drugset / Trial / NCT04893863

A Study of Plurogel® Compared to Standard Topical Dressing in Burn Injuries

NCT04893863

Phase 1/2 Recruiting 20 enrolled University of Manitoba
RandomizedParallel-groupDouble-blindTreatment

Summary

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.

Timeline

Start
2021-10-01
Primary completion
2028-12-31
Completion
2029-06-01

Drugs

EvaluationDrugModalityDoseRoute
Subject PluroGel Other / unclassified Topical
Comparator Polysporin Unknown Topical

Indications

No indication recorded.