Ignite Creation Date:
2024-05-06 @ 3:11 AM
Last Modification Date:
2024-10-26 @ 11:29 AM
Study NCT ID:
NCT02228057
Status:
COMPLETED
Last Update Posted:
2015-02-13
First Post:
2014-08-25
Brief Title:
Long Term Patency Following Arterial Repair
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Long Term Patency Following Arterial Repair
Status:
COMPLETED
Status Verified Date:
2015-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 surgeons 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 patients 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 shoulderand 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
Furthermore sometimes the repaired artery becomes occluded over time We believe that this occlusion has a direct impact on a patients 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 shoulderand 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
Detailed Description:
Vascular injuries of the extremities can result from fractures severe crush injuries lacerations and even iatrogenic causes such as surgical interventions Its prevalence is about 3 in the general population with increased incidence during times of war Patients affected by vascular injuries can have significant morbidities including cold intolerance pain sensory abnormalities and weakness of the affected limb Even after repair of the affected artery patients may still experience paresthesias motor function abnormalities and pain and cold intolerance These symptoms are particularly relevant in the case of arm arterial repairs because this repair directly affects the function of the hand Different techniques of arterial repair have evolved over time Venous grafts ie saphenous and dorsal hand veins can be employed to repair the damaged vessel Although most appropriate for treating long gaps vein grafts have several disadvantages There is often a diameter mismatch between the harvested vein and the damaged artery which can compromise the repair site Furthermore veins are more compliant and have higher volume storage capabilities than their arterial counterparts These inherent venous qualities can alter blood flow to the limb causing stasis turbulence and eventually stenosis of the graft Other methodologies have been developed in an effort to balance the negatives associated with venous grafting including synthetic graft use arterial ligation end-to-side anastomosis and end-to-end repair Despite available interventions and advances in microsurgical technique arterial repair in the arm can still result in significant functional impairment of the upper extremity The hand is highly perfused with a dual arterial system that arches across the dorsal and palmar surface of the hand Once an upper extremity artery is compromised a surgeons primary goal is to restore blood flow to the hand so as to prevent impairment Despite a surgeons best efforts long term greater than 6 months outcomes are hard to predict Furthermore the patency rates of the arterial repair have been consistently reported at approximately 50 We believe that the long term patency of the upper extremity artery has a direct effect on a patients perceived pain and cold intolerance sensibility and motor function of the hand Our hypothesis is that repaired arteries in the upper extremity will have an occlusion rate of 50 in the long term greater than 6 months post-surgery and that this occlusion is responsible for motor and sensory function abnormalities pain and cold-intolerance We will use high resolution duplex Doppler ultrasound to investigate occlusion rates of repaired arteries and compare those to the unaffected contralateral arteries internal control 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 cold intolerance 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None