Clinical trial NCT04839523: Performance and Safety of Exufiber Ag+ and Exufiber on Partial Thickness Burns
Official title: An Open, Non-comparative, Multi-center Investigation to Evaluate Performance and Safety of Exufiber Ag+ and Exufiber on Partial Thickness Burns
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Partial-thickness Burn
Lead sponsor: Molnlycke Health Care AB
Sponsor class: INDUSTRY
First posted: 2021-04-09
Enrollment: 44
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Wound progression
timeFrame: 5 weeks
Secondary outcomes:
measure: Time to discontinuation of study dressings
timeFrame: 5 weeks
measure: Wound Size
timeFrame: 5 weeks
measure: Re-epithelialization of wound
timeFrame: 5 weeks
measure: Wound Exudate
timeFrame: 5 weeks
measure: Wound Maceration
timeFrame: 5 weeks
measure: Proportion of Burn Healed
timeFrame: 5 weeks
measure: Blistering
timeFrame: 5 weeks
measure: Wound Redness/Irritation peri-wound skin
timeFrame: 5 weeks
measure: Exudate Nature
timeFrame: 5 weeks
measure: Malodor
timeFrame: 5 weeks
measure: Burn odor
timeFrame: 5 weeks
measure: Local infection
timeFrame: 5 weeks
measure: Subject pain
timeFrame: 5 weeks
measure: Dressing Adherence
timeFrame: 5 weeks
measure: Rewetting
timeFrame: 5 weeks
measure: Dressing ability to rehydrate
timeFrame: 5 weeks
measure: Dressing ability to retain exudate
timeFrame: 5 weeks
measure: Dressing ability to absorb blood
timeFrame: 5 weeks
measure: Dressing ability to retain slough
timeFrame: 5 weeks
measure: Dressing ability to clean wound bed
timeFrame: 5 weeks
measure: Dressing ability to retain gelling properties
timeFrame: 5 weeks
measure: Dressing ability to retain balanced moist environment
timeFrame: 5 weeks
measure: Dressing conformability
timeFrame: 5 weeks
measure: Dressing flexibility
timeFrame: 5 weeks
measure: Ease of dressing application
timeFrame: 5 weeks
measure: Ease of dressing removal with and without moistening
timeFrame: 5 weeks
measure: Dressing removal in one piece
timeFrame: 5 weeks
measure: Residuals of dressing material in the wound or surrounding skin
timeFrame: 5 weeks
measure: Bleeding at removal
timeFrame: 5 weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Burn Center, Valleywise Health
state: Arizona
city: Los Angeles
country: United States
facility: Keck Medical Center of USC
state: California
city: Washington
country: United States
facility: MedStar Health Research Institute
state: District of Columbia
city: Tampa
country: United States
facility: University of South Florida-Tampa General Hospital
state: Florida
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Philadelphia
country: United States
facility: Drexel Univerisity
state: Pennsylvania
Study officials:
References: