Blood Flow Change After Free Flap Surgery in Diabetic Patients

• Sponsor: Asan Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT03027219
• Collaborator: (none)
• Enrollment: 44
• Location: 1
• Actual Duration (Months): 21.9
• Patients Per Site Per Month: 2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Diabetes	Drug: Alprostadil

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 Design

• Study Type: Observational
• Actual Enrollment: 44 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• 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
• Actual Study Start Date: Jan 31, 2017
• Actual Primary Completion Date: Nov 2, 2018
• Actual Study Completion Date: Nov 29, 2018

Outcome Measures

Primary Outcome Measures

1. Flow change [before alprostadil administration, 30 mins after alprostadil administration]

   Peak velocity of anastomosis-site of free flap

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 79 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Asan Medical Center	Seoul		Korea, Republic of	05505

Sponsors and Collaborators

• Asan Medical Center

Investigators

• Principal Investigator: Young-kug Kim, MD, PhD, Asan Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Young-Kug Kim, Professor, Asan Medical Center
• ClinicalTrials.gov Identifier: NCT03027219
• Other Study ID Numbers: S2016-2043-0003
• First Posted: Jan 23, 2017
• Last Update Posted: Nov 30, 2018
• Last Verified: Nov 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Alprostadil

Study Results

No Results Posted as of Nov 30, 2018