Phenylephrine Tumescence for Hemostasis in Surgery for Burn Injury

NCT01731444 | Recruiting Phase 1 DMC

• 1 other identifier: PhenylephrineRCT
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Blood Loss, Surgical

Keywords

blood loss; burn; hemostasis

Outcome Measures

Primary Outcomes (1)

• Mean arterial blood pressure (MAP)

  Mean arterial blood pressure

  during first 30 minutes

Secondary Outcomes (2)

• Blood Pressure

  q15 min

• Heart Rate

  q15 min

Study Arms (2)

Phenylephrine

EXPERIMENTAL

20 ug/cc

Drug: Phenylephrine

Epinephrine

ACTIVE COMPARATOR

1:1000000

Drug: Phenylephrine

Interventions

Phenylephrine DRUG

Epinephrine; Phenylephrine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• a) Burn injury requiring debridement and grafting between 5-30% TBSA

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

University of Manitoba

Winnipeg, Manitoba, R3A 1R9, Canada

RECRUITING

MeSH Terms

Conditions

Blood Loss, Surgical; Hemorrhage; Burns

Interventions

Phenylephrine

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraoperative Complications; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines

Central Study Contacts

Justin Gawaziuk, MSc

CONTACT

2047873669; jgawaziuk@hsc.mb.ca

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2012
• First Posted: November 21, 2012
• Study Start: December 1, 2014
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 5, 2024

Record last verified: 2024-12

Locations

CA (1)