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Phenylephrine Tumescence for Hemostasis in Surgery for Burn Injury

Primary Purpose

Blood Loss, Surgical

Status
Recruiting
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Phenylephrine
Sponsored by
University of Manitoba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Blood Loss, Surgical focused on measuring blood loss, burn, hemostasis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of ManitobaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Phenylephrine

Epinephrine

Arm Description

20 ug/cc

1:1000000

Outcomes

Primary Outcome Measures

Mean arterial blood pressure (MAP)
Mean arterial blood pressure

Secondary Outcome Measures

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
Heart Rate
Recorded: just prior to induction of anesthesia maximum heart rate during time of procedure minimum heart rate during time of procedure

Full Information

First Posted
November 15, 2012
Last Updated
November 1, 2022
Sponsor
University of Manitoba
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1. Study Identification

Unique Protocol Identification Number
NCT01731444
Brief Title
Phenylephrine Tumescence for Hemostasis in Surgery for Burn Injury
Official Title
Phenylephrine Tumescence for Hemostasis in Surgery for Burn Injury - A Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 2014 (Actual)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Manitoba

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Loss, Surgical
Keywords
blood loss, burn, hemostasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Phenylephrine
Arm Type
Experimental
Arm Description
20 ug/cc
Arm Title
Epinephrine
Arm Type
Active Comparator
Arm Description
1:1000000
Intervention Type
Drug
Intervention Name(s)
Phenylephrine
Primary Outcome Measure Information:
Title
Mean arterial blood pressure (MAP)
Description
Mean arterial blood pressure
Time Frame
during first 30 minutes
Secondary Outcome Measure Information:
Title
Blood Pressure
Description
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
Time Frame
q15 min
Title
Heart Rate
Description
Recorded: just prior to induction of anesthesia maximum heart rate during time of procedure minimum heart rate during time of procedure
Time Frame
q15 min

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Justin Gawaziuk, MSc
Phone
2047873669
Email
jgawaziuk@hsc.mb.ca
Facility Information:
Facility Name
University of Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A 1R9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Justin P Gawaziuk, MSc
Phone
2047873669
Email
jgawaziuk@hsc.mb.ca
First Name & Middle Initial & Last Name & Degree
Sarvesh Logsetty, MD

12. IPD Sharing Statement

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Phenylephrine Tumescence for Hemostasis in Surgery for Burn Injury

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