Evaluation of Exufiber Ag+ and Other Gelling Fibre Dressings

N/ACompletedNCT03249909

Molnlycke Health Care AB109 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

109

Conditions

Wounds and Injuries

Interventions

Exufiber Ag+DEVICE

gelling fibre dressing with silver

ExufiberDEVICE

gelling fibre without silver

Aquacel Ag ExtraDEVICE

gelling fibre with silver

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (8)

Midwestern University

Glendale, Arizona, United States

Center for Clinical Research, Inc.

San Francisco, California, United States

University of Miami

Miami, Florida, United States

University of South Florida

Tampa, Florida, United States

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

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.

Time frame: 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.

Data from ClinicalTrials.gov

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Boise VA Medical Center (Boise VAMC) M

Boise, Idaho, United States

Northwell Health

Lake Success, New York, United States

Jobst Vascular Institue (JVI)

Toledo, Ohio, United States

Serena Group Research Institute

Pittsburgh, Pennsylvania, United States

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: At 4 weeks (28 days) or earlier if the wound is dry or healed