Exufiber Dressings for Burns

Not currently recruiting at 6 trial locations

Overseen By Jennifer O'Connell

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Molnlycke Health Care AB

Must not be taking: Immunosuppressants, Chemotherapy, Glucocorticosteroids

Disqualifiers: Diabetes, HIV/AIDS, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 9

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two types of dressings, Exufiber and Exufiber Ag+, to evaluate their effectiveness in healing burns that ooze significantly. The goal is to assess the safety and efficacy of these dressings on superficial burns. Individuals with burns covering less than 5% of their body and having clean, oozing wounds may qualify. Participants will attend five visits over five weeks to change dressings and monitor progress. As an unphased trial, this study provides participants the chance to contribute to valuable research that could enhance burn care for many.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are taking systemic glucocorticosteroids or have used immunosuppressive agents, radiation, or chemotherapy recently, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that Exufiber dressings are generally well-tolerated for treating wounds. They are used on various types of wounds that leak fluid, such as pressure sores and minor burns. The Exufiber dressing helps control moisture in the wound, which is important for healing. It is not suitable for dry wounds or very deep burns.

Exufiber Ag+ features a silver coating that fights bacteria, making it effective for wounds at risk of infection. Studies have shown it works well against different bacteria and fungi, helping to keep the wound clean as it heals.

Both Exufiber and Exufiber Ag+ are designed to be safe and effective for their intended uses. They have been used in medical settings for similar conditions and have demonstrated good safety records. However, if signs of infection appear or if the dressing dries out, consulting a healthcare professional is important. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Exufiber and Exufiber Ag+ are exciting new treatments for burns because they incorporate advanced gelling fiber technology to manage wound exudate efficiently. Unlike traditional dressings, which can stick to wounds and cause discomfort when changed, these dressings gel upon contact with fluid, creating a soothing environment that protects the wound. Exufiber Ag+ goes a step further by including a silver coating, which has antimicrobial properties to help prevent infection, a common concern with burn injuries. Researchers are particularly enthusiastic about how these features could improve healing times and patient comfort compared to standard dressings.

What evidence suggests that this trial's treatments could be effective for partial thickness burns?

Research has shown that Exufiber dressings, made from a plant-based material called cellulose, can speed up wound healing by maintaining moisture, which is crucial for recovery. In this trial, participants will receive either Exufiber or Exufiber Ag+ dressings. Exufiber Ag+ dressings contain silver, which kills germs and reduces bacteria in the wound, further aiding healing. This is particularly beneficial for burns that leak a lot of fluid. Both Exufiber and Exufiber Ag+ are designed to absorb and retain this fluid, promoting cleaner and faster healing. Overall, studies have found that these dressings can enhance wound healing. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for individuals with moderate to high exuding partial thickness burns covering less than 5% of their total body. They must have clean wounds, not be diabetic on insulin, and can't have used immunosuppressants or had certain treatments recently. Pregnant people and those unlikely to follow the study plan are excluded.

Inclusion Criteria

Less than 15% of my body is burned, with no more than 10% being severe burns.

Serous or Serosanguinous exudate

My burns cover less than 5% of my body.

Exclusion Criteria

My burn has worsened to needing surgery under the study treatment.

I am not on high doses of steroids, less than 10mg of prednisolone a day.

My wounds are dry.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Baseline and Treatment

Participants are enrolled, and treatment with Exufiber Ag+ or Exufiber dressings begins. Baseline measurements and initial dressing application occur.

3 weeks

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with evaluations and dressing changes at each visit.

2 weeks

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Exufiber
• Exufiber Ag+

Trial Overview The trial tests two types of dressings: Exufiber Ag+ (with silver) and regular Exufiber, on patients with partial thickness burns. It aims to see how well these dressings work over a period of 5 weeks with dressing changes at each visit.

How Is the Trial Designed?

Group I: Exufiber Ag+ Experimental Treatment 1 Intervention

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

Group II: Exufiber Experimental Treatment 1 Intervention

Treatment with Exufiber gelling fiber dressing

Who Is Running the Clinical Trial?

Molnlycke Health Care AB

Lead Sponsor

Trials

57

Recruited

7,900+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03249909?cond=ag%20in&viewType=Table&checkSpell=&rank=9

Evaluation of Exufiber Ag+ and Other Gelling Fibre Dressings Gelling fibre dressing without silver to treat chronic wounds, acute wounds, and pressure ulcers. Data from these groups were analyzed separately with no ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9210940/

Commercial wound dressings for the treatment of exuding ... The aim of this study was to determine several characteristics of a large variety of the most frequently used commercial wound dressings.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7951478/

A prospective, randomized trial of silver containing ... This study showed that Aquacel Ag increased time to healing, decreased pain symptoms and increased patient convenience.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0305417924003589

The efficacy of cellulose dressings in burn wound ... Cellulose based dressings showed a significantly faster healing time in comparison to control dressings. •. Patients with cellulose based dressings had a ...

5. withpower.com withpower.com/trial/phase-burns-2-2021-ebb61

Exufiber Dressings for Burns · Info for Participants This a multi-center, open label, non-comparative, study that will evaluate the clinical safety and performance of Exufiber Ag+ and Exufiber dressings, ...

6. molnlycke.us molnlycke.us/siteassets/master-and-local-markets/documents/master/wound-care-documents/non-mepilex-dressings/exufiber-product-sheet.pdf

Exufiber Product Sheet In case of signs of infection, consult a health care professional for infection treatment. Exufber is not intended for dry wounds or full thickness burns. If ...

7. molnlycke.us molnlycke.us/products-solutions/exufiber/

Exufiber - Gelling fiber dressing Exufiber can be used on a wide range of exuding wounds, including pressure ulcers, leg and foot ulcers, partial thickness burns, surgical wounds, donor sites, ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT04884568

Confirm Performance and Safety of Exufiber When Used as ... Exclusion Criteria: Burn injury of ≥20% of total body surface area. Diagnosed with paraplegia. Harvested graft from the same donor site location before.

9. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf16/K160379.pdf

August 25, 2016 Mölnlycke Health Care US, LLC Ms. Megan ... Exufiber Ag+ may be used for management of wounds as an effective barrier to bacterial penetration of the dressing, as this may help to reduce ...

10. fs.hubspotusercontent00.net fs.hubspotusercontent00.net/hubfs/4744308/Exufiber.pdf

Exufiber® Exufiber is not intended for dry wounds or full thickness burns. If the dressing dries out and is difficult to remove, it should be moistened according to ...