Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
ID05000983

A Between Patient, Pilot Randomized Controlled 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

56 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 cause long-lasting physical and mental effects due to scarring and painful dressings. The usual treatment involves antibiotic topical dressings while waiting to determine the depth of the burn, followed by surgery for deeper burns. Assessing burn depth is difficult, and surgical removal of damaged tissue may remove some healthy tissue. New methods like hydro-dissection devices and enzymatic treatments like Bromolein have been explored but lack clear proof of benefit and may sometimes cause harm. This research compares PluroGel®, a special gel that helps soften and remove dead tissue while keeping the wound moist, to the standard antibiotic ointment and gauze dressings. PluroGel® is applied in a 0.5 cm layer with moist gauze twice daily, alongside the standard dressing applied three times a week. The study will assess if PluroGel® improves wound healing and reduces the need for surgery. Participants will receive either the standard dressing or PluroGel® treatment and will be followed for up to 14 days. Researchers will monitor wound healing, pain levels, satisfaction of patients and caregivers, and whether surgery is needed. The study uses a randomized, double-blind design and aims to provide evidence on the effectiveness of PluroGel® in burn care.

CONDITIONS

Brief 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
  • Age 18 years or older
Not Eligible

You will not qualify if you...

  • Total burn surface area (TBSA) greater than 30%
  • Full thickness or deeper burn on initial assessment
  • Prior excision surgery at another healthcare center
  • Pre-existing malnutrition
  • Electrical, chemical, or unusual burn types

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - 1 to 14 days

Participants receive either PluroGel® with moist gauze and standard dressing or standard topical antibiotic dressing applied regularly to their burn injuries.

Dressing changes every Monday, Wednesday, and Friday, with moist gauze kept moist twice daily for those in the PluroGel® group

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

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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