Functional Status After Sartorius Flap of the Groin, Wound Complication
Conditions
Brief 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.
Interventions
OTHEREarly 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).
Sponsors
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)
Masking description
The plastic surgeon who performs the sartorius flap does not know which group the patient will be randomized to (early ambulation versus standard 5 days bedrest) until after the surgery is completed.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in AM-PAC Score | 1 week | AMPAC Score measures functional status |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Superficial wound dehiscence | 3 months | 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. |
| Deep wound dehiscence | 3 months | 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. |
| Wound infection requiring surgery | 3 months | Wound infection or abscess requiring surgery (debridement, incision and drainage, exploration) |
| Length of hospital stay | 2 weeks | Length of hospitalization following surgery, measured in days |
| Wound infection requiring medication | 3 months | Described infection requiring antibiotics only, no surgery |
| SF36 Score | 3 months | 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. |
| C-reactive protein | 1 week. Depending on the assigned group, this will be either on postoperative day two or six. | A measure of nutritional status, measured on first day of mobilization |
| Albumin | 1 week. Depending on the assigned group, this will be either on postoperative day two or six. | A measure of nutritional status, measured on first day of mobilization |
| Pre-albumin | 1 week. Depending on the assigned group, this will be either on postoperative day two or six. | A measure of nutritional status, measured on first day of mobilization |
| Rehabilitation | 3 months | Type of rehabilitation after surgery (home health, skilled nursing facility, home physical therapy, none) |
Countries
United States
Outcome results
None listed