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Clinical Trial Summary

This is a randomized controlled trial designed to analyze the impact of bedrest duration on return to functional independence at discharge following sartorius flap for coverage of vascular reconstruction in the groin.


Clinical Trial Description

This is a pilot prospective study with the purpose of evaluating the impact of bedrest duration on outcomes of groin muscle flaps used for groin coverage in patients undergoing open, infrainguinal vascular surgery. The investigators plan to target all patients undergoing groin muscle flaps for vascular groin coverage at UCSF. All patients undergoing groin flaps will be block randomized into two cohorts: Cohort 1 - one day of bedrest (mobilize on post-op day 2) versus Cohort 2 - 5 days of bedrest (mobilize on post-op day 6). The investigators perform approximately 50 infrainguinal muscle flaps per year. They aim to enroll 30 patients (15 per cohort). Outcome measures include: surgical complication rates (including wound and lymphatic complications, readmissions, and reoperations), physical function, hospital length of stay, venous thromboembolism (VTE), and rates of discharge to a skilled nursing facility. The investigators will also examine the impact of bedrest on patient reported outcomes one month following surgery. Patient outcomes will be followed for 3 months post-operatively. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03477682
Study type Interventional
Source University of California, San Francisco
Contact
Status Completed
Phase N/A
Start date November 7, 2017
Completion date June 30, 2021

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