NCT05000983 A Between Patient Study of Plurogel® Compared to Standard Topical Dressing in Burn Injuries
| NCT ID | NCT05000983 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | University of Manitoba |
| Condition | Burns |
| Study Type | INTERVENTIONAL |
| Enrollment | 25 participants |
| Start Date | 2021-10-20 |
| Primary Completion | 2028-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 25 participants in total. It began in 2021-10-20 with a primary completion date of 2028-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Burn injuries can result in long term physical and mental sequelae, not only from the scarring but also the painful dressings. The standard of care today remains use of antibiotic topical dressings while awaiting demarcation of the burn depth, with surgical excision and grafting for deep partial thickness and full thickness areas. Demarcation can be appreciated on admission for full thickness burns but is often a prolonged process that can last weeks. The clinical evaluation of the depth of the burn is a complex decision that often is made more challenging by the presence of the proteinaceous pseudoeschar and the coagulated dermis itself. Surgical debridement is relatively 'coarse' and by its very nature requires removal of a thin layer of viable tissue to reach the level that is vascularized enough to support a skin graft. There has been growing interest in the use of adjuncts to reduce the amount tissue debrided and potentially reduce the need for surgery itself. Operatively, there have been some reports that use of hydro-dissection devices (Versajet™) may allow a more controlled debridement, resulting in less viable tissue being sacrificed. There is also a growing experience with enzymatic debridement, especially with Bromolein, derived from Pineapple (NexoBrid®). Neither of these have been shown to definitively improve care in randomized controlled trials, (RCTs) and there is suggestion that in some settings may actually cause harm.
Eligibility Criteria
Inclusion Criteria: * Persons with partial thickness face burns or unilateral limb burn injuries requiring admission. Exclusion Criteria: * Total burn surface area (TBSA) \>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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05000983 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Burns. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05000983 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05000983 currently recruiting?
Yes, NCT05000983 is actively recruiting participants. Contact the research team at jgawaziuk@hsc.mb.ca for enrollment information.
Where is the NCT05000983 trial being conducted?
This trial is being conducted at Winnipeg, Canada.
Who is sponsoring the NCT05000983 clinical trial?
NCT05000983 is sponsored by University of Manitoba. The trial plans to enroll 25 participants.