Participants |
| Exufiber | Change in Exudate Status From Baseline to Last Visit | Decreased exudate status | 3 Participants |
| Aquacel® Ag Extra | Change in Exudate Status From Baseline to Last Visit | Unchanged exudate status | 8 Participants |
| Aquacel® Ag Extra | Change in Exudate Status From Baseline to Last Visit | Decreased exudate status | 7 Participants |
| Aquacel® Ag Extra | Change in Exudate Status From Baseline to Last Visit | Increased exudate status | 1 Participants |
p-value: 0.0019Sign test
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.
Time frame: At 4 weeks (28 days)
Population: 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)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Exufiber Ag + | 4-Week Wound Status | Improved | 48 Participants |
| Exufiber Ag + | 4-Week Wound Status | Aggravated | 5 Participants |
| Exufiber Ag + | 4-Week Wound Status | Healed | 4 Participants |
| Exufiber Ag + | 4-Week Wound Status | Stagnated | 2 Participants |
| Exufiber Ag + | 4-Week Wound Status | Sames as baseline | 1 Participants |
| Exufiber | 4-Week Wound Status | Stagnated | 1 Participants |
| Exufiber | 4-Week Wound Status | Improved | 7 Participants |
| Exufiber | 4-Week Wound Status | Sames as baseline | 1 Participants |
| Exufiber | 4-Week Wound Status | Healed | 1 Participants |
| Exufiber | 4-Week Wound Status | Aggravated | 3 Participants |
| Aquacel® Ag Extra | 4-Week Wound Status | Healed | 2 Participants |
| Aquacel® Ag Extra | 4-Week Wound Status | Aggravated | 0 Participants |
| Aquacel® Ag Extra | 4-Week Wound Status | Sames as baseline | 3 Participants |
| Aquacel® Ag Extra | 4-Week Wound Status | Improved | 6 Participants |
| Aquacel® Ag Extra | 4-Week Wound Status | Stagnated | 1 Participants |
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.
Time frame: At 4 weeks (28 days) or earlier if the wound is dry or healed
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Exufiber Ag + | Comfort, Conformability, and Acceptability of the Dressings by Subject | No stinging or burning | 87.5 % of subjects |
| Exufiber Ag + | Comfort, Conformability, and Acceptability of the Dressings by Subject | Primary dressing remained in place | 49.2 % of subjects |
| Exufiber Ag + | Comfort, Conformability, and Acceptability of the Dressings by Subject | Comfort while wearing | 44.3 % of subjects |
| Exufiber Ag + | Comfort, Conformability, and Acceptability of the Dressings by Subject | Overall experience | 45.6 % of subjects |
| Exufiber Ag + | Comfort, Conformability, and Acceptability of the Dressings by Subject | Ease of mobility | 41.0 % of subjects |
| Exufiber | Comfort, Conformability, and Acceptability of the Dressings by Subject | Ease of mobility | 64.3 % of subjects |
| Exufiber | Comfort, Conformability, and Acceptability of the Dressings by Subject | Comfort while wearing | 57.1 % of subjects |
| Exufiber | Comfort, Conformability, and Acceptability of the Dressings by Subject | Primary dressing remained in place | 64.3 % of subjects |
| Exufiber | Comfort, Conformability, and Acceptability of the Dressings by Subject | No stinging or burning | 85.7 % of subjects |
| Exufiber | Comfort, Conformability, and Acceptability of the Dressings by Subject | Overall experience | 64.3 % of subjects |
| Aquacel® Ag Extra | Comfort, Conformability, and Acceptability of the Dressings by Subject | Overall experience | 63.6 % of subjects |
| Aquacel® Ag Extra | Comfort, Conformability, and Acceptability of the Dressings by Subject | No stinging or burning | 100.0 % of subjects |
| Aquacel® Ag Extra | Comfort, Conformability, and Acceptability of the Dressings by Subject | Comfort while wearing | 66.7 % of subjects |
| Aquacel® Ag Extra | Comfort, Conformability, and Acceptability of the Dressings by Subject | Primary dressing remained in place | 58.3 % of subjects |
| Aquacel® Ag Extra | Comfort, Conformability, and Acceptability of the Dressings by Subject | Ease of mobility | 66.7 % of subjects |
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.
