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Evaluation of Exufiber Ag+ and Other Gelling Fibre Dressings

Primary Purpose

Wounds and Injuries

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exufiber Ag+
Exufiber
Aquacel Ag Extra
Sponsored by
Molnlycke Health Care AB
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wounds and Injuries

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Midwestern University
  • Center for Clinical Research, Inc.
  • University of Miami
  • University of South Florida
  • Boise VA Medical Center (Boise VAMC) M
  • Northwell Health
  • Jobst Vascular Institue (JVI)
  • Serena Group Research Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

Exufiber Ag +

Exufiber

Aquacel® Ag Extra

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
August 6, 2017
Last Updated
September 8, 2020
Sponsor
Molnlycke Health Care AB
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1. Study Identification

Unique Protocol Identification Number
NCT03249909
Brief Title
Evaluation of Exufiber Ag+ and Other Gelling Fibre Dressings
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
August 11, 2017 (Actual)
Primary Completion Date
August 19, 2019 (Actual)
Study Completion Date
August 19, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Molnlycke Health Care AB

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wounds and Injuries

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Masking Description
Open Label
Allocation
Non-Randomized
Enrollment
109 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exufiber Ag +
Arm Type
Other
Arm Description
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.
Arm Title
Exufiber
Arm Type
Other
Arm Description
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.
Arm Title
Aquacel® Ag Extra
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Exufiber Ag+
Intervention Description
gelling fibre dressing with silver
Intervention Type
Device
Intervention Name(s)
Exufiber
Intervention Description
gelling fibre without silver
Intervention Type
Device
Intervention Name(s)
Aquacel Ag Extra
Intervention Description
gelling fibre with silver
Primary Outcome Measure Information:
Title
Change in Exudate Status From Baseline to Last Visit
Description
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.
Time Frame
4 weeks (28 days) or earlier if the wound is dry or healed
Secondary Outcome Measure Information:
Title
4-Week Wound Status
Description
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.
Time Frame
At 4 weeks (28 days)
Title
Wound Area Reduction (mm^2)
Description
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.
Time Frame
Total treatment period of 4 weeks (28 days) or earlier if the wound is dry or healed
Title
Frequency of Dressing Changes Between Visits
Description
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.
Time Frame
Total treatment period of 4 weeks (28 days) or earlier if the wound is dry or healed
Title
Tissue Type of Wound Bed
Description
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.
Time Frame
Total treatment period of 4 weeks (28 days) or earlier if the wound is dry or healed
Title
Status of the Wound and Peri-wound Skin From Baseline to Last Visit: Malodour
Description
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.
Time Frame
Total treatment period of 4 weeks (28 days)
Title
Status of the Wound and Peri-wound Skin From Baseline to Last Visit: Redness/Irritation
Description
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.
Time Frame
Total treatment period of 4 weeks (28 days)
Title
Status of the Wound and Peri-wound Skin From Baseline to Last Visit: Maceration
Description
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.
Time Frame
Total treatment period of 4 weeks (28 days)
Title
Handling and Technical Performance of the Dressing
Description
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.
Time Frame
At 4 weeks (28 days)
Title
Comfort, Conformability, and Acceptability of the Dressings by Subject
Description
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.
Time Frame
At 4 weeks (28 days) or earlier if the wound is dry or healed

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hadar Lev-Tov, MD, MAS
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
Midwestern University
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85308
Country
United States
Facility Name
Center for Clinical Research, Inc.
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Boise VA Medical Center (Boise VAMC) M
City
Boise
State/Province
Idaho
ZIP/Postal Code
83702
Country
United States
Facility Name
Northwell Health
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Jobst Vascular Institue (JVI)
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
Country
United States
Facility Name
Serena Group Research Institute
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15222
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Evaluation of Exufiber Ag+ and Other Gelling Fibre Dressings

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