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

StatusRecruiting
PhasePhase 1/2
Started
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Record History

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  1. Minor Re-verified, no change to tracked fieldsv10
  2. Notable Primary completion date: Dec 31, 2026 to Dec 31, 2028
    • Study completion date: Jun 1, 2027 to Jun 1, 2029
    v9
  3. Notable Primary completion date: Dec 31, 2024 to Dec 31, 2026
    • Study completion date: Jun 1, 2025 to Jun 1, 2027
    v8
  4. Minor Re-verified, no change to tracked fieldsv7
  5. Notable Primary completion date: Dec 31, 2022 to Dec 31, 2024
    • Study completion date: Jun 1, 2023 to Jun 1, 2025
    v6
Show 4 earlier versionsHide 4 earlier versions
  1. Notable Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v5
  2. Notable Start date: Jun 1, 2021 to Oct 1, 2021v4
  3. Minor Secondary endpoint revised
    • Study title shortened, about 5 words
    v3
  4. Minor Secondary endpoints: details revised at 1 of 1 entryv2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 NCT04893863
Lead Sponsor University of Manitoba
Conditions
(from sponsor)
Burns
Related terms Burns, Wounds and Injuries
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov