Evaluation of Exufiber Ag+ and Other Gelling Fibre Dressings

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

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

Study Overview

• Status: Completed
• Conditions: Wounds and Injuries
• Intervention / Treatment: Device: Exufiber Ag+; Device: Exufiber; Device: Aquacel Ag Extra

• Study Type: Interventional
• Enrollment (Actual): 109
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Glendale, Arizona, United States, 85308
      • Midwestern University
  • California
    • San Francisco, California, United States, 94115
      • Center for Clinical Research, Inc.
  • Florida
    • Miami, Florida, United States, 33125
      • University of Miami
    • Tampa, Florida, United States, 33606
      • University of South Florida
  • Idaho
    • Boise, Idaho, United States, 83702
      • Boise VA Medical Center (Boise VAMC) M
  • New York
    • Lake Success, New York, United States, 11042
      • Northwell Health
  • Ohio
    • Toledo, Ohio, United States, 43606
      • Jobst Vascular Institue (JVI)
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15222
      • Serena Group Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Device: Exufiber Ag+; gelling fibre dressing with silver; Device: Exufiber; gelling fibre without silver; Device: Aquacel Ag Extra; gelling fibre with silver
Other: 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.	Device: Exufiber Ag+; gelling fibre dressing with silver; Device: Exufiber; gelling fibre without silver; Device: Aquacel Ag Extra; gelling fibre with silver
Other: 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.	Device: Exufiber Ag+; gelling fibre dressing with silver; Device: Exufiber; gelling fibre without silver; Device: Aquacel Ag Extra; gelling fibre with silver

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	4 weeks (28 days) or earlier if the wound is dry or healed

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At 4 weeks (28 days)
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.	Total treatment period of 4 weeks (28 days) or earlier if the wound is dry or healed
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.	Total treatment period of 4 weeks (28 days) or earlier if the wound is dry or healed
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.	Total treatment period of 4 weeks (28 days) or earlier if the wound is dry or healed
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.	Total treatment period of 4 weeks (28 days)
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.	Total treatment period of 4 weeks (28 days)
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.	Total treatment period of 4 weeks (28 days)
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.	At 4 weeks (28 days)
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.	At 4 weeks (28 days) or earlier if the wound is dry or healed

Collaborators and Investigators

• Sponsor: Molnlycke Health Care AB
• Investigators: Principal Investigator: Hadar Lev-Tov, MD, MAS, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): August 11, 2017
• Primary Completion (Actual): August 19, 2019
• Study Completion (Actual): August 19, 2019

Study Registration Dates

• First Submitted: August 6, 2017
• First Submitted That Met QC Criteria: August 14, 2017
• First Posted (Actual): August 15, 2017

Study Record Updates

• Last Update Posted (Actual): September 29, 2020
• Last Update Submitted That Met QC Criteria: September 8, 2020
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Gastrointestinal Agents; Laxatives; Carboxymethylcellulose Sodium
• Other Study ID Numbers: Exufiber Ag+ 01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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