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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT06437990
Other study ID # 652/2556(EC4)
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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