Phenylephrine Tumescence for Hemostasis in Surgery for Burn Injury

Blood Loss, Surgical Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01731444
• Other study ID #: PhenylephrineRCT
• Status: Recruiting
• Phase: Phase 1
• Start date: December 1, 2014
• Est. completion date: December 2026

Study information

• Verified date: November 2023
• Source: University of Manitoba
• Contact: Justin Gawaziuk, MSc
• Phone: 2047873669
• Email: jgawaziuk[@]hsc.mb.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: December 2026
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Blood Loss, Surgical
• Hemorrhage

Intervention

Drug:
• Phenylephrine

Locations

Country	Name	City	State
Canada	University of Manitoba	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
University of Manitoba

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean arterial blood pressure (MAP)	Mean arterial blood pressure	during first 30 minutes
Secondary	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
Secondary	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