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 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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
28
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).
University of California, San Francisco
San Francisco, California, United States
Change in AM-PAC Score
AMPAC Score measures functional status
Time frame: 1 week
Wound infection requiring medication
Described infection requiring antibiotics only, no surgery
Time frame: 3 months
Superficial wound dehiscence
Dehiscence of superficial layers (skin and subcutaneous tissue) requiring local wound care. Information will be gathered from medical record as charted by provider describing superficial wound dehiscence or via picture in the chart. This means separation at the skin level and may include, epidermis, dermis or subcutaneous fat or all three.
Time frame: 3 months
Deep wound dehiscence
Dehiscence of wound down to fascia, muscle, exposed vessels, requiring surgery. Information will be gathered from medical record as charted by provider or via picture. It will be described as wound dehiscence beyond the subcutaneous tissue down to fascia, muscle or exposed vessel and that required a re-operation by the plastic surgery team.
Time frame: 3 months
Wound infection requiring surgery
Wound infection or abscess requiring surgery (debridement, incision and drainage, exploration)
Time frame: 3 months
Length of hospital stay
Length of hospitalization following surgery, measured in days
Time frame: 2 weeks
Rehabilitation
Type of rehabilitation after surgery (home health, skilled nursing facility, home physical therapy, none)
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Time frame: 3 months
SF36 Score
This survey measures quality of life and will be used to examine the impact of bedrest on patient reported quality of life outcomes postoperatively. Total scores range from 0-100 with higher scores indicating a more favorable state.
Time frame: 3 months
C-reactive protein
A measure of nutritional status, measured on first day of mobilization
Time frame: 1 week. Depending on the assigned group, this will be either on postoperative day two or six.
Albumin
A measure of nutritional status, measured on first day of mobilization
Time frame: 1 week. Depending on the assigned group, this will be either on postoperative day two or six.
Pre-albumin
A measure of nutritional status, measured on first day of mobilization
Time frame: 1 week. Depending on the assigned group, this will be either on postoperative day two or six.