Phenylephrine Tumescence for Hemostasis in Surgery for Burn Injury

Phase 1

Recruiting

• Conditions: Blood Loss, Surgical
• Interventions: Drug: Phenylephrine

• Registration Number: NCT01731444
• Lead Sponsor: University of Manitoba

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-11-15
• Study First Submitted QC: 2012-11-20
• Study First Posted: 2012-11-21
• Study Start: 2014-12-01
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-05
• Primary Completion: 2026-06-01
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Phenylephrine	Phenylephrine	20 ug/cc
Epinephrine	Phenylephrine	1:1000000

Primary Outcome Measures

Name	Time	Method
Mean arterial blood pressure (MAP)	during first 30 minutes	Mean arterial blood pressure

Secondary Outcome Measures

Name	Time	Method
Heart Rate	q15 min	Recorded: * just prior to induction of anesthesia; * maximum heart rate during time of procedure; * minimum heart rate during time of procedure
Blood Pressure	q15 min	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

Trial Locations

Locations (1)

University of Manitoba; 🇨🇦 Winnipeg, Manitoba, Canada