Arteriovenous Loop Graft for Free Functional Gracilis Transfer in Brachial Plexus Surgery

Brachial Plexus Injury Clinical Trial

Official title:

Pilot Study of Arteriovenous Loop Graft for Free Functional Gracilis Transfer in Brachial Plexus Injured Patients With Insufficient Flow of Donor Artery

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06437990
• Other study ID #: 652/2556(EC4)
• Status: Enrolling by invitation
• Phase: N/A
• Start date: November 19, 2015
• Est. completion date: July 31, 2024

Study information

• Verified date: May 2024
• Source: Siriraj Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Free functional muscle transfer (FFMT) using the gracilis muscle as a donor muscle has become a standard treatment for reconstructing late-onset brachial plexus injuries. Successful implementation of this procedure relies on the availability of functional donor vessels in the injured limb to supply the muscle flap. However, some brachial plexus injuries are accompanied by subclavian or axillary artery injuries, which compromise the viability of the muscle flap due to insufficient vascular supply. To address this, arteriovenous (AV) loop grafts have been employed to extend donor vessels to the flap and have been utilized in various body regions, including the upper extremity. Despite their widespread use, AV loop grafts have not been previously utilized in FFMT for late-onset brachial plexus injuries with concurrent subclavian or axillary artery injuries. This study aimed to assess the feasibility of this surgical approach and report the long-term outcomes of the procedure.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 10
• Est. completion date: July 31, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Age equal or more than 20 years old

• Patients with brachial plexus injury with depletion of blood flow to the injured limb which confirmed by abnormal computed tomography arteriogram

Exclusion Criteria:

• Patients who had sufficient thoraco-acromial or thoraco-dorsal artery blood flow for standard free functional muscle transfer operation without the need of an AV loop graft

Related Conditions & MeSH terms

• Brachial Plexus Injury

Intervention

Procedure:
• Arteriovenous loop graft
Using saphenous vein graft to create an arteriovenous loop from the common carotid artery to the external jugular vein, providing vascular supply for a free functional gracilis muscle flap in patients with late-onset brachial plexus injury with concomitant subclavian or axillary artery injury.

Locations

Country	Name	City	State
Thailand	Faculty of Medicine Siriraj Hospital, Mahidol University	Bangkoknoi	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Siriraj Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Viability of the flap	Survival of the flap after the surgery	1 month
Secondary	Motor power	Medical Research Council (MRC) grading for motor power assessment	12 months, 18 months
Secondary	Complications	Bleeding, infection, blood transfusion, stroke, embolism, thrombosis	1 month
Secondary	Operative time	Total operative time including flap revision surgery or other related complications	1 month