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Phenylephrine Tumescence for Hemostasis in Surgery for Burn Injury

NCT ID: NCT01731444

Last Updated: 2024-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-01

Study Completion Date

2027-12-31

Brief Summary

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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

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Conditions

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Blood Loss, Surgical

Keywords

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blood loss burn hemostasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Phenylephrine

20 ug/cc

Group Type EXPERIMENTAL

Phenylephrine

Intervention Type DRUG

Epinephrine

1:1000000

Group Type ACTIVE_COMPARATOR

Phenylephrine

Intervention Type DRUG

Interventions

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Phenylephrine

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Manitoba

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Manitoba

Winnipeg, Manitoba, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Justin Gawaziuk, MSc

Role: CONTACT

Phone: 2047873669

Email: [email protected]

Facility Contacts

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Justin P Gawaziuk, MSc

Role: primary

Other Identifiers

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PhenylephrineRCT

Identifier Type: -

Identifier Source: org_study_id