Trial Outcomes & Findings for Evaluation of Exufiber Ag+ and Other Gelling Fibre Dressings (NCT NCT03249909)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

109 participants

Primary outcome timeframe

4 weeks (28 days) or earlier if the wound is dry or healed

Results posted on

2020-09-29

Participant Flow

Total enrolment was 109 subjects from 9 sites in the US, and was completed between 11 AUG 2017 and 12 JUN 2019.

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.

Participant milestones

Participant milestones
Measure	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.	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.	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.
Overall Study STARTED	78	15	16
Overall Study COMPLETED	72	14	16
Overall Study NOT COMPLETED	6	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Overall Study Withdrawal by Subject	3	0
Overall Study Adverse Event	3	0
Overall Study Lost to Follow-up	0	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Exufiber Ag+ n=78 Participants 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.	Exufiber n=15 Participants 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.	Aquacel Ag Extra n=16 Participants 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.	Total n=109 Participants Total of all reporting groups
Age, Continuous	63.5 years STANDARD_DEVIATION 13.9 • n=78 Participants	56.9 years STANDARD_DEVIATION 16.8 • n=15 Participants	56.6 years STANDARD_DEVIATION 11.5 • n=16 Participants	61.6 years STANDARD_DEVIATION 14.2 • n=109 Participants
Sex: Female, Male Female	29 Participants n=78 Participants	9 Participants n=15 Participants	4 Participants n=16 Participants	42 Participants n=109 Participants
Sex: Female, Male Male	49 Participants n=78 Participants	6 Participants n=15 Participants	12 Participants n=16 Participants	67 Participants n=109 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	78 participants n=78 Participants	15 participants n=15 Participants	16 participants n=16 Participants	109 participants n=109 Participants
Body Mass Index	32.9 kg/m^2 STANDARD_DEVIATION 8.8 • n=78 Participants	35.8 kg/m^2 STANDARD_DEVIATION 11.2 • n=15 Participants	35.8 kg/m^2 STANDARD_DEVIATION 10.9 • n=16 Participants	33.7 kg/m^2 STANDARD_DEVIATION 9.5 • n=109 Participants

PRIMARY outcome

Timeframe: 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)

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.

Outcome measures

Outcome measures
Measure	Exufiber Ag + n=75 Participants 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	Exufiber n=14 Participants 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	Aquacel® Ag Extra n=16 Participants 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
Change in Exudate Status From Baseline to Last Visit Decreased exudate status	27 Participants	3 Participants	7 Participants
Change in Exudate Status From Baseline to Last Visit Unchanged exudate status	40 Participants	6 Participants	8 Participants
Change in Exudate Status From Baseline to Last Visit Increased exudate status	8 Participants	5 Participants	1 Participants

SECONDARY outcome

Timeframe: 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)

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.

Outcome measures

Outcome measures
Measure	Exufiber Ag + n=60 Participants 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	Exufiber n=13 Participants 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	Aquacel® Ag Extra n=12 Participants 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
4-Week Wound Status Stagnated	2 Participants	1 Participants	1 Participants
4-Week Wound Status Aggravated	5 Participants	3 Participants	0 Participants
4-Week Wound Status Sames as baseline	1 Participants	1 Participants	3 Participants
4-Week Wound Status Improved	48 Participants	7 Participants	6 Participants
4-Week Wound Status Healed	4 Participants	1 Participants	2 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Exufiber Ag + n=59 Participants 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	Exufiber n=13 Participants 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	Aquacel® Ag Extra n=12 Participants 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
Wound Area Reduction (mm^2)	-388.4 mm^2 Standard Deviation 707.6	-296.3 mm^2 Standard Deviation 2567.7	-274.7 mm^2 Standard Deviation 546.1

SECONDARY outcome

Timeframe: Total treatment period of 4 weeks (28 days) or earlier if the wound is dry or healed

Population: Intent to Treat population

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.

Outcome measures

Outcome measures
Measure	Exufiber Ag + n=78 Participants 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	Exufiber n=15 Participants 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	Aquacel® Ag Extra n=16 Participants 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
Frequency of Dressing Changes Between Visits	1.36 dressing changes / 7 days Standard Deviation 1.77	0.511 dressing changes / 7 days Standard Deviation 0.633	3.56 dressing changes / 7 days Standard Deviation 1.56

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Exufiber Ag + n=61 Participants 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	Exufiber n=13 Participants 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	Aquacel® Ag Extra n=12 Participants 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
Tissue Type of Wound Bed Change in percent of necrotic tissue	2.13 change in percentage Standard Deviation 14.73	1.54 change in percentage Standard Deviation 23.04	2.5 change in percentage Standard Deviation 8.66
Tissue Type of Wound Bed Change in percent of sloughy tissue	-6.48 change in percentage Standard Deviation 28.20	-2.69 change in percentage Standard Deviation 40.08	-0.833 change in percentage Standard Deviation 6.686
Tissue Type of Wound Bed Change in percent of granulation tissue	-5.33 change in percentage Standard Deviation 37.14	-12.7 change in percentage Standard Deviation 40.1	-18.3 change in percentage Standard Deviation 39.7
Tissue Type of Wound Bed Change in percent of epithelialisation	11.4 change in percentage Standard Deviation 29.2	13.8 change in percentage Standard Deviation 29.6	16.7 change in percentage Standard Deviation 38.9

