ClinicalTrials.gg
RecruitingNCT01731444Updated May 14, 2026

Phenylephrine Tumescence for Hemostasis in Surgery for Burn Injury

A Phase 1 interventional study of Phenylephrine in Blood Loss, Surgical, sponsored by University of Manitoba. Recruiting at 1 site in Canada. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-05-14.

Sponsored by University of Manitoba · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Dec 2014; still recruiting 11 years 11 months later.

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Phase
Phase 1
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 21 studies in Blood Loss, Surgical with a site in Canada — 5 open to participants now, 6 under way, 2 of them phase 3. Blood Loss, Surgical · Canada.

Planned enrollment
17th of 17
24 · median 125
Started
2014
the only one that year
Phase 1
Only one
of the 21
Registered
9th of 21
by date

Among the 21 studies in Blood Loss, Surgical with a site in Canada, this one is the 17th largest by planned enrollment of the 17 interventional ones that give a count, is the only one that started in 2014, is the only one in phase 1, and was the 9th registered.

Blood Loss, Surgical

213 studies on the registry are indexed under Blood Loss, Surgical; 40 are open to participants now.

Browse Blood Loss, Surgical studies →

Open to participants now

5 of the 21 studies in Blood Loss, Surgical with a site in Canada are open now. Recruiting first, the newest first:

All 5 open studies →

A study can be open while its sites in Canada have not opened yet or have stopped. Only those recruiting at a site in Canada →

Who these studies take

Of the 27 Blood Loss, Surgical studies recruiting now, 10 (37%) set no upper age limit and 14 (52%) stop at 75 or younger; 6 take children under 18; 4 take healthy volunteers.

This study: 18 Years to 75 Years · all sexes · no healthy volunteers.

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02

Study summary

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.

03

Conditions studied

  • Blood Loss, Surgical

Keywords

  • blood loss
  • burn
  • hemostasis
04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

a) Burn injury requiring debridement and grafting between 5-30% TBSA

Exclusion criteria

Exclusion Criteria

  1. Head and neck, hand, foot, or genital burns
  2. On anticoagulants (except NSAIDs)
  3. On monoamine oxidase inhibitor or tricyclic antidepressant
  4. Coronary or peripheral vascular disease
  5. History of arrhythmias
  6. On a Beta-blocker
  7. History of vascular abnormality
  8. Hypertension
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
24 participants (estimated)

Study arms

  • Experimental
    Phenylephrine

    20 ug/cc

    Drug: Phenylephrine

  • Active comparator
    Epinephrine

    1:1000000

    Drug: Phenylephrine

Interventions

06

What researchers measure

Primary outcomes

  1. Mean arterial blood pressure (MAP)

    Mean arterial blood pressure

    Time frame: during first 30 minutes

Secondary outcomes

  1. Blood Pressure

    Cut off for safety: Diastolic \>140 or Systolic \>180; Recorded: * just prior to induction of anesthesia * maximum heart rate during time of procedure * minimum heart rate during time of procedure

    Time frame: q15 min

  2. Heart Rate

    Recorded: * just prior to induction of anesthesia * maximum heart rate during time of procedure * minimum heart rate during time of procedure

    Time frame: q15 min

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Dec 2014 (actual). Primary completion is estimated for Jun 2028, 162 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 15, 2012
First posted
Nov 21, 2012
StartActual
Dec 1, 2014
Primary completionEst.
Jun 1, 2028
CompletionEst.
Dec 31, 2028
Last update
May 14, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01731444
Responsible party
Sponsor
First posted
Nov 21, 2012
Start date
Dec 1, 2014
Primary completion
Jun 1, 2028 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
May 14, 2026

Study contacts

Justin Gawaziuk, MSc
Contact
jgawaziuk@hsc.mb.ca
2047873669

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Phenylephrine

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