Actively Recruiting

Phase 1
Age: 18Years - 75Years
All Genders
ID01731444

Phenylephrine Tumescence for Hemostasis in Surgery for Burn Injury - A Randomized Control Trial

Led by University of Manitoba · Updated on 2026-05-14

24

Participants Needed

1

Research Sites

30 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the use of phenylephrine compared to epinephrine to control blood loss during skin graft surgery for burn injuries covering 5-30% of total body surface area. This Phase 1 randomized trial aims to find out if phenylephrine can reduce blood loss without affecting heart rate or blood pressure, as epinephrine sometimes causes increases in these vital signs. Participants will receive injections under the skin of the burn injury site with either a phenylephrine solution or the standard epinephrine solution before skin grafting. The procedure and grafting technique remain the same; only the solution used for tumescence differs. The study compares these two drugs to assess their effects during surgery. During the first 30 minutes after injection, researchers will monitor mean arterial blood pressure closely, along with blood pressure and heart rate every 15 minutes. The study involves careful observation of these vital signs to evaluate the safety and effectiveness of phenylephrine in controlling blood loss. The total participation duration and further follow-up details are not specified.

CONDITIONS

Brief Title

Phenylephrine Tumescence for Hemostasis in Surgery for Burn Injury

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Burn injury requiring debridement and grafting between 5-30% total body surface area
  • Age between 18 and 75 years
Not Eligible

You will not qualify if you...

  • Burns on head, neck, hand, foot, or genital areas
  • Use of anticoagulants (except NSAIDs)
  • Use of monoamine oxidase inhibitors or tricyclic antidepressants
  • History of coronary or peripheral vascular disease
  • History of arrhythmias
  • Use of Beta-blockers
  • History of vascular abnormalities
  • Hypertension

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - During surgery and immediate post-operative period

Participants receive phenylephrine or epinephrine during surgery for burn injury to control bleeding.

1 surgical visit with monitoring every 15 minutes for 30 minutes

Trial Site Locations

Total: 1 location

1

University of Manitoba

Winnipeg, Manitoba, Canada, R3A 1R9

Actively Recruiting

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Research Team

J

Justin Gawaziuk, MSc

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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