NCT03477682

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 7, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 5, 2018

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 26, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2020

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

September 22, 2021

Status Verified

September 1, 2021

Enrollment Period

2.4 years

First QC Date

March 5, 2018

Last Update Submit

September 15, 2021

Conditions

Functional Status After Sartorius Flap of the GroinWound Complication

Outcome Measures

Primary Outcomes (1)

  • Change in AM-PAC Score

    AMPAC Score measures functional status

    1 week

Secondary Outcomes (10)

  • Wound infection requiring medication

    3 months

  • Superficial wound dehiscence

    3 months

  • Deep wound dehiscence

    3 months

  • Wound infection requiring surgery

    3 months

  • Length of hospital stay

    2 weeks

  • +5 more secondary outcomes

Study Arms (2)

Early Ambulation Group

EXPERIMENTAL

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

Standard Group

NO INTERVENTION

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.

Interventions

Early ambulationOTHER

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).

Early Ambulation Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients undergoing muscle flaps following infrainguinal, open vascular surgery. Patients must be ambulatory at baseline. Patients must be able to provide informed consent.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Related Publications (6)

  • 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.

    PMID: 21458203BACKGROUND

  • 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.

    PMID: 22209610BACKGROUND

  • 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.

    PMID: 22425834BACKGROUND

  • 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.

    PMID: 23831123BACKGROUND

  • 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.

    PMID: 8497530BACKGROUND

  • 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.

    PMID: 19234100BACKGROUND

MeSH Terms

Interventions

Early Ambulation

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeutics

Study Officials

  • Scott L Hansen, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2018

First Posted

March 26, 2018

Study Start

November 7, 2017

Primary Completion

March 25, 2020

Study Completion

June 30, 2021

Last Updated

September 22, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)