Performance and Safety of Exufiber Ag+ and Exufiber on Partial Thickness Burns

NCT04839523 | Active Not Recruiting FDA Device

• 1 other identifier: PTB01
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 6

Brief Summary

This a multi-center, open label, non-comparative, study that will evaluate the clinical safety and performance of Exufiber Ag+ and Exufiber dressings, separately, when used as intended in moderate to high exuding partial thickness burns (PTBs) through assessment of wound progression from baseline to the Subject's last clinical follow-up visit. Sixty-eight (68) eligible subjects, with moderate to high exuding partial-thickness burns, will be selected for treatment with either Exufiber Ag+ silver-coated gelling dressing, or Exufiber gelling dressing. The study will last 5 weeks, with a requirement of 5 study visits in total, including dressing changes at each study visit.

Conditions

Partial-thickness Burn

Outcome Measures

Primary Outcomes (1)

• Wound progression

  A subjective measurement to determine wound progression since the last visit, determined by three outcome variables: Deteriorated No Change Improved

  5 weeks

Secondary Outcomes (29)

• Time to discontinuation of study dressings

  5 weeks

• Wound Size

  5 weeks

• Re-epithelialization of wound

  5 weeks

• Wound Exudate

  5 weeks

• Wound Maceration

  5 weeks

Study Arms (2)

Exufiber

EXPERIMENTAL

Treatment with Exufiber gelling fiber dressing

Device: Exufiber

Exufiber Ag+

EXPERIMENTAL

Treatment with Exufiber Ag+ silver-coated, gelling fiber dressing

Device: Exufiber Ag+

Interventions

Exufiber DEVICE

A sterile nonwoven wound dressing made from highly absorbent PVA fibers.

Exufiber

Exufiber Ag+ DEVICE

A sterile nonwoven wound dressing made from highly absorbent PVA fibers, and coated with silver sulphate.

Exufiber Ag+

Eligibility Criteria

• Age: 4 Weeks+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent
• Burn of thermal origin
• Patients presenting with partial thickness burns covering \< 5% TBSA for study treatment
• TBSA covered with any burn type is ≤15%, with a maximum of 10% being full thickness burns
• Clean wounds with ≤10% necrotic tissue
• Patients presenting with moderate to high exuding wounds
• Serous or Serosanguinous exudate
• Patient is not contraindicated for the dressing to which he/she is assigned

You may not qualify if:

• Electrical Burns
• Chemical Burns including acidic or basic sources
• Ionizing radiation injuries
• Dry wounds
• Neonates
• Patients with delayed presentation for burn care (\>72 hours from time of injury)
• Before entry into the study, treatment to the study wound included an active agent that would confound study results, as determined by the Investigator
• Burns under study treatment transitioning to full thickness, or deep partial thickness burns requiring surgical treatment
• Clinically infected burn
• Patients with insulin dependent diabetes mellitus
• Patients treated with systemic glucocorticosteroids, except patients taking occasional doses or doses less than 10mg prednisolone per day or equivalent
• Patients who have used immunosuppressive agents, radiation or chemotherapy within past 30 days
• Known allergy/hypersensitivity to any of the components of the investigation products
• History of comorbid conditions or diagnoses associated with higher risk of infection as determined by the Investigator
• Diagnosed underlying disease(s) (e.g. HIV/AIDS, cancer, severe anemia)

Sponsors & Collaborators

• Molnlycke Health Care AB: lead

Study Sites (6)

Arizona Burn Center, Valleywise Health

Phoenix, Arizona, 85008, United States

Location

Keck Medical Center of USC

Los Angeles, California, 90033, United States

Location

MedStar Health Research Institute

Washington D.C., District of Columbia, 20010, United States

Location

University of South Florida-Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Drexel Univerisity

Philadelphia, Pennsylvania, 19102, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Wound size and tissue type will be assessed by a single, blinded, third-party clinician. The clinician will use imaging software to measure the size of the wound and identify tissue types, from baseline to last clinical follow-up.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2021
• First Posted: April 9, 2021
• Study Start: March 10, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: November 12, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)