Time frame: Total treatment period of 4 weeks (28 days) or earlier if the wound is dry or healed
Population: Intent to Treat population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exufiber Ag + | Frequency of Dressing Changes Between Visits | 1.36 dressing changes / 7 days | Standard Deviation 1.77 |
| Exufiber | Frequency of Dressing Changes Between Visits | 0.511 dressing changes / 7 days | Standard Deviation 0.633 |
| Aquacel® Ag Extra | Frequency of Dressing Changes Between Visits | 3.56 dressing changes / 7 days | Standard Deviation 1.56 |
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.
Time frame: At 4 weeks (28 days)
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Exufiber Ag + | Handling and Technical Performance of the Dressing | Ease of removal of dressing without moistening | 56.4 % of subjects |
| Exufiber Ag + | Handling and Technical Performance of the Dressing | Ability to retain slough | 55.6 % of subjects |
| Exufiber Ag + | Handling and Technical Performance of the Dressing | Removal in one piece | 64.3 % of subjects |
| Exufiber Ag + | Handling and Technical Performance of the Dressing | Conformability to wound | 48.3 % of subjects |
| Exufiber Ag + | Handling and Technical Performance of the Dressing | Ability to absorb blood | 59.2 % of subjects |
| Exufiber Ag + | Handling and Technical Performance of the Dressing | Ability to retain exudate | 60.7 % of subjects |
| Exufiber Ag + | Handling and Technical Performance of the Dressing | Overall experience | 51.7 % of subjects |
| Exufiber Ag + | Handling and Technical Performance of the Dressing | Ability to clean wound bed | 49.2 % of subjects |
| Exufiber Ag + | Handling and Technical Performance of the Dressing | Ease of application of dressing | 57.8 % of subjects |
| Exufiber Ag + | Handling and Technical Performance of the Dressing | Ability to absorb exudate | 55.4 % of subjects |
| Exufiber Ag + | Handling and Technical Performance of the Dressing | Ability to retain balanced moist environment | 50.0 % of subjects |
| Exufiber | Handling and Technical Performance of the Dressing | Ease of removal of dressing without moistening | 85.7 % of subjects |
| Exufiber | Handling and Technical Performance of the Dressing | Removal in one piece | 92.9 % of subjects |
| Exufiber | Handling and Technical Performance of the Dressing | Ability to retain exudate | 92.9 % of subjects |
| Exufiber | Handling and Technical Performance of the Dressing | Ease of application of dressing | 100.0 % of subjects |
| Exufiber | Handling and Technical Performance of the Dressing | Ability to absorb exudate | 92.9 % of subjects |
| Exufiber | Handling and Technical Performance of the Dressing | Ability to absorb blood | 92.9 % of subjects |
| Exufiber | Handling and Technical Performance of the Dressing | Ability to retain slough | 92.9 % of subjects |
| Exufiber | Handling and Technical Performance of the Dressing | Ability to clean wound bed | 92.9 % of subjects |
| Exufiber | Handling and Technical Performance of the Dressing | Ability to retain balanced moist environment | 92.9 % of subjects |
| Exufiber | Handling and Technical Performance of the Dressing | Conformability to wound | 92.9 % of subjects |
| Exufiber | Handling and Technical Performance of the Dressing | Overall experience | 92.9 % of subjects |
| Aquacel® Ag Extra | Handling and Technical Performance of the Dressing | Conformability to wound | 60.0 % of subjects |
| Aquacel® Ag Extra | Handling and Technical Performance of the Dressing | Ability to clean wound bed | 44.4 % of subjects |
| Aquacel® Ag Extra | Handling and Technical Performance of the Dressing | Ease of application of dressing | 66.7 % of subjects |
| Aquacel® Ag Extra | Handling and Technical Performance of the Dressing | Removal in one piece | 63.6 % of subjects |
| Aquacel® Ag Extra | Handling and Technical Performance of the Dressing | Ability to retain balanced moist environment | 55.6 % of subjects |
| Aquacel® Ag Extra | Handling and Technical Performance of the Dressing | Ability to absorb exudate | 55.6 % of subjects |
| Aquacel® Ag Extra | Handling and Technical Performance of the Dressing | Ability to absorb blood | 55.6 % of subjects |
| Aquacel® Ag Extra | Handling and Technical Performance of the Dressing | Ability to retain exudate | 55.6 % of subjects |
| Aquacel® Ag Extra | Handling and Technical Performance of the Dressing | Ease of removal of dressing without moistening | 63.6 % of subjects |
| Aquacel® Ag Extra | Handling and Technical Performance of the Dressing | Overall experience | 60.0 % of subjects |
| Aquacel® Ag Extra | Handling and Technical Performance of the Dressing | Ability to retain slough | 55.6 % of subjects |
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.
