NCT01731444 Phenylephrine Tumescence for Hemostasis in Surgery for Burn Injury
| NCT ID | NCT01731444 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | University of Manitoba |
| Condition | Blood Loss, Surgical |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2014-12-01 |
| Primary Completion | 2028-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 24 participants in total. It began in 2014-12-01 with a primary completion date of 2028-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT01731444 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Blood Loss, Surgical. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT01731444 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT01731444 currently recruiting?
Yes, NCT01731444 is actively recruiting participants. Contact the research team at jgawaziuk@hsc.mb.ca for enrollment information.
Where is the NCT01731444 trial being conducted?
This trial is being conducted at Winnipeg, Canada.
Who is sponsoring the NCT01731444 clinical trial?
NCT01731444 is sponsored by University of Manitoba. The trial plans to enroll 24 participants.