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

StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Primary completion date: Nov 30, 2026 to Nov 30, 2028
    • Study completion date: Dec 31, 2027 to Dec 31, 2029
    v8
  2. Notable Primary completion date: Nov 30, 2024 to Nov 30, 2026
    • Study completion date: Dec 31, 2025 to Dec 31, 2027
    v7
  3. Notable Primary completion date: May 31, 2024 to Nov 30, 2024v6
  4. Minor Study completion date: Dec 31, 2024 to Dec 31, 2025v5
  5. Notable Primary completion date: May 31, 2022 to May 31, 2024
    • Study completion date: Dec 31, 2022 to Dec 31, 2024
    v4
Show 2 earlier versionsHide 2 earlier versions
  1. Notable Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v3
  2. Notable Start date: Sep 1, 2021 to Oct 20, 2021v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05000983
Lead Sponsor University of Manitoba
Collaborators: Medline Industries
Conditions
(from sponsor)
Burns
Related terms Burns, Wounds and Injuries
Enrollment 25 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov