Intraoperative ICG for Systemic Sclerosis

• Status: Withdrawn
• Trial end date: 2018-01-23
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is to evaluate the relative intraoperative improvement in perfusion between arterial reconstruction and sympathectomies with quantitative ICG. A minimum of 40 patients, 20 Sympathectomy Prior to Bypass (group 1) and 20 Bypass Prior to Sympathectomy (group 2), will be recruited for this study. This study will enroll participants in a one to one randomized study design. There is the potential risk of loss of confidentiality. The study involves the intraoperative assessment of perfusion by quantitative ICG. ICG is FDA approved for this usage and will be used according to its labeling. Assessment involves intraoperative quantitative ICG data, questionnaires, and patient and physician assessments. There are no additional physical risks associated with participating in this study over and above that of the planned arterial reconstruction (bypass) and sympathectomies.The information collected will be kept confidential and will comply with the HIPAA.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Duke University

Criteria

Inclusion Criteria:

• o Patient has signed an IRB approved, study specific Informed Patient Consent Form.

• Patient is a male or non-pregnant female age 18 - 85 years at time of study enrollment.

• Patient has a diagnosis of a systemic sclerosis with vascular obstruction of the hand resulting in digital ischemia, ulceration, and/or gangrene and have failed nonoperative treatments.

• Patient is willing and able to comply with postoperative scheduled clinical evaluations.

Exclusion Criteria:

• • Patient is undergoing revision surgery.

• Patient has a diagnosis of avascular necrosis or inflammatory arthritis.

• If, during surgery, the arterial reconstruction could not be performed because the vessel was damaged to the point where there was no appropriate site for a bypass anastomosis.

• Patient is a prisoner

• Pregnant women confirmed by testing prior to surgery, and nursing mothers

• Patient has an allergy to iodine confirmed during initial history and on day of surgery