Time frame: Total treatment period of 4 weeks (28 days)
Population: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Exufiber Ag + | Status of the Wound and Peri-wound Skin From Baseline to Last Visit: Maceration | Increase | 6 Participants |
| Exufiber Ag + | Status of the Wound and Peri-wound Skin From Baseline to Last Visit: Maceration | Equal/Unchanged | 39 Participants |
| Exufiber Ag + | Status of the Wound and Peri-wound Skin From Baseline to Last Visit: Maceration | Decrease | 16 Participants |
| Exufiber | Status of the Wound and Peri-wound Skin From Baseline to Last Visit: Maceration | Increase | 0 Participants |
| Exufiber | Status of the Wound and Peri-wound Skin From Baseline to Last Visit: Maceration | Decrease | 0 Participants |
| Exufiber | Status of the Wound and Peri-wound Skin From Baseline to Last Visit: Maceration | Equal/Unchanged | 13 Participants |
| Aquacel® Ag Extra | Status of the Wound and Peri-wound Skin From Baseline to Last Visit: Maceration | Equal/Unchanged | 7 Participants |
| Aquacel® Ag Extra | Status of the Wound and Peri-wound Skin From Baseline to Last Visit: Maceration | Decrease | 5 Participants |
| Aquacel® Ag Extra | Status of the Wound and Peri-wound Skin From Baseline to Last Visit: Maceration | Increase | 0 Participants |
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.
Time frame: Total treatment period of 4 weeks (28 days)
Population: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Exufiber Ag + | Status of the Wound and Peri-wound Skin From Baseline to Last Visit: Malodour | Equal/Unchanged | 45 Participants |
| Exufiber Ag + | Status of the Wound and Peri-wound Skin From Baseline to Last Visit: Malodour | Decrease | 3 Participants |
| Exufiber Ag + | Status of the Wound and Peri-wound Skin From Baseline to Last Visit: Malodour | Increase | 13 Participants |
| Exufiber | Status of the Wound and Peri-wound Skin From Baseline to Last Visit: Malodour | Equal/Unchanged | 8 Participants |
| Exufiber | Status of the Wound and Peri-wound Skin From Baseline to Last Visit: Malodour | Decrease | 0 Participants |
| Exufiber | Status of the Wound and Peri-wound Skin From Baseline to Last Visit: Malodour | Increase | 5 Participants |
| Aquacel® Ag Extra | Status of the Wound and Peri-wound Skin From Baseline to Last Visit: Malodour | Decrease | 0 Participants |
| Aquacel® Ag Extra | Status of the Wound and Peri-wound Skin From Baseline to Last Visit: Malodour | Increase | 3 Participants |
| Aquacel® Ag Extra | Status of the Wound and Peri-wound Skin From Baseline to Last Visit: Malodour | Equal/Unchanged | 9 Participants |
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.
