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

November 15, 2012
April 16, 2014
September 2013
November 2014   (final data collection date for primary outcome measure)
Mean arterial blood pressure (MAP) [ Time Frame: during first 30 minutes ] [ Designated as safety issue: Yes ]
Mean arterial blood pressure
Same as current
Complete list of historical versions of study NCT01731444 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Blood Loss, Surgical
Drug: Phenylephrine
  • Experimental: Phenylephrine
    20 ug/cc
    Intervention: Drug: Phenylephrine
  • Active Comparator: Epinephrine
    1:1000000
    Intervention: Drug: Phenylephrine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
24
December 2015
November 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact: Justin Gawaziuk, MSc 2047873669 jgawaziuk@hsc.mb.ca
Not Provided
 
NCT01731444
PhenylephrineRCT
Yes
University of Manitoba
University of Manitoba
Not Provided
Not Provided
University of Manitoba
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP