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

NCT ID: NCT04839523

Last Updated: 2024-11-12

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-10
• Study Completion Date: 2024-12-31

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.

Detailed Description

This is a multi-center study taking place in the United States, and conducted at 3-4 sites/locations. It is designed as an open, non-comparative study to test the safety and performance of Exufiber Ag+ and Exufiber in managing burn healing.

The primary objective of this study is to evaluate the clinical safety and performance of all study 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. The dressings are intended to promote healing through the management of the wound environment.

Sixty-eight (68) subjects with partial thickness burns will be treated with either Exufiber Ag+ (34 subjects) or Exufiber (34 subjects) primary dressings, at the discretion of the Investigator. Secondary dressings should be non-adherent, non-antimicrobial dressings (local treatment praxis).

Each Subject will be evaluated at five (5) planned study visits for a maximum total treatment period of up to 21 days, unless the burn heals.

Visit 1 is a baseline visit to enroll Subjects and determine burn extent. Each Subject will be assigned to either Exufiber Ag+ or Exufiber primary dressings and treated according to the Instructions for Use (IFU) and the local clinical routine.

Visit 2 is a Confirmation Visit at up to 3 days, where the Investigator will confirm the burn meets study eligibility, and has not progressed to a full-thickness burn.

Visits 3, 4, and 5 are follow-up visits at days 7, 14, and 21, respectively, from the date of the primary dressing application.

At each follow-up visit the Subject will return to the clinic for evaluation and primary dressing change. Wound progression will be determined by the Investigator at each study visit and measured by three outcome variables (Deteriorated, No Change, Improved). Images of the wound at each follow up visit will be analyzed to determine changes in wound size.

Secondary endpoints will be collected identically at each visit at each clinical site to assess safety and performance of the dressings. The secondary objectives are:

• To evaluate time to discontinuation of study dressings from baseline to the last clinical follow-up visit, up to 21 days.
• To evaluate clinical outcomes of the study wound from baseline to the last clinical visit up to 21 days.
• To evaluate epithelization from baseline to the last clinical follow-up visit up to 21 days based on digital photo imaging software measurements.
• To evaluate a change in wound size from baseline to the last clinical follow-up visit up to 21 days based on digital photo and imaging software measurements.
• To evaluate healing status, including exudate levels, infection status, and proportion of burn healed, by clinician's visual judgement, at Confirmation Visit (up to 72 hours) and at each clinic follow-up visit, up to 21 days.
• To evaluate Subject-reported pain at application, during wear, and at dressing changes through questionnaires at each clinic follow-up visit up to 21 days.
• To evaluate treatment and dressing selections, including type and quantity, at application and at each clinic follow-up visit up to 21 days.
• To evaluate clinician handling of the dressing at application and at every dressing change performed at the clinic, from baseline and at each follow-up visit up to 21 days.
• To evaluate clinician assessment of the dressing at application and at every dressing change performed at the clinic, from baseline and at each follow-up visit up to 21 days.

Conditions

Partial-thickness Burn

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Exufiber

Treatment with Exufiber gelling fiber dressing

Group Type: EXPERIMENTAL

Exufiber

Intervention Type: DEVICE

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

Exufiber Ag+

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

Group Type: EXPERIMENTAL

Exufiber Ag+

Intervention Type: DEVICE

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

Interventions

Exufiber

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

Intervention Type: DEVICE

Exufiber Ag+

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Signed informed consent

2. Burn of thermal origin

3. Patients presenting with partial thickness burns covering < 5% TBSA for study treatment

4. TBSA covered with any burn type is ≤15%, with a maximum of 10% being full thickness burns

5. Clean wounds with ≤10% necrotic tissue

6. Patients presenting with moderate to high exuding wounds

7. Serous or Serosanguinous exudate

8. Patient is not contraindicated for the dressing to which he/she is assigned

Exclusion Criteria

1. Electrical Burns

2. Chemical Burns including acidic or basic sources

3. Ionizing radiation injuries

4. Dry wounds

5. Neonates

6. Patients with delayed presentation for burn care (>72 hours from time of injury)

7. Before entry into the study, treatment to the study wound included an active agent that would confound study results, as determined by the Investigator

8. Burns under study treatment transitioning to full thickness, or deep partial thickness burns requiring surgical treatment

9. Clinically infected burn

10. Patients with insulin dependent diabetes mellitus

11. Patients treated with systemic glucocorticosteroids, except patients taking occasional doses or doses less than 10mg prednisolone per day or equivalent

12. Patients who have used immunosuppressive agents, radiation or chemotherapy within past 30 days

13. Known allergy/hypersensitivity to any of the components of the investigation products

14. History of comorbid conditions or diagnoses associated with higher risk of infection as determined by the Investigator

15. Diagnosed underlying disease(s) (e.g. HIV/AIDS, cancer, severe anemia)

16. Patients that are not expected to comply with the investigation due to physical and/or mental conditions

17. Pregnancy

18. Participation in other clinical investigation(s) within 1 month prior to start of the investigation

19. Previously enrolled in this investigation

• Minimum Eligible Age: 4 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Molnlycke Health Care AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Arizona Burn Center, Valleywise Health

Phoenix, Arizona, United States

Keck Medical Center of USC

Los Angeles, California, United States

MedStar Health Research Institute

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

University of South Florida-Tampa General Hospital

Tampa, Florida, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Drexel Univerisity

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

PTB01

Identifier Type: -

Identifier Source: org_study_id