Postoperative Management of Groin Flaps for Vascular Coverage

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.

Study Overview

• Status: Completed
• Conditions: Wound Complication; Functional Status After Sartorius Flap of the Groin
• Intervention / Treatment: Other: Early ambulation

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 Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • University of California, San Francisco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early Ambulation Group; 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; 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).
No Intervention: Standard Group; 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?

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.

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Investigators: Principal Investigator: Scott L Hansen, MD, University of California, San Francisco

Publications and helpful links

General Publications

• Greenblatt DY, Rajamanickam V, Mell MW. Predictors of surgical site infection after open lower extremity revascularization. J Vasc Surg. 2011 Aug;54(2):433-9. doi: 10.1016/j.jvs.2011.01.034. Epub 2011 Mar 31.
• Fischer JP, Nelson JA, Mirzabeigi MN, Wang GJ, Foley PJ 3rd, Wu LC, Woo EY, Kanchwala S. Prophylactic muscle flaps in vascular surgery. J Vasc Surg. 2012 Apr;55(4):1081-6. doi: 10.1016/j.jvs.2011.10.110. Epub 2011 Dec 29.
• Genc A. Early mobilization of the critically ill patients: towards standardization. Crit Care Med. 2012 Apr;40(4):1346-7. doi: 10.1097/CCM.0b013e31823b8e44. No abstract available.
• Fischer JP, Mirzabeigi MN, Sieber BA, Nelson JA, Wu LC, Kovach SJ, Low DW, Serletti JM, Kanchwala S. Outcome analysis of 244 consecutive flaps for managing complex groin wounds. J Plast Reconstr Aesthet Surg. 2013 Oct;66(10):1396-404. doi: 10.1016/j.bjps.2013.06.014. Epub 2013 Jul 5.
• Evans GR, Francel TJ, Manson PN. Vascular prosthetic complications: success of salvage with muscle-flap reconstruction. Plast Reconstr Surg. 1993 Jun;91(7):1294-302.
• Perme C, Chandrashekar R. Early mobility and walking program for patients in intensive care units: creating a standard of care. Am J Crit Care. 2009 May;18(3):212-21. doi: 10.4037/ajcc2009598. Epub 2009 Feb 20.

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2017
• Primary Completion (Actual): March 25, 2020
• Study Completion (Actual): June 30, 2021

Study Registration Dates

• First Submitted: March 5, 2018
• First Submitted That Met QC Criteria: March 19, 2018
• First Posted (Actual): March 26, 2018

Study Record Updates

• Last Update Posted (Actual): September 22, 2021
• Last Update Submitted That Met QC Criteria: September 15, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 15-17005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No