Evaluation of Exufiber Ag+ and Other Gelling Fibre Dressings

• Exufiber Ag+ (Device): gelling fibre dressing with silver
• Exufiber (Device): gelling fibre without silver
• Aquacel Ag Extra (Device): gelling fibre with silver

Primary outcomes

• 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 outcomes

• 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.
• 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.
• 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.
• 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.

Sex: All, ages: 18 Years to any

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

Participant flow

Outcome results

• Change in Exudate Status From Baseline to Last Visit (Primary), Count of participants, Participants: Exufiber Ag + 27; Exufiber 3; Aquacel® Ag Extra 7 (p 0.0019)
• 4-Week Wound Status (Secondary), Count of participants, Participants: Exufiber Ag+ 2; Exufiber 1; Aquacel Ag Extra 1
• Wound Area Reduction (mm^2) (Secondary), Mean, mm^2: Exufiber Ag+ -388.4 +/- 707.6; Exufiber -296.3 +/- 2567.7; Aquacel Ag Extra -274.7 +/- 546.1
• Frequency of Dressing Changes Between Visits (Secondary), Mean, dressing changes / 7 days: Exufiber Ag+ 1.36 +/- 1.77; Exufiber 0.511 +/- 0.633; Aquacel Ag Extra 3.56 +/- 1.56
• Tissue Type of Wound Bed (Secondary), Mean, change in percentage: Exufiber Ag+ 2.13 +/- 14.73; Exufiber 1.54 +/- 23.04; Aquacel Ag Extra 2.5 +/- 8.66
• Status of the Wound and Peri-wound Skin From Baseline to Last Visit: Malodour (Secondary), Count of participants, Participants: Exufiber Ag+ 3; Exufiber 0; Aquacel Ag Extra 0
• Status of the Wound and Peri-wound Skin From Baseline to Last Visit: Redness/Irritation (Secondary), Count of participants, Participants: Exufiber Ag+ 8; Exufiber 0; Aquacel Ag Extra 1
• Status of the Wound and Peri-wound Skin From Baseline to Last Visit: Maceration (Secondary), Count of participants, Participants: Exufiber Ag+ 16; Exufiber 0; Aquacel Ag Extra 5
• Handling and Technical Performance of the Dressing (Secondary), Number, % of subjects: Exufiber Ag+ 57.8; Exufiber 100.0; Aquacel Ag Extra 66.7
• Comfort, Conformability, and Acceptability of the Dressings by Subject (Secondary), Number, % of subjects: Exufiber Ag+ 44.3; Exufiber 57.1; Aquacel Ag Extra 66.7

Adverse events

Time frame: All adverse event data were collected for a period of 2 years, throughout enrollment and follow-up of this study

Serious adverse events by term

Other adverse events by term

Limitations and caveats: This clinical investigation was limited in that it was non-comparative and based on a limited number of subjects.

• Study Protocol and Statistical Analysis Plan (PDF, 2019-02-19)
• Informed Consent Form (PDF, 2017-05-10)

• Hadar Lev-Tov, MD, MAS, Principal investigator, University of Miami