PluroGel vs Standard Dressing for Burns

Overseen By Justin Gawaziuk, MSc

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: University of Manitoba

Disqualifiers: Tbsa >30%, Malnutrition, others

Stay on Your Current Meds You can continue your current medications while participating

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

Compensation: Varies

Number of Visits: Unknown

Duration: 1-14 days

25 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether PluroGel, an antimicrobial burn and wound dressing, is more effective than standard dressings for treating burn injuries. Researchers aim to determine if PluroGel can heal burns faster and with less pain than traditional methods, potentially reducing the need for surgery. The trial includes individuals with partial thickness burns on the face or a single limb who have been admitted to the hospital. Participants must not have burns covering more than 30% of their body or burns that are very deep initially. As a Phase 1, Phase 2 trial, this research focuses on understanding how PluroGel works in people and measuring its effectiveness in a smaller group, offering participants a chance to be among the first to benefit from this innovative treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

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

Research has shown that PluroGel is generally safe and well-tolerated. This water-based dressing helps keep wounds moist, supporting healing. Studies indicate it is safe for use on various burns, including first and second-degree burns. PluroGel is also used for other types of wounds, which suggests a good safety record. Although specific reports of negative effects are absent in the sources, its use for different wounds and burns suggests it is likely safe for people. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

PluroGel is unique because it combines a hydrophilic gel with a standard dressing to enhance healing for burn wounds. Unlike typical burn treatments that often rely solely on topical antibiotics and non-adherent dressings, PluroGel's hydrophilic nature helps keep the wound environment moist, which can accelerate healing. Researchers are excited about its potential to reduce infection and improve recovery times, offering a more effective alternative to traditional burn care options.

What evidence suggests that PluroGel could be an effective treatment for burns?

Research has shown that PluroGel, which participants in this trial may receive, may aid in treating burns by maintaining wound moisture. This supports healing and naturally breaks down dead tissue. One study found that PluroGel improved healing in leg ulcers, suggesting potential benefits for burn wounds as well. Additionally, PluroGel stabilizes the wound, which is crucial for preventing complications. Although data specifically on burns is limited, positive results in general wound healing make it a promising option. PluroGel's ability to hydrate and protect the wound is a key factor in its potential effectiveness. Meanwhile, the standard dressing, another treatment option in this trial, involves applying topical antibiotic ointment and non-adherent petrolatum fine-meshed gauze regularly. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for individuals with partial thickness burns on the face or one limb that require hospital admission. It's not suitable for those with full-thickness burns, electrical or chemical burns, malnutrition, previous excisions elsewhere, or if more than 30% of their body is burned.

Inclusion Criteria

I have burns on my face or one limb that needed hospital care.

Exclusion Criteria

Over 30% of my body has been burned.

I had surgery at a different hospital.

Patients with pre-existing malnutrition

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either PluroGel® or standard topical dressing for burn injuries

1-14 days

Dressing changes every Monday, Wednesday, and Friday

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• PluroGel
• Standard dressing

Trial Overview The study compares PluroGel®, a new type of burn dressing, to standard antibiotic dressings used in burn care. The goal is to see if PluroGel® can improve healing and reduce the need for surgical removal of damaged tissue.

How Is the Trial Designed?

Group I: Test dressing Experimental Treatment 1 Intervention

A 0.5 cm layer of PluroGel® followed by the above standard dressing. In addition, this will be covered with moistened gauze, kept moist twice daily. (The additional factors are the use of PluroGel® and moistened gauze. Standard dressing will continue to be used.)

Group II: Standard dressing Active Control 1 Intervention

Topical antibiotic ointment (Polysporin™ or formulary equivalent) and non-adherent petrolatum fine-meshed gauze (ADAPTIC™) applied every Monday, Wednesday and Friday (or equivalent).

PluroGel is already approved in United States for the following indications:

Approved in United States as PluroGel Burn and Wound Dressing for:

• Management of full and partial thickness wounds including surgically created wounds, dermal ulcers (pressure ulcers), leg ulcers (diabetic foot ulcers), superficial wounds, first degree burns, partial thickness burns, and donor sites.
• Minor cuts, minor burns, and minor lacerations (OTC)

Who Is Running the Clinical Trial?

University of Manitoba

Lead Sponsor

Trials

628

Recruited

209,000+

Medline Industries

Industry Sponsor

Trials

46

Recruited

23,000+

Published Research Related to This Trial

In an in vivo study using a porcine model, nanocrystalline silver dressings showed the most effective antimicrobial properties against common burn wound pathogens, significantly reducing microbial recovery compared to simple gauze.

While all tested silver-based dressings reduced swelling compared to gauze, only nanocrystalline silver demonstrated a statistically significant decrease in pathogen levels, suggesting it may be the best option for preventing infections in burn wounds.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the efficacy of silver-based antimicrobial burn dressings in a porcine model of burn wounds. Ross, JA., Allan, N., Olson, M., et al.[2021]

The AQUACEL Hydrofiber Dressing containing ionic silver demonstrated strong antimicrobial properties against a variety of burn wound pathogens, including antibiotic-resistant bacteria, during a 14-day test period.

This dressing not only helps prevent infection but also effectively manages fluid exudate, making it a valuable option for treating partial-thickness burns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Microbicidal properties of a silver-containing hydrofiber dressing against a variety of burn wound pathogens. Bowler, PG., Jones, SA., Walker, M., et al.[2022]

Topical antimicrobials are crucial in burn wound care as they help suppress microbial growth, which supports skin cell recovery and overall wound healing.

