Comparing Plurogel® to standard dressings for burn injuries
A Within Patient, Pilot Randomized Controlled Study of Plurogel® Compared to Standard Topical Dressing in Burn Injuries
This study tests if Plurogel® can help heal partial thickness burn injuries better than regular dressings and reduce the need for surgery in people with burns on both arms or legs.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Manitoba Academic / other |
| Locations | 1 site (Winnipeg, Manitoba) |
| Trial ID | NCT04893863 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of Plurogel® compared to standard antibiotic topical dressings in treating partial thickness burn injuries. The study aims to determine if Plurogel® can reduce the need for surgical debridement and improve healing outcomes. Participants will be individuals with bilateral limb partial thickness burns, and the trial will assess the healing process and pain management associated with each dressing type. The study is conducted in phases 1 and 2 to ensure safety and efficacy.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals with bilateral limb partial thickness burn injuries requiring hospitalization.
Not a fit: Patients with total body surface area burns greater than 30% or full thickness burns will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved healing and reduced surgical interventions for patients with burn injuries.
How similar studies have performed: While there have been various approaches to burn treatment, this specific comparison of Plurogel® to standard dressings is novel and has not been extensively tested in randomized controlled trials.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Persons with bilateral limb partial thickness burn injuries of similar depth requiring admission Exclusion Criteria: * Total body surface area (TBSA) of burn \>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
Where this trial is running
Winnipeg, Manitoba
- University of Manitoba — Winnipeg, Manitoba, Canada (Recruiting)
Study contacts
- Study coordinator: Justin Gawaziuk
- Email: jgawaziuk@hsc.mb.ca
- Phone: 2047878682
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.