Evaluation of Exufiber Ag+ and Other Gelling Fibre Dressings

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.

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.

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 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.

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.

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.

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.

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 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 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.