PluroGel vs Standard Dressing for Burns

Overseen By Justin Gawaziuk

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)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for burn injuries using a gel called PluroGel. Researchers aim to determine if PluroGel, when combined with a standard dressing, heals burns more effectively than the standard dressing alone. They hope this treatment will reduce the need for surgery and make the healing process less painful. Individuals with partial thickness burns on both arms or legs might be suitable for this trial. As a Phase 1 and Phase 2 trial, this research focuses on understanding how the treatment works in people and measuring its effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking advancements in burn treatment.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

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

Research has shown that PluroGel has been used to treat burn wounds without any reported side effects. Studies have found that it dissolves completely in water and is safe for the body, allowing it to work effectively without causing harm. PluroGel keeps the wound moist, aiding in the healing process, which makes it a good choice for treating burns.

As the treatment is relatively new, ongoing studies are important to confirm its safety. However, no evidence currently suggests it causes problems for patients. Prospective trial participants can feel reassured by these findings, but discussing any concerns with medical professionals is always advisable. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

PluroGel is unique because it combines a gel with a moistened gauze, potentially enhancing healing for burn wounds. Unlike standard burn treatments, which typically involve topical antibiotics and dry gauze, PluroGel maintains a moist environment that can promote faster and more effective healing. Researchers are excited about its potential to improve patient outcomes by offering a new way to care for burns that might reduce healing time and improve comfort.

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

Research has shown that PluroGel, which participants in this trial may receive, can enhance wound healing. It maintains moisture and protection, potentially accelerating the healing process. For wounds such as venous leg ulcers, PluroGel has proven effective in promoting healing. It aids the body in naturally breaking down dead tissue, a process known as autolytic debridement. This makes it a promising treatment for burns, as it may improve healing by stabilizing the wound. Meanwhile, the standard dressing, another treatment option in this trial, will serve as a comparator to evaluate PluroGel's effectiveness. ^{2 3 5 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals with partial thickness burns on both limbs that need hospital admission. It's not for those with more than 30% of their body burned, full-thickness burns at first check, previous burn treatment elsewhere, malnutrition before the injury, or burns from electricity or chemicals.

Inclusion Criteria

I have burns on both limbs that need hospital care.

Exclusion Criteria

Over 30% of my body is burned.

Patients with electrical, chemical or other unusual burn etiologies

I had surgery at a different hospital.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

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

2 weeks

Visits 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 potential new treatment for burn injuries, to standard antibiotic dressings. The goal is to see if PluroGel® can reduce pain and improve healing without needing as much 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).

Standard dressing is already approved in United States, European Union for the following indications:

Approved in United States as Standard Wound Dressing for:

• General wound care
• Burn injuries
• Surgical wounds

Approved in European Union as Conventional Wound Dressing for:

• General wound care
• Burn injuries
• Surgical wounds

Who Is Running the Clinical Trial?

University of Manitoba

Lead Sponsor

Trials

628

Recruited

209,000+

Published Research Related to This Trial

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]

The study involved 33 patients with second- and third-degree burn wounds, where antimicrobial agents were released from synthetic dressings made of PEG and PHEMA, effectively covering large areas of the wounds for 3 days.

These drug-loaded dressings not only provided antimicrobial protection but also reduced nursing workload and patient discomfort, highlighting their practical benefits in burn care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A clinical study of antimicrobial agents delivered to burn wounds from a drug-loaded synthetic dressing. Nathan, P., Robb, EC., Law, EJ., et al.[2019]

The new synthetic dressing for burn injuries was found to provide greater patient comfort and equivalent bacterial control compared to conventional treatments, along with less frequent dressing changes and potentially faster healing.

However, it has some drawbacks, such as difficulty in application and poor adherence initially, and it is only recommended for superficial and moderate second-degree burns, not for third-degree burns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of a new synthetic burn dressing: a multicenter study. Curreri, PW., Desai, MH., Bartlett, RH., et al.[2019]

In a study of 15 pediatric burn patients, silver-coated nylon dressings were found to be effective, requiring an average of only 4.13 dressing changes and leading to quicker re-epithelialization of superficial wounds in about 13.9 days.

These dressings were also more cost-effective, saving $388 compared to traditional silver sulfadiazine cream, and they did not leave any residue on wounds, making them easier to manage at home.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Silver-coated nylon dressings for pediatric burn victims. Borsuk, DE., Gallant, M., Richard, D., et al.[2021]

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]

Hydrogel sheet dressings were successfully used to manage 50 burn wounds in 30 patients, showing ease of use and nonadherence during application, which contributed to patient comfort with no reported pain during dressing changes.

The clinical outcomes of using hydrogel dressings met or exceeded expectations, leading to the initiation of further studies to evaluate their efficacy and effectiveness in burn wound care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the use of hydrogel sheet dressings in comprehensive burn wound care. Burd, A.[2019]

Children with superficial partial thickness burns treated with Biobrane® dressing experienced a significantly shorter hospital stay (4.76 days) and a lower infection rate (0%) compared to those treated with conventional silver foam dressing (8.88 days and 35.3% infection rate).

Both dressing types showed no significant differences in long-term scar outcomes after an average follow-up of two years, indicating that while Biobrane may improve short-term recovery, it does not affect long-term healing compared to silver foam.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biobrane dressing for paediatric burns in Singapore: a retrospective review. Fan, C., Pek, CH., Por, YC., et al.[2018]

This study is a randomized trial comparing three different donor site dressings for pediatric skin grafts, aiming to determine which dressing leads to the fastest healing and least pain for children, with a focus on real-world applicability.

The outcomes will include not only healing time and pain but also long-term effects like scar appearance and dressing costs, providing comprehensive data to guide future dressing choices in pediatric burn care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Three donor site dressings in pediatric split-thickness skin grafts: study protocol for a randomised controlled trial. McBride, CA., Kimble, RM., Stockton, K.[2022]

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]

In a study involving 72 pediatric patients with acute thermal burns, there was no significant difference in pain relief between Burnaid hydrogel dressing and plasticised polyvinylchloride film, indicating that neither dressing provided a clear analgesic advantage.

The trial, conducted over one year, showed that both dressings resulted in similar pain scores, stress levels, and re-epithelialisation rates, suggesting that Burnaid hydrogel dressing may not be a more effective option for pain management in pediatric burn treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a hydrogel dressing as an analgesic adjunct to first aid for the treatment of acute paediatric burn injuries: a prospective randomised controlled trial. Holbert, MD., Kimble, RM., Chatfield, M., et al.[2021]

In a clinical trial involving 27 patients with second-degree burns, a synthetic dressing (Hydron-AgSD) demonstrated a significant reduction in the need for dressing changes compared to standard silver sulfadiazine treatment, enhancing patient comfort.

The synthetic dressing effectively prevented bacterial contamination in most cases, while healing rates were similar to those of traditional dressings, suggesting it may offer both safety and efficacy in managing burn wounds.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective clinical study of Hydron, a synthetic dressing, in delivery of an antimicrobial drug to second-degree burns. Fang, CH., Nathan, P., Robb, EC., et al.[2019]

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/skin-health/plurogel/

PluroGel® Burn and Wound Dressing Two side-by-side wounds to show healing progress after 10 days of PluroGel. Three side-by-side wounds to show weekly healing status over three ...