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

NCT ID: NCT06437990

Last Updated: 2025-07-30

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-19

Study Completion Date

2024-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Brachial Plexus Injury

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Late-onset brachial plexus injury patient with concomitant subclavian or axillary artery injury
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arteriovenous loop graft

A saphenous vein graft was used 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.

Group Type EXPERIMENTAL

Arteriovenous loop graft

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Other Intervention Names

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AV loop graft

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Siriraj Hospital

OTHER

Sponsor Role lead

Responsible Party

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Panai Laohaprasitiporn, MD

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Panai Laohaprasitiporn, MD

Role: PRINCIPAL_INVESTIGATOR

Siriraj Hospital

Locations

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Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkoknoi, Bangkok, Thailand

Site Status

Countries

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Thailand

References

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Limthongthang R, Wongtrakul S, Laohaprasitiporn P, Monteerarat Y, Vathana T. Free Functional Muscle Transfer in Brachial Plexus Injury Patients With Subclavian Artery Injury Using Arteriovenous Loop Grafts. Microsurgery. 2025 Jan;45(1):e70020. doi: 10.1002/micr.70020.

Reference Type DERIVED
PMID: 39775958 (View on PubMed)

Other Identifiers

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652/2556(EC4)

Identifier Type: -

Identifier Source: org_study_id

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