RecruitingPhase 1Phase 2NCT04893863

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

A Within Patient, Pilot Randomized Controlled Study of Plurogel® Compared to Standard Topical Dressing in Burn Injuries


Sponsor

University of Manitoba

Enrollment

20 participants

Start Date

Oct 1, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria1

  • Persons with bilateral limb partial thickness burn injuries of similar depth requiring admission

Exclusion Criteria5

  • Total body surface area (TBSA) of burn >30%.
  • Burn depth full thickness or deeper on initial assessment.
  • Prior excision at another healthcare centre.
  • Patients with pre-existing malnutrition
  • Electrical, chemical or other unusual burn etiologies

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGStandard dressing

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

DRUGPluroGel

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.)


Locations(1)

University of Manitoba

Winnipeg, Manitoba, Canada

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04893863


Related Trials