Postoperative Management of Groin Flaps for Vascular Coverage

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Postoperative Management of Groin Flaps for Vascular Coverage

Conditions
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Functional Status After Sartorius Flap of the Groin, Wound Complication

Intervention / Treatment
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* Other: Early ambulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early Ambulation Group<br>The patient will remain on bed rest for one day following surgery and will be encouraged to be out of bed and ambulating on the second day following surgery. | Other: Early ambulation<br>* 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).<br>|
| No Intervention: Standard Group<br>The patient will remain on bed rest for five days following surgery and will be encouraged to be out of bed and ambulating on the sixth day following surgery. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in AM-PAC Score | AMPAC Score measures functional status | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound infection requiring medication | Described infection requiring antibiotics only, no surgery | 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. | 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. | 3 months | 
| Wound infection requiring surgery | Wound infection or abscess requiring surgery (debridement, incision and drainage, exploration) | 3 months | 
| Length of hospital stay | Length of hospitalization following surgery, measured in days | 2 weeks | 
| Rehabilitation | Type of rehabilitation after surgery (home health, skilled nursing facility, home physical therapy, none) | 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. | 3 months | 
| C-reactive protein | A measure of nutritional status, measured on first day of mobilization | 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 | 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 | 1 week. Depending on the assigned group, this will be either on postoperative day two or six. |