Clinical trial NCT03477682: Postoperative Management of Groin Flaps for Vascular Coverage
Official title: Postoperative Management of Groin Flaps for Vascular Coverage
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Functional Status After Sartorius Flap of the Groin
Wound Complication
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2018-03-26
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in AM-PAC Score
timeFrame: 1 week
Secondary outcomes:
measure: Wound infection requiring medication
timeFrame: 3 months
measure: Superficial wound dehiscence
timeFrame: 3 months
measure: Deep wound dehiscence
timeFrame: 3 months
measure: Wound infection requiring surgery
timeFrame: 3 months
measure: Length of hospital stay
timeFrame: 2 weeks
measure: Rehabilitation
timeFrame: 3 months
measure: SF36 Score
timeFrame: 3 months
measure: C-reactive protein
timeFrame: 1 week. Depending on the assigned group, this will be either on postoperative day two or six.
measure: Albumin
timeFrame: 1 week. Depending on the assigned group, this will be either on postoperative day two or six.
measure: Pre-albumin
timeFrame: 1 week. Depending on the assigned group, this will be either on postoperative day two or six.
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Scott L Hansen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.