Phenylephrine Tumescence for Hemostasis in Surgery for Burn Injury

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2014 by University of Manitoba
Sponsor:
Information provided by (Responsible Party):
University of Manitoba
ClinicalTrials.gov Identifier:
NCT01731444
First received: November 15, 2012
Last updated: April 16, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Blood Loss, Surgical
Drug: Phenylephrine
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phenylephrine Tumescence for Hemostasis in Surgery for Burn Injury - A Randomized Control Trial

Resource links provided by NLM:


Further study details as provided by University of Manitoba:

Primary Outcome Measures:
  • Mean arterial blood pressure (MAP) [ Time Frame: during first 30 minutes ] [ Designated as safety issue: Yes ]
    Mean arterial blood pressure


Secondary Outcome Measures:
  • Blood Pressure [ Time Frame: q15 min ] [ Designated as safety issue: Yes ]

    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

  • Heart Rate [ Time Frame: q15 min ] [ Designated as safety issue: Yes ]

    Recorded:

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


Estimated Enrollment: 24
Study Start Date: September 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Phenylephrine
20 ug/cc
Drug: Phenylephrine
Active Comparator: Epinephrine
1:1000000
Drug: Phenylephrine

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Burn injury requiring debridement and grafting between 5-30% total body surface area
  • Areas are not tourniquet able (i.e. trunk, proximal limbs)

Exclusion Criteria:

  • Head and neck, hand, foot, or genital burns
  • On anticoagulants (except Plavix or NSAIDS)
  • Coronary or peripheral vascular disease
  • History of arrhythmias
  • On a Beta-blocker
  • History of vascular abnormality
  • Hypertension
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01731444

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

Sponsors and Collaborators
University of Manitoba
  More Information

No publications provided

Responsible Party: University of Manitoba
ClinicalTrials.gov Identifier: NCT01731444     History of Changes
Other Study ID Numbers: PhenylephrineRCT
Study First Received: November 15, 2012
Last Updated: April 16, 2014
Health Authority: Canada: Health Canada

Keywords provided by University of Manitoba:
blood loss
burn
hemostasis

Additional relevant MeSH terms:
Burns
Hemorrhage
Blood Loss, Surgical
Wounds and Injuries
Pathologic Processes
Intraoperative Complications
Hemostatics
Phenylephrine
Oxymetazoline
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Cardiotonic Agents
Cardiovascular Agents
Mydriatics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sympathomimetics
Vasoconstrictor Agents
Nasal Decongestants
Respiratory System Agents
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents

ClinicalTrials.gov processed this record on August 19, 2014