NCT03477682

Postoperative Management of Groin Flaps for Vascular Coverage

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Functional Status After Sartorius Flap of the Groin
• Wound Complication

Interventions

Type	Name	Description
OTHER	Early ambulation	Patients who are in the experimental arm will have a shorter duration of bedrest restriction following sartorius surgery (1 day) versus the standard group (5 days bedrest).

Timeline

• Start date: 2017-11-07
• Primary completion: 2020-03-25
• Completion: 2021-06-30
• First posted: 2018-03-26
• Last updated: 2021-09-22

Locations

1 site across 1 country: United States