Postoperative Management of Groin Flaps for Vascular Coverage

Not Applicable

Completed

• Conditions: Functional Status After Sartorius Flap of the Groin; Wound Complication
• Interventions: Other: Early ambulation

• Registration Number: NCT03477682
• Lead Sponsor: University of California, San Francisco

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.

Study Timeline

• Study Start: 2017-11-07
• Study First Submitted: 2018-03-05
• Study First Submitted QC: 2018-03-19
• Study First Posted: 2018-03-26
• Primary Completion: 2020-03-25
• Study Completion: 2021-06-30
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-15
• Last Update Posted: 2021-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early Ambulation Group	Early ambulation	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.

Primary Outcome Measures

Name	Time	Method
Change in AM-PAC Score	1 week	AMPAC Score measures functional status

Secondary Outcome Measures

Name	Time	Method
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
Rehabilitation	3 months	Type of rehabilitation after surgery (home health, skilled nursing facility, home physical therapy, none)
Wound infection requiring medication	3 months	Described infection requiring antibiotics only, no surgery
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.
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
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.

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States