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Exufiber Ag + n=61 Participants 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	Exufiber n=13 Participants 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	Aquacel® Ag Extra n=12 Participants 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
Status of the Wound and Peri-wound Skin From Baseline to Last Visit: Malodour Decrease	3 Participants	0 Participants	0 Participants
Status of the Wound and Peri-wound Skin From Baseline to Last Visit: Malodour Equal/Unchanged	45 Participants	8 Participants	9 Participants
Status of the Wound and Peri-wound Skin From Baseline to Last Visit: Malodour Increase	13 Participants	5 Participants	3 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Exufiber Ag + n=61 Participants 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	Exufiber n=13 Participants 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	Aquacel® Ag Extra n=12 Participants 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
Status of the Wound and Peri-wound Skin From Baseline to Last Visit: Redness/Irritation Decrease	8 Participants	0 Participants	1 Participants
Status of the Wound and Peri-wound Skin From Baseline to Last Visit: Redness/Irritation Equal/Unchanged	53 Participants	13 Participants	9 Participants
Status of the Wound and Peri-wound Skin From Baseline to Last Visit: Redness/Irritation Increase	0 Participants	0 Participants	2 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Exufiber Ag + n=61 Participants 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	Exufiber n=13 Participants 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	Aquacel® Ag Extra n=12 Participants 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
Status of the Wound and Peri-wound Skin From Baseline to Last Visit: Maceration Increase	6 Participants	0 Participants	0 Participants
Status of the Wound and Peri-wound Skin From Baseline to Last Visit: Maceration Decrease	16 Participants	0 Participants	5 Participants
Status of the Wound and Peri-wound Skin From Baseline to Last Visit: Maceration Equal/Unchanged	39 Participants	13 Participants	7 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Exufiber Ag + n=63 Participants 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	Exufiber n=15 Participants 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	Aquacel® Ag Extra n=16 Participants 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
Handling and Technical Performance of the Dressing Ease of application of dressing	57.8 % of subjects	100.0 % of subjects	66.7 % of subjects
Handling and Technical Performance of the Dressing Ease of removal of dressing without moistening	56.4 % of subjects	85.7 % of subjects	63.6 % of subjects
Handling and Technical Performance of the Dressing Removal in one piece	64.3 % of subjects	92.9 % of subjects	63.6 % of subjects
Handling and Technical Performance of the Dressing Ability to absorb exudate	55.4 % of subjects	92.9 % of subjects	55.6 % of subjects
Handling and Technical Performance of the Dressing Ability to absorb blood	59.2 % of subjects	92.9 % of subjects	55.6 % of subjects
Handling and Technical Performance of the Dressing Ability to retain exudate	60.7 % of subjects	92.9 % of subjects	55.6 % of subjects
Handling and Technical Performance of the Dressing Ability to retain slough	55.6 % of subjects	92.9 % of subjects	55.6 % of subjects
Handling and Technical Performance of the Dressing Ability to clean wound bed	49.2 % of subjects	92.9 % of subjects	44.4 % of subjects
Handling and Technical Performance of the Dressing Ability to retain balanced moist environment	50.0 % of subjects	92.9 % of subjects	55.6 % of subjects
Handling and Technical Performance of the Dressing Conformability to wound	48.3 % of subjects	92.9 % of subjects	60.0 % of subjects
Handling and Technical Performance of the Dressing Overall experience	51.7 % of subjects	92.9 % of subjects	60.0 % of subjects

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Exufiber Ag + n=63 Participants 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	Exufiber n=15 Participants 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	Aquacel® Ag Extra n=16 Participants 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
Comfort, Conformability, and Acceptability of the Dressings by Subject Comfort while wearing	44.3 % of subjects	57.1 % of subjects	66.7 % of subjects
Comfort, Conformability, and Acceptability of the Dressings by Subject Ease of mobility	41.0 % of subjects	64.3 % of subjects	66.7 % of subjects
Comfort, Conformability, and Acceptability of the Dressings by Subject Primary dressing remained in place	49.2 % of subjects	64.3 % of subjects	58.3 % of subjects
Comfort, Conformability, and Acceptability of the Dressings by Subject No stinging or burning	87.5 % of subjects	85.7 % of subjects	100.0 % of subjects
Comfort, Conformability, and Acceptability of the Dressings by Subject Overall experience	45.6 % of subjects	64.3 % of subjects	63.6 % of subjects

