Evaluation of Exufiber Ag+ and Other Gelling Fibre Dressings

Not Applicable

Completed

Conditions: Wounds and Injuries

Interventions: Device: Exufiber Ag+
Device: Exufiber
Device: Aquacel Ag Extra

Registration Number: NCT03249909

Lead Sponsor: Molnlycke Health Care AB

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

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 109

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Aquacel® Ag Extra	Exufiber	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	Exufiber	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 +	Exufiber Ag+	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	Exufiber Ag+	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.
Aquacel® Ag Extra	Exufiber Ag+	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 +	Aquacel Ag Extra	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	Aquacel Ag Extra	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 +	Exufiber	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.
Aquacel® Ag Extra	Aquacel Ag Extra	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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: 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.
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.
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.
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: 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.

Trial Locations

Locations (8): Northwell Health
🇺🇸
Lake Success, New York, United States
Jobst Vascular Institue (JVI)
🇺🇸
Toledo, Ohio, United States
University of South Florida
🇺🇸
Tampa, Florida, United States
Boise VA Medical Center (Boise VAMC) M
🇺🇸
Boise, Idaho, United States
Center for Clinical Research, Inc.
🇺🇸
San Francisco, California, United States
University of Miami
🇺🇸
Miami, Florida, United States
Serena Group Research Institute
🇺🇸
Pittsburgh, Pennsylvania, United States
Midwestern University
🇺🇸
Glendale, Arizona, United States