Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
NCT05000983

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

Led by University of Manitoba · Updated on 2026-05-14

25

Participants Needed

1

Research Sites

427 weeks

Total Duration

On this page

Sponsors

U

University of Manitoba

Lead Sponsor

M

Medline Industries

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Persons with partial thickness face burns or unilateral limb burn injuries requiring admission.
Not Eligible

You will not qualify if you...

  • Total burn surface area (TBSA) >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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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2
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Trial Site Locations

Total: 1 location

1

University of Manitoba

Winnipeg, Manitoba, Canada, R3A 1R9

Actively Recruiting

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Research Team

J

Justin Gawaziuk, MSc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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A Between Patient Study of Plurogel® Compared to Standard Topical Dressing in Burn Injuries | DecenTrialz