Long Term Patency Following Arterial Repair

Completed

Conditions studied: Upper Extremity Arterial Surgery

In brief

Injury to the blood vessels of the extremities, and more specifically the arteries, can result from fractures and severe crush injuries. It occurs in about 3% of the general population. People affected by blood vessel injuries can have important problems, including cold intolerance, general pain, and weakened function of the associated limb. Even after surgical intervention to repair the affected artery, people may still experience numbness, problems with movement, and an inadequate supply of oxygen to the limb. These symptoms are particularly relevant in the case of forearm arterial repairs because this repair directly affects one of our most vital structures: the hand. Despite available interventions and advances in microsurgical technique, arterial repairs can still result in significant sensory and functional impairment of the hand. Once an artery within the arm is injured, a surgeon's primary goal is to restore blood flow to the hand and prevent functional impairment. Even with a prompt effort to restore hand perfusion, long-term (greater than 6 months) sensory and motor function is hard to predict. Furthermore, sometimes the repaired artery becomes occluded over time. We believe that this occlusion has a direct impact on a patient's perceived pain and cold intolerance at the level of the hand. In this study, we are investigating the occurrence of blood vessel occlusion in the arm after at least 6 months of surgery and the impact of this event. To assess this we will use physical exams, non-invasive tests, duplex doppler ultrasound and questionnaires. Questionnaires, including the DASH (disabilities of the arm, shoulder,and hand), CISS (Cold Intolerance Symptom Severity Questionnaire), and Michigan hand score, will be used to assess pain, sensory, and motor impairments in both the affected and unaffected hand. Functional assessments will include 2-point discrimination, grip strength, pinch strength, capillary refill and range of motion.

Key facts

Study ID

NCT02228057

Run by

University of Pittsburgh

People needed

13

Starts

2014-08-01

Expected to finish

2015-02-01

Last updated by the study team

2015-02-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients meeting the following criteria will be eligible to participate in this study:
• Age 18 and over
• Able to provide informed consent
• Have previously underwent surgery for an arm arterial repair
• Be at least 6 months post-arterial repair
• Willing and able to comply with follow-up tests/procedures and questionnaires

You may not qualify if…

• Patients meeting the following criteria will be excluded from this study:
• Age less than 18 years
• Unable to provide informed consent
• Nerve repair in extremity of interest
• Any condition which compromises the contralateral hand to serve as a reliable internal control

Where it is running

• University of Pittsburgh Scaife Hall — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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