Evaluation of Exufiber Ag+ and Other Gelling Fibre Dressings

NCT03249909 | Completed Results FDA Device

• 1 other identifier: Exufiber Ag+ 01
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 8

Brief Summary

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

Conditions

Wounds and Injuries

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• 4-Week Wound Status

  At 4 weeks (28 days)

• Wound Area Reduction (mm^2)

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

• Frequency of Dressing Changes Between Visits

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

• Tissue Type of Wound Bed

  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

  Total treatment period of 4 weeks (28 days)

Study Arms (3)

Exufiber Ag +

OTHER

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+; Device: Exufiber; Device: Aquacel Ag Extra

Exufiber

OTHER

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+; Device: Exufiber; Device: Aquacel Ag Extra

Aquacel® Ag Extra

OTHER

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+; Device: Exufiber; Device: Aquacel Ag Extra

Interventions

Exufiber Ag+ DEVICE

gelling fibre dressing with silver

Aquacel® Ag Extra; Exufiber; Exufiber Ag +

Exufiber DEVICE

gelling fibre without silver

Aquacel® Ag Extra; Exufiber; Exufiber Ag +

Aquacel Ag Extra DEVICE

gelling fibre with silver

Aquacel® Ag Extra; Exufiber; Exufiber Ag +

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed Informed Consent Form
• Both gender ≥ 18 years old
• From Medium to High exuding wound

You may not qualify if:

• 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
• Involvement in the planning and conduct of the clinical investigation

Sponsors & Collaborators

• Molnlycke Health Care AB: lead

Study Sites (8)

Midwestern University

Glendale, Arizona, 85308, United States

Location

Center for Clinical Research, Inc.

San Francisco, California, 94115, United States

Location

University of Miami

Miami, Florida, 33125, United States

Location

University of South Florida

Tampa, Florida, 33606, United States

Location

Boise VA Medical Center (Boise VAMC) M

Boise, Idaho, 83702, United States

Location

Northwell Health

Lake Success, New York, 11042, United States

Location

Jobst Vascular Institue (JVI)

Toledo, Ohio, 43606, United States

Location

Serena Group Research Institute

Pittsburgh, Pennsylvania, 15222, United States

Location

MeSH Terms

Conditions

Wounds and Injuries

Limitations and Caveats

This clinical investigation was limited in that it was non-comparative and based on a limited number of subjects.

Results Point of Contact

• Title: Andrea Marie Picchietti
• Organization: Mölnlycke Health Care

andrea.picchietti@molnlycke.com

260 2583879

Study Officials

• Hadar Lev-Tov, MD, MAS

  University of Miami

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Open Label
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 6, 2017
• First Posted: August 15, 2017
• Study Start: August 11, 2017
• Primary Completion: August 19, 2019
• Study Completion: August 19, 2019
• Last Updated: September 29, 2020
• Results First Posted: September 29, 2020

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)