Adverse Events

Exufiber Ag+

Serious events: 7 serious events

Other events: 14 other events

Deaths: 0 deaths

Exufiber

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Aquacel Ag Extra

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Exufiber Ag+ n=78 participants at risk 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.	Exufiber n=15 participants at risk 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.	Aquacel Ag Extra n=16 participants at risk 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.
Nervous system disorders Syncope	1.3% 1/78 • Number of events 1 • 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.	0.00% 0/15 • 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.	0.00% 0/16 • 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.
Metabolism and nutrition disorders Arteriovenous fistula	1.3% 1/78 • Number of events 1 • 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.	0.00% 0/15 • 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.	0.00% 0/16 • 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.
Musculoskeletal and connective tissue disorders Revisional transmetatarsal amputation right foot	1.3% 1/78 • Number of events 1 • 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.	0.00% 0/15 • 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.	0.00% 0/16 • 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.
Skin and subcutaneous tissue disorders Infection on non-study foot	1.3% 1/78 • Number of events 1 • 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.	0.00% 0/15 • 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.	6.2% 1/16 • Number of events 1 • 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.
Respiratory, thoracic and mediastinal disorders Pneumonia	1.3% 1/78 • Number of events 1 • 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.	0.00% 0/15 • 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.	0.00% 0/16 • 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.
Renal and urinary disorders Kidney injury	1.3% 1/78 • Number of events 1 • 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.	0.00% 0/15 • 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.	0.00% 0/16 • 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.
Respiratory, thoracic and mediastinal disorders Shortness of breath	1.3% 1/78 • Number of events 1 • 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.	0.00% 0/15 • 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.	0.00% 0/16 • 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.
Infections and infestations Cellulitis	1.3% 1/78 • Number of events 1 • 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.	0.00% 0/15 • 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.	0.00% 0/16 • 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.
Metabolism and nutrition disorders Inability to eat	1.3% 1/78 • Number of events 1 • 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.	0.00% 0/15 • 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.	0.00% 0/16 • 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.

Other adverse events

Other adverse events
Measure	Exufiber Ag+ n=78 participants at risk 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.	Exufiber n=15 participants at risk 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.	Aquacel Ag Extra n=16 participants at risk 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.
Infections and infestations Cellulitis of non-study wound	1.3% 1/78 • Number of events 1 • 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.	13.3% 2/15 • Number of events 2 • 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.	0.00% 0/16 • 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.
Infections and infestations Cellulitis of study wound	0.00% 0/78 • 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.	13.3% 2/15 • Number of events 2 • 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.	0.00% 0/16 • 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.
General disorders Cold	1.3% 1/78 • Number of events 1 • 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.	0.00% 0/15 • 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.	0.00% 0/16 • 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.
Cardiac disorders Exacerbation of congestive heart failure	1.3% 1/78 • Number of events 1 • 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.	0.00% 0/15 • 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.	6.2% 1/16 • Number of events 1 • 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.
General disorders Fever	1.3% 1/78 • Number of events 1 • 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.	0.00% 0/15 • 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.	0.00% 0/16 • 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.
Infections and infestations Infection of the study wound	2.6% 2/78 • Number of events 2 • 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.	6.7% 1/15 • Number of events 2 • 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.	6.2% 1/16 • Number of events 1 • 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.
Skin and subcutaneous tissue disorders Itching of the non-study wound	1.3% 1/78 • Number of events 1 • 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.	0.00% 0/15 • 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.	0.00% 0/16 • 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.
Skin and subcutaneous tissue disorders Maceration in study wound	2.6% 2/78 • Number of events 2 • 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.	0.00% 0/15 • 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.	0.00% 0/16 • 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.
Gastrointestinal disorders Nausea	1.3% 1/78 • Number of events 1 • 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.	0.00% 0/15 • 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.	0.00% 0/16 • 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.
Skin and subcutaneous tissue disorders New ulcer	1.3% 1/78 • Number of events 1 • 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.	0.00% 0/15 • 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.	0.00% 0/16 • 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.
Musculoskeletal and connective tissue disorders Osteomyelitis	0.00% 0/78 • 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.	0.00% 0/15 • 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.	6.2% 1/16 • Number of events 1 • 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.
General disorders Pain in study wound	5.1% 4/78 • Number of events 4 • 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.	0.00% 0/15 • 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.	0.00% 0/16 • 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.
General disorders Pain not related to study wound	2.6% 2/78 • Number of events 2 • 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.	0.00% 0/15 • 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.	0.00% 0/16 • 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.
Cardiac disorders Peripheral artery disease	1.3% 1/78 • Number of events 1 • 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.	0.00% 0/15 • 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.	0.00% 0/16 • 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.

Additional Information

Andrea Marie Picchietti

Mölnlycke Health Care

Phone: 260 2583879

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place