Blood Flow Change After Free Flap Surgery in Diabetic Patients

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03027219
• Other study ID #: S2016-2043-0003
• Status: Completed
• Start date: January 31, 2017
• Est. completion date: November 29, 2018

Study information

• Verified date: November 2018
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: November 29, 2018
• Est. primary completion date: November 2, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes

Intervention

Drug:
• Alprostadil
Vasodilator for anastomosis-site of free flap

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Flow change	Peak velocity of anastomosis-site of free flap	before alprostadil administration, 30 mins after alprostadil administration