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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at each dressing change

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

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

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Secondary outcome measures

Patient and caregiver satisfaction and perception of pain

Proportion requiring surgery

Relative surface area skin grafted

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 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Medline IndustriesIndustry Sponsor

45 Previous Clinical Trials

23,016 Total Patients Enrolled

4 Trials studying Burns

32 Patients Enrolled for Burns

University of ManitobaLead Sponsor

595 Previous Clinical Trials

199,501 Total Patients Enrolled

5 Trials studying Burns

62 Patients Enrolled for Burns

Media Library

PluroGel (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05000983 — Phase 1 & 2

Burns Research Study Groups: Test dressing, Standard dressing

Burns Clinical Trial 2023: PluroGel Highlights & Side Effects. Trial Name: NCT05000983 — Phase 1 & 2

PluroGel (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05000983 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are people still being accepted into the clinical trial?

"That is accurate. The listing on clinicaltrials.gov does show that the trial is ongoing and recruiting participants. The study was first posted on October 20th, 2021 with the most recent update being November 1st, 2022. They are looking for a total of 25 individuals from 1 site."

Answered by AI

Could you tell me how many subjects this trial is looking to include?

"That is correct. The clinicaltrials.gov website says that this study, which was originally posted on October 20th 2021, still needs patients. They are looking for 25 people total from 1 location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2021. "A Between Patient Study of Plurogel® Compared to Standard Topical Dressing in Burn Injuries". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05000983.