Blood Flow Change After Free Flap Surgery in Diabetic Patients

November 29, 2018 updated by: Young-Kug Kim, Asan Medical Center

Prospective Observational Study of the Changes of Blood Flow of Arterial Anastomosis-site of Free Flap in Diabetic Patients Who Undergoing Free Flap Transfer

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

44

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 79 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Diabetic patients who are undergoing free flap surgery

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Flow change
Time Frame: before alprostadil administration, 30 mins after alprostadil administration
Peak velocity of anastomosis-site of free flap
before alprostadil administration, 30 mins after alprostadil administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asan Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 31, 2017

Primary Completion (ACTUAL)

November 2, 2018

Study Completion (ACTUAL)

November 29, 2018

Study Registration Dates

First Submitted

January 18, 2017

First Submitted That Met QC Criteria

January 19, 2017

First Posted (ESTIMATE)

January 23, 2017

Study Record Updates

Last Update Posted (ACTUAL)

November 30, 2018

Last Update Submitted That Met QC Criteria

November 29, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S2016-2043-0003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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