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

Trial Summary

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.

What data supports the effectiveness of the treatment PluroGel for burns?

Research on similar synthetic and hydrogel burn dressings shows they can offer benefits like reduced dressing changes, better comfort, and effective bacterial control, which suggests PluroGel might have similar advantages. ^{1 2 3 4 5}

Is PluroGel safe for use in humans?

Hydrogel dressings, like PluroGel, have been used in various burn wound applications without any reported adverse events, and patients experienced no pain during dressing changes. ^{1 3 6 7 8}

How does PluroGel differ from standard dressings for burns?

PluroGel is a hydrogel dressing, which is unique because it can maintain moisture and potentially combine with other materials to enhance healing, unlike traditional dressings that may shrink when wet and lose integrity. This makes it a promising alternative for burn treatment, as it can help keep the wound environment stable and potentially improve healing outcomes. ^{1 2 9 10 11}

What is the purpose of this trial?

Burn injuries can result in long term physical and mental sequelae, not only from the scarring but also the painful dressings. The standard of care today remains use of antibiotic topical dressings while awaiting demarcation of the burn depth, with surgical excision and grafting for deep partial thickness and full thickness areas. Demarcation can be appreciated on admission for full thickness burns but is often a prolonged process that can last weeks. The clinical evaluation of the depth of the burn is a complex decision that often is made more challenging by the presence of the proteinaceous pseudoeschar and the coagulated dermis itself. Surgical debridement is relatively 'coarse' and by its very nature requires removal of a thin layer of viable tissue to reach the level that is vascularized enough to support a skin graft. There has been growing interest in the use of adjuncts to reduce the amount tissue debrided and potentially reduce the need for surgery itself. Operatively, there have been some reports that use of hydro-dissection devices (Versajet™) may allow a more controlled debridement, resulting in less viable tissue being sacrificed. There is also a growing experience with enzymatic debridement, especially with Bromolein, derived from Pineapple (NexoBrid®). Neither of these have been shown to definitively improve care in randomized controlled trials, (RCTs) and there is suggestion that in some settings may actually cause harm.

Eligibility Criteria

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

Burn depth full thickness or deeper on initial assessment

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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 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]

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]

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]

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]

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]

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]

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]

References

1. China pubmed.ncbi.nlm.nih.gov

[Progress in the studies on hydrogel burn dressings]. [2004]

2. England pubmed.ncbi.nlm.nih.gov

The use of a chitosan dressing with silver in the management of paediatric burn wounds: a pilot study. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Safety and efficacy of a new synthetic burn dressing: a multicenter study. [2019]

4. England 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. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Prospective clinical study of Hydron, a synthetic dressing, in delivery of an antimicrobial drug to second-degree burns. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

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

7. England pubmed.ncbi.nlm.nih.gov

Three donor site dressings in pediatric split-thickness skin grafts: study protocol for a randomised controlled trial. [2022]

8. India pubmed.ncbi.nlm.nih.gov

Biobrane dressing for paediatric burns in Singapore: a retrospective review. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

A clinical study of antimicrobial agents delivered to burn wounds from a drug-loaded synthetic dressing. [2019]

10. Canada pubmed.ncbi.nlm.nih.gov

Silver-coated nylon dressings for pediatric burn victims. [2021]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Comparison of the efficacy of silver-based antimicrobial burn dressings in a porcine model of burn wounds. [2021]