Evaluation of Exufiber Ag+ and Other Gelling Fibre Dressings

Study Overview
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Brief Summary
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Investigate impact of gelling fiber dressings on handling exudate in medium to high exuding wounds

Official Title
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A Clinical Investigation to Study the Effect of Exufiber Ag+ and Other Gelling Fibre Dressings on Wound Exudate and Bioburden in Medium to High Exuding Wounds

Conditions
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Wounds and Injuries

Intervention / Treatment
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* Device: Exufiber Ag+
* Device: Exufiber
* Device: Aquacel Ag Extra


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Exufiber Ag +<br>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. | Device: Exufiber Ag+<br>* gelling fibre dressing with silver<br>Device: Exufiber<br>* gelling fibre without silver<br>Device: Aquacel Ag Extra<br>* gelling fibre with silver<br>|
| Other: Exufiber<br>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. | Device: Exufiber Ag+<br>* gelling fibre dressing with silver<br>Device: Exufiber<br>* gelling fibre without silver<br>Device: Aquacel Ag Extra<br>* gelling fibre with silver<br>|
| Other: Aquacel® Ag Extra<br>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. | Device: Exufiber Ag+<br>* gelling fibre dressing with silver<br>Device: Exufiber<br>* gelling fibre without silver<br>Device: Aquacel Ag Extra<br>* gelling fibre with silver<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 |