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NCT Number: NCT01731444

Phenylephrine Tumescence for Hemostasis in Surgery for Burn Injury

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.

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Key information

Conditions

Blood Loss, Surgical Burns Hemorrhage Intraoperative Complications Pathologic Processes Pathological Conditions, Signs and Symptoms Wounds and Injuries

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Manitoba

Winnipeg, Manitoba, R3A 1R9, Canada

Location status: Recruiting

Location contact

Justin P Gawaziuk, MSc

CONTACT

[email protected]

2047873669

Sarvesh Logsetty, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Head and neck, hand, foot, or genital burns
  • On anticoagulants (except NSAIDs)
  • On monoamine oxidase inhibitor or tricyclic antidepressant
  • Coronary or peripheral vascular disease
  • History of arrhythmias
  • On a Beta-blocker
  • History of vascular abnormality
  • Hypertension

Treatment and study plan

Phenylephrine

Drug

Primary outcomes

  1. Mean arterial blood pressure (MAP)

    Time frame: during first 30 minutes

    Mean arterial blood pressure

Secondary outcomes

  1. Blood Pressure

    Time frame: q15 min

    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

  2. Heart Rate

    Time frame: q15 min

    Recorded:

    • just prior to induction of anesthesia
    • maximum heart rate during time of procedure
    • minimum heart rate during time of procedure

Study contacts

Contact information is provided by the study sponsor or research team.

Justin Gawaziuk, MSc

CONTACT

[email protected]

2047873669

Sponsors and collaborators

Lead sponsor

University of Manitoba

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2028
Study completion
2028
First posted
Nov 21, 2012
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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