Phenylephrine Tumescence for Hemostasis in Surgery for Burn Injury

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

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.

Study Overview

• Status: Recruiting
• Conditions: Blood Loss, Surgical
• Intervention / Treatment: Drug: Phenylephrine

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Justin Gawaziuk, MSc; Phone Number: 2047873669; Email: jgawaziuk@hsc.mb.ca

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3A 1R9
      • Recruiting
      • University of Manitoba
      • Contact: Justin P Gawaziuk, MSc; Phone Number: 2047873669; Email: jgawaziuk@hsc.mb.ca
      • Principal Investigator: Sarvesh Logsetty, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria

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

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Phenylephrine; 20 ug/cc	Drug: Phenylephrine
Active Comparator: Epinephrine; 1:1000000	Drug: Phenylephrine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean arterial blood pressure (MAP)	Mean arterial blood pressure	during first 30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	q15 min
Heart Rate	Recorded: just prior to induction of anesthesia; maximum heart rate during time of procedure; minimum heart rate during time of procedure	q15 min

Collaborators and Investigators

• Sponsor: University of Manitoba

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2014
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: November 15, 2012
• First Submitted That Met QC Criteria: November 20, 2012
• First Posted (Estimated): November 21, 2012

Study Record Updates

• Last Update Posted (Actual): December 1, 2023
• Last Update Submitted That Met QC Criteria: November 30, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: blood loss; hemostasis; burn
• Additional Relevant MeSH Terms: Pathologic Processes; Intraoperative Complications; Hemorrhage; Blood Loss, Surgical; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Protective Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Cardiotonic Agents; Respiratory System Agents; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Nasal Decongestants; Adrenergic alpha-1 Receptor Agonists; Phenylephrine; Oxymetazoline
• Other Study ID Numbers: PhenylephrineRCT