Blood Flow Change After Free Flap Surgery in Diabetic Patients

NCT ID: NCT03027219

Last Updated: 2018-11-30

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

44 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-31

Study Completion Date

2018-11-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

We aim to evaluate the flow change of arterial anastomosis site during free flap surgery in diabetic patients.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Objective: flow change of arterial anastomosis site during free flap surgery in diabetic patients.

Background: No research was published about flow change of arterial anastomosis site of the free flap during surgery.

Plan: Using Duplex sonography, various parameters related flap perfusion will be evaluated before and after the administration of alprostadil.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Alprostadil

Vasodilator for anastomosis-site of free flap

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Eglandin

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Plan to receive free flap transfer under general anesthesia
2. Age: \>=18 and \<80 years old
3. History of diabetes mellitus
4. Administration of alprostadil during surgery
5. Volunteer, who are provided written informed consent prior to study participation

Exclusion Criteria

1. Refuse the participation of study
2. \>= American society of anesthesiologist physical status IV
3. Use of any vasopressor or inotropic for hemodynamic instability before participation of study
4. Inappropriate subjects who are identified by researchers
Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Asan Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Young-Kug Kim

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Young-kug Kim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Asan Medical Center

Seoul, , South Korea

Site Status

Countries

Review the countries where the study has at least one active or historical site.

South Korea

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

S2016-2043-0003

Identifier Type: -

Identifier Source: org_study_id