Phenylephrine Tumescence for Hemostasis in Surgery for Burn Injury

• Sponsor: University of Manitoba (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT01731444
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 96
• Patients Per Site Per Month: 0.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Blood Loss, Surgical	Drug: Phenylephrine	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phenylephrine Tumescence for Hemostasis in Surgery for Burn Injury - A Randomized Control Trial
• Actual Study Start Date: Dec 1, 2014
• Anticipated Primary Completion Date: Jun 1, 2022
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Phenylephrine 20 ug/cc	Drug: Phenylephrine
Active Comparator: Epinephrine 1:1000000	Drug: Phenylephrine

Outcome Measures

Primary Outcome Measures

1. Mean arterial blood pressure (MAP) [during first 30 minutes]

   Mean arterial blood pressure

Secondary Outcome Measures

1. 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

2. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria

1. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Manitoba	Winnipeg	Manitoba	Canada	R3A 1R9

Sponsors and Collaborators

• University of Manitoba

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Manitoba
• ClinicalTrials.gov Identifier: NCT01731444
• Other Study ID Numbers: PhenylephrineRCT
• First Posted: Nov 21, 2012
• Last Update Posted: May 17, 2022
• Last Verified: May 1, 2022

• Keywords provided by University of Manitoba: blood loss; burn; hemostasis
• Additional relevant MeSH terms: Hemorrhage; Blood Loss, Surgical; Phenylephrine; Oxymetazoline

Study Results

No Results Posted as of May 17, 2022