Time frame: Total treatment period of 4 weeks (28 days)
Population: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Exufiber Ag + | Status of the Wound and Peri-wound Skin From Baseline to Last Visit: Redness/Irritation | Equal/Unchanged | 53 Participants |
| Exufiber Ag + | Status of the Wound and Peri-wound Skin From Baseline to Last Visit: Redness/Irritation | Decrease | 8 Participants |
| Exufiber Ag + | Status of the Wound and Peri-wound Skin From Baseline to Last Visit: Redness/Irritation | Increase | 0 Participants |
| Exufiber | Status of the Wound and Peri-wound Skin From Baseline to Last Visit: Redness/Irritation | Equal/Unchanged | 13 Participants |
| Exufiber | Status of the Wound and Peri-wound Skin From Baseline to Last Visit: Redness/Irritation | Decrease | 0 Participants |
| Exufiber | Status of the Wound and Peri-wound Skin From Baseline to Last Visit: Redness/Irritation | Increase | 0 Participants |
| Aquacel® Ag Extra | Status of the Wound and Peri-wound Skin From Baseline to Last Visit: Redness/Irritation | Decrease | 1 Participants |
| Aquacel® Ag Extra | Status of the Wound and Peri-wound Skin From Baseline to Last Visit: Redness/Irritation | Increase | 2 Participants |
| Aquacel® Ag Extra | Status of the Wound and Peri-wound Skin From Baseline to Last Visit: Redness/Irritation | Equal/Unchanged | 9 Participants |
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.
Time frame: Total treatment period of 4 weeks (28 days) or earlier if the wound is dry or healed
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Exufiber Ag + | Tissue Type of Wound Bed | Change in percent of epithelialisation | 11.4 change in percentage | Standard Deviation 29.2 |
| Exufiber Ag + | Tissue Type of Wound Bed | Change in percent of sloughy tissue | -6.48 change in percentage | Standard Deviation 28.2 |
| Exufiber Ag + | Tissue Type of Wound Bed | Change in percent of necrotic tissue | 2.13 change in percentage | Standard Deviation 14.73 |
| Exufiber Ag + | Tissue Type of Wound Bed | Change in percent of granulation tissue | -5.33 change in percentage | Standard Deviation 37.14 |
| Exufiber | Tissue Type of Wound Bed | Change in percent of necrotic tissue | 1.54 change in percentage | Standard Deviation 23.04 |
| Exufiber | Tissue Type of Wound Bed | Change in percent of epithelialisation | 13.8 change in percentage | Standard Deviation 29.6 |
| Exufiber | Tissue Type of Wound Bed | Change in percent of granulation tissue | -12.7 change in percentage | Standard Deviation 40.1 |
| Exufiber | Tissue Type of Wound Bed | Change in percent of sloughy tissue | -2.69 change in percentage | Standard Deviation 40.08 |
| Aquacel® Ag Extra | Tissue Type of Wound Bed | Change in percent of epithelialisation | 16.7 change in percentage | Standard Deviation 38.9 |
| Aquacel® Ag Extra | Tissue Type of Wound Bed | Change in percent of necrotic tissue | 2.5 change in percentage | Standard Deviation 8.66 |
| Aquacel® Ag Extra | Tissue Type of Wound Bed | Change in percent of sloughy tissue | -0.833 change in percentage | Standard Deviation 6.686 |
| Aquacel® Ag Extra | Tissue Type of Wound Bed | Change in percent of granulation tissue | -18.3 change in percentage | Standard Deviation 39.7 |
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.
Time frame: Total treatment period of 4 weeks (28 days) or earlier if the wound is dry or healed
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exufiber Ag + | Wound Area Reduction (mm^2) | -388.4 mm^2 | Standard Deviation 707.6 |
| Exufiber | Wound Area Reduction (mm^2) | -296.3 mm^2 | Standard Deviation 2567.7 |
| Aquacel® Ag Extra | Wound Area Reduction (mm^2) | -274.7 mm^2 | Standard Deviation 546.1 |