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Summary

for people ages 18 years and up (full criteria)
healthy people welcome
at San Francisco, California
study started
estimated completion:

Description

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.

Details

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 140 patients (70 per cohort).

The primary outcome is return to functional independence at discharge. Secondary outcomes include wound dehiscence, infection, reoperation, interventional radiology intervention, seroma, and sequela associated with prolonged bedrest including respiratory infections, duration of hospitalization, need for SNF upon discharge, and physiologic deconditioning. 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.

Keywords

Functional Status After Sartorius Flap of the Groin Wound Complication

Eligibility

You can join if…

Open to people ages 18 years and up

  • All patients undergoing muscle flaps following infrainguinal, open vascular surgery.Patients must be ambulatory at baseline. Patients must be able to provide informed consent.

You CAN'T join if...

  • Patients who are unable to provide informed consent. Patients are non-ambulatory at baseline. Patients' clinical status is not amenable towards early ambulation.Enrollment is at the discretion of the vascular and plastic surgeons.
  • Bilateral sartorius flaps

Location

  • University of California, San Francisco accepting new patients
    San Francisco, California, 94143, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT03477682
Lead Scientist
Scott Hansen
Study Type
Interventional
Last Updated
March 19, 2018
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