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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 bilateral limb partial thickness burn injuries of similar depth requiring admission

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 14 days

Awards & highlights

Study Summary

This trial found that the use of an enzymatic debridement agent derived from pineapple was not effective and may have caused harm.

Who is the study for?

This trial is for individuals with partial thickness burns on both limbs that need hospital admission. It's not for those with more than 30% of their body burned, full-thickness burns at first check, previous burn treatment elsewhere, malnutrition before the injury, or burns from electricity or chemicals.Check my eligibility

What is being tested?

The study compares PluroGel®, a potential new treatment for burn injuries, to standard antibiotic dressings. The goal is to see if PluroGel® can reduce pain and improve healing without needing as much surgical removal of damaged tissue.See study design

What are the potential side effects?

While specific side effects are not listed here, typical reactions might include discomfort at the application site, possible allergic reactions to ingredients in PluroGel®, or infection due to changes in wound care routine.

Eligibility Criteria

Inclusion Criteria

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

Select...

I have burns on both limbs that need hospital care.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 14 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~14 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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

Proportion healed

Secondary outcome measures

Proportion requiring surgery

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?

University of ManitobaLead Sponsor

595 Previous Clinical Trials

199,461 Total Patients Enrolled

5 Trials studying Burns

67 Patients Enrolled for Burns

Media Library

Standard dressing (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04893863 — Phase 1 & 2

Burns Research Study Groups: Test dressing, Standard dressing

Burns Clinical Trial 2023: Standard dressing Highlights & Side Effects. Trial Name: NCT04893863 — Phase 1 & 2

Standard dressing (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04893863 — Phase 1 & 2

Frequently Asked Questions

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

How many people have been recruited to participate in this research project?

"That is correct. The listing on clinicaltrials.gov shows that this study, which was first put up on October 1st 2021, is still seeking patients. They are looking for 20 individuals total at a single location."

Answered by AI

Are people still being signed up for this experiment?

"The answer is affirmative, as the website clinicaltrials.gov has the latest information on this study which is recruiting patients. 20 individuals are needed for this research project taking place at 1 location, with the trial dates having begun on October first 2021 and updated most recently on May sixteenth 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Dr. Sarvesh Logsetty 2021. "A Study of Plurogel® Compared to Standard Topical Dressing in Burn Injuries". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04893863.