The review highlights four main classes of topical antiseptics—emulsifiers, acids, oxidizers, and heavy metals—discussing their mechanisms of action and the pros and cons of each in managing burn wounds.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Topical Antimicrobials in Burn Care: Part 1-Topical Antiseptics. Cambiaso-Daniel, J., Boukovalas, S., Bitz, GH., et al.[2020]

There is no significant difference in overall wound healing rates between non-antibacterial and antibacterial impregnated dressings, indicating that antibacterial properties may not enhance healing in this context.

Wounds treated with nitrofurazone dressings showed significantly lower levels of pathogenic bacteria, suggesting that while healing rates are similar, nitrofurazone may help reduce infection risk in burn wounds.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outpatient burns: a prospective study. Hunter, GR., Chang, FC.[2013]

Hydrogel burn dressings are highlighted as one of the most effective options for treating burns, showcasing their advantages when combined with other materials.

The review discusses the ongoing research and development trends in synthetic burn dressings, indicating a focus on improving their efficacy and safety for better patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Progress in the studies on hydrogel burn dressings]. Luo, J., Fang, G., Xie, X., et al.[2004]

Burn wounds have unique characteristics that differentiate them from other skin injuries, which necessitates specialized treatment approaches.

The paper reviews various types of burn dressings and compares their effectiveness against the ideal dressing criteria, highlighting the ongoing need for improved biomaterials in burn care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Principles of burn dressings. Quinn, KJ., Courtney, JM., Evans, JH., et al.[2019]

The chitosan-based silver dressing maintained its size and integrity when wet, unlike traditional burn dressings, which often shrink and disintegrate, making it a promising alternative for burn treatment.

In a pilot study involving 12 partial-thickness burns in 10 children, the wounds healed within an average of 8.3 days without any infections, indicating the dressing's efficacy and safety in managing burn wounds.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of a chitosan dressing with silver in the management of paediatric burn wounds: a pilot study. Massand, S., Cheema, F., Brown, S., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03275831

NCT03275831 | PluroGel on Wounds of Mixed Etiology A randomized controlled study (RCT) to investigate the topical effectiveness of PluroGel in healing venous and mixed aetiology leg ulcers.

2. thewoundpros.com thewoundpros.com/post/medline-plurogel-burn-and-wound-dressing

Medline Plurogel: Advanced Burn & Wound Dressing for ... Medline Plurogel stands out as an advanced wound dressing designed to create the ideal healing environment—one that hydrates, protects, and actively supports ...

3. withpower.com withpower.com/trial/phase-2-burns-9-2021-b7f8a

PluroGel vs Standard Dressing for Burns This makes it a promising alternative for burn treatment, as it can help keep the wound environment stable and potentially improve healing outcomes. Show more.

4. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf23/K233151.pdf

March 26, 2024 Medline Industries, LP Dinah Rincones Sr ... PluroGel® Antimicrobial Burn and. Wound Dressing maintains a moist wound and skin environment that supports autolytic debridement of necrotic ...

5. woundsource.com woundsource.com/sites/default/files/posters/sawc_efficacy_poster_5-5-19.pdf

EFFICACY OF AN INNOVATIVE WOUND CLEANSER AND ... The efficacy of AWC and AWG against immature and mature biofilms is expected to improve wound healing outcomes in chronic wounds. ... Medline PluroGel Burn and ...

6. woundsource.com woundsource.com/product/plurogel-burn-and-wound-dressing

PluroGel® Burn and Wound Dressing PluroGel Burn and Wound Dressing is 100% water soluble, bio-compatible, cell-friendly, and non-ionic. Aids in creating a moist wound healing environment.

7. medline.com medline.com/product/PluroGel-Burn-and-Wound-Dressing/Burn-Dressings/Z05-PF123057

PluroGel Burn and Wound Dressings Moistens the wound bed; Indicated for partial and full thickness wounds, dry to moderately draining wounds, and 1st and 2nd degree burns; Softer wound debris ...

8. eventscribe.net eventscribe.net/2023/includes/popups/expo/expoAssetTracking.asp?assetFP=VDYxQTlvWGtmeVhwbXF1SXRMVUlKY2VqeXlvdlJiWktjOXc5MlpuTWw3SjJvMUswYkdxL1ppSVg2cmpVVjRqeGNtaU9WdjAyeldjVE4veUI4Nk53em5pRFhjaDBySUdpbk8rTndlZERVeEFSWmU3dkJEdzVVcGpVb01ZUGpwaHV5MEpvZzU4VzVhWnMzWmViU3o4QzhQbGhMTE0vSVlxK1lRckhHYi9BTStaRjVKajZ6M2d5TllhYzV0Y2J2WW9EMzNiczdWWkFCRzg3RTNSSmhEbzBJaUUwUnNMUVpSYlpNQ05QZzlWYlNrSDlBT1NKRERsZlZ4ZGpIZlVOMlluRDIvZUZ3My9zN0d0OFNvekJSVDg4QVE9PQ==

PluroGel® PluroGel Burn and Wound Dressing is indicated for use on partial and full thickness lightly to moderately draining wounds, 1st and 2nd degree burns. Warnings ...

9. woundreference.com woundreference.com/p/product?id=plurogel-burn-and-wound-dressing-025-oz-tube-box-o

PluroGel Burn and Wound Dressing, 0.25 oz. Tube, b... PluroGel Burn and Wound Dressing is a concentrated, cell-friendly surfactant to aid in maintaining an optimal moist wound healing environment that promotes ...