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Phenylephrine Tumescence for Hemostasis in Surgery for Burn Injury

StatusRecruiting
PhasePhase 1
Started
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Record History

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  1. Primary completion date: Jun 1, 2026 to Jun 1, 2028
    • Study completion date: Dec 2027 to Dec 31, 2028
    v16
  2. Primary completion date: Jun 1, 2025 to Jun 1, 2026
    • Study completion date: Dec 2026 to Dec 2027
    v15
  3. Primary completion date: Jun 2025 to Jun 1, 2025
    • Start date: Dec 2014 to Dec 1, 2014
    v14
  4. Primary completion date: Jun 2022 to Jun 2025
    • Study completion date: Dec 2022 to Dec 2026
    v13
  5. Re-verified, no change to tracked fieldsv12
Show 10 earlier versionsHide 10 earlier versions
  1. Primary completion date: Jun 2021 to Jun 2022
    • Study completion date: Dec 2021 to Dec 2022
    v11
  2. Primary completion date: May 2020 to Jun 2021
    • Study completion date: Jun 2020 to Dec 2021
    v10
  3. Primary completion date: May 2018 to May 2020
    • Study completion date: Jun 2018 to Jun 2020
    v9
  4. Primary completion date: May 2016 to May 2018
    • Study completion date: Jun 2016 to Jun 2018
    v8
  5. Re-verified, no change to tracked fieldsv7
  6. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Primary completion date: Nov 2015 to May 2016
    • Study completion date: Dec 2016 to Jun 2016
    v6
  7. Primary completion date: Nov 2014 to Nov 2015
    • Start date: Sep 2013 to Dec 2014
    • Study completion date: Dec 2015 to Dec 2016
    • Eligibility criteria shortened, about 6 words
    v5
  8. Re-verified, no change to tracked fieldsv4
  9. Primary completion date: Nov 2013 to Nov 2014
    • Start date: Nov 2012 to Sep 2013
    • Study completion date: Dec 2014 to Dec 2015
    v3
  10. Re-verified, no change to tracked fieldsv2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The standard of care for treatment of burn injury is to inject a solution of epinephrine under the skin of the injured site in order to reduce blood loss during skin grafting. This solution of epinephrine has been shown to have effects on the body outside the donor site. Some people have increases in heart rate and blood pressure. We will study the effect of a phenylephrine solution in place of an epinephrine solution to control blood loss. We think that phenylephrine will help decrease blood loss and not change blood pressure or heart rate. The injured area will be injected under the skin and a skin graft will be taken in the same way as we usually do. The only change will be the use of phenylephrine in the solution instead of epinephrine. Our goal is to find whether or not phenylephrine or epinephrine solution results in a reduction of blood loss without affecting the rest of the body.
Trial Details
NCT Number NCT01731444
Lead Sponsor University of Manitoba
Conditions
(from sponsor)		 Blood Loss, Surgical
Related terms Blood Loss, Surgical, Burns, Hemorrhage
Enrollment 24 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov