PluroGel vs Standard Dressing for Burns
Trial Summary
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.
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.
What data supports the effectiveness of the treatment PluroGel for burns?
Research on hydrogel burn dressings, like PluroGel, shows they are effective in managing burns by combining with other materials to improve healing. Additionally, similar treatments with antimicrobial properties, such as silver-containing dressings, have been shown to prevent infection and aid in healing partial-thickness burns.12345
How does PluroGel differ from standard treatments for burns?
PluroGel is a hydrogel-based dressing that offers a moist environment for wound healing, which can be beneficial for burns. Unlike traditional dressings that may shrink or lose integrity when wet, hydrogels like PluroGel maintain their structure and can be combined with antimicrobial agents to prevent infection.23467
Eligibility Criteria
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either PluroGel® or standard topical dressing for burn injuries
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- PluroGel
- Standard dressing
PluroGel is already approved in United States for the following indications:
- 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)
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Manitoba
Lead Sponsor
Medline Industries
Industry Sponsor