NCT04399044

Brief Summary

Previous studies have suggested that prophylactic muscle coverage in high-risk patients undergoing revascularization procedures through a groin incision have the potential to reduce rates of complications and re-operation. This is a prospective randomized control trial to test this hypothesis at the University of Wisconsin Hospitals and Clinics.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

May 18, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 22, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

October 16, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 26, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 26, 2021

Completed
Last Updated

June 27, 2024

Status Verified

June 1, 2024

Enrollment Period

4 months

First QC Date

May 18, 2020

Last Update Submit

June 26, 2024

Conditions

Vascular Graft Infection

Outcome Measures

Primary Outcomes (1)

  • Incidence of Graft Infection Requiring Re-operation

    Infection of the vascular graft as determined by clinical diagnosis which requires re-operation for washout or other indicated procedures

    within 1 year

Secondary Outcomes (12)

  • Incidence of Infection Not Requiring Re-operation

    1 year

  • Incidence of Seroma

    1 year

  • Incidence of Lymphocele

    1 year

  • Incidence of Wound Dehiscence

    1year

  • Toronto Lower Extremity Salvage Score (TESS) at 3 months

    3 months

  • +7 more secondary outcomes

Study Arms (2)

Group 1: No flap

NO INTERVENTION

Participants will undergo the scheduled vascular surgery procedure without involvement of the plastic surgery team and use of muscle flaps for graft coverage.

Group 2: Prophylactic muscle flap

EXPERIMENTAL

Participants will undergo the scheduled vascular surgery procedure and then a muscle flap will be used to cover the vascular graft by a plastic surgeon in the same setting.

Procedure: Prophylactic muscle flap

Interventions

Prophylactic muscle flapPROCEDURE

A "muscle flap" refers to taking an expendable muscle with its vascular supply and moving it to a new area. In this case, the investigators will take a muscle from the leg or abdomen that is redundant (other muscles perform the same function) and moving it to cover vascular grafts to provide healthy tissue to prevent infection.

Group 2: Prophylactic muscle flap

Eligibility Criteria

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

You may qualify if:

  • Open lower extremity arterial revascularization
  • Groin incision
  • "High-risk" patients based on risk calculation

You may not qualify if:

  • Pregnant or breast-feeding
  • Any person with diagnosis of an active groin infection preoperatively
  • Incarcerated patients
  • Unstable patients going directly to the OR for whom the study consent process would delay care, and those who cannot give informed consent to participate in the research study will be excluded
  • If a surgeon feels that a patient should or should not receive a flap based on intra-operative or pre-operative characteristics, those patients will be excluded from the study
  • Prior to a scheduled groin intervention case a prior authorization will be sent to the participant's insurance company. If the groin flap is denied, which would be highly unusual, then the participant would be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53704, United States

Location

Related Publications (3)

  • Fischer JP, Nelson JA, Rohrbach JI, Wu LC, Woo EY, Kovach SJ, Low DW, Serletti JM, Kanchwala S. Prophylactic muscle flaps in vascular surgery: the Penn Groin Assessment Scale. Plast Reconstr Surg. 2012 Jun;129(6):940e-949e. doi: 10.1097/PRS.0b013e31824ecb17.

    PMID: 22327893BACKGROUND

  • Fischer JP, Nelson JA, Shang EK, Wink JD, Wingate NA, Woo EY, Jackson BM, Kovach SJ, Kanchwala S. Predicting the need for muscle flap salvage after open groin vascular procedures: a clinical assessment tool. J Plast Surg Hand Surg. 2014 Dec;48(6):389-95. doi: 10.3109/2000656X.2014.899242. Epub 2014 Mar 25.

    PMID: 24666001BACKGROUND

  • Bennett KM, Levinson H, Scarborough JE, Shortell CK. Validated prediction model for severe groin wound infection after lower extremity revascularization procedures. J Vasc Surg. 2016 Feb;63(2):414-9. doi: 10.1016/j.jvs.2015.08.094. Epub 2015 Oct 30.

    PMID: 26526055BACKGROUND

Study Officials

  • Katherine Gast, MD

    University of Wisconsin, Madison

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2020

First Posted

May 22, 2020

Study Start

October 16, 2020

Primary Completion

February 26, 2021

Study Completion

February 26, 2021

Last Updated

June 27, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)