Postoperative Management of Groin Flaps for Vascular Coverage



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:4/17/2018
Start Date:November 7, 2017
End Date:November 2020
Contact:Scott L Hansen, MD
Email:scott.hansen@ucsf.edu
Phone:4153534285

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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.

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.

Inclusion Criteria:

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

Exclusion Criteria:

- 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
We found this trial at
1
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San Francisco, California 94143
Phone: 415-353-4285
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