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PluroGel vs Standard Dressing for Burns

Phase 1 & 2

Recruiting

Research Sponsored by University of Manitoba

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Persons with partial thickness face burns or unilateral limb burn injuries requiring admission.

Be older than 18 years old

Must not have

Total burn surface area (TBSA) >30%

Prior excision at another healthcare centre

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at each dressing change

Awards & highlights

No Placebo-Only Group

Summary

This trial is evaluating a new device that uses electrical current to help assess the depth of the burn and potentially improve the surgical debridement process.

Who is the study for?

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.

What is being tested?

The study compares PluroGel®, a new type of burn dressing, to standard antibiotic dressings used in burn care. The goal is to see if PluroGel® can improve healing and reduce the need for surgical removal of damaged tissue.

What are the potential side effects?

While specific side effects are not detailed here, typical concerns with topical treatments may include skin irritation at the application site, allergic reactions, and potential infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have burns on my face or one limb that needed hospital care.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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Over 30% of my body has been burned.

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I had surgery at a different hospital.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1-14 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1-14 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-14 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Secondary study objectives

Patient and caregiver satisfaction and perception of pain

Proportion requiring surgery

Relative surface area skin grafted

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Test dressingExperimental Treatment1 Intervention

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.)

Group II: Standard dressingActive Control1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

PluroGel

2013

Completed Phase 2

~50

0 / 3Eligibility criteria met