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
Verified date | May 2024 |
Source | Siriraj Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Thailand | Faculty of Medicine Siriraj Hospital, Mahidol University | Bangkoknoi | Bangkok |
Lead Sponsor | Collaborator |
---|---|
Siriraj Hospital |
Thailand,
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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