Development of a Predictive Score for Local Complications of Femoral Bifurcation Surgery (PROFA)

Development of a Predictive Score for Local Complications of Femoral Bifurcation Surgery: Prospective Multicenter Cohort Study

No prospective study has yet evaluated the factors influencing the complications of femoral bifurcation surgery in France. Daily practice of investigators suggests that conventional surgical treatment has had a higher rate of local complications in recent years for a variety of reasons that remain to be assessed (aging, overweight, chronic renal failure, diabetes, or other), but as of yet, investigators do not have proof of such an effect. The proposed study would follow a prospective, continuous, multicentre cohort of patients to describe the type, frequency and factors that contribute to local and general complications of surgery on the femoral bifurcation. This information is essential in the choice of the best revascularization technique for the femoral artery, which is frequently the site used for interventions in vascular conditions.

Surgeries will be performed in the normal manner. The research will be based on medical data collected during patient management. A measurement of the incision/scar will be taken once the procedure has been performed, either immediately after surgery or after a period of time, during post-operative consultation. Participation in this research will last 3 months from the day of the intervention.

Study Overview

• Status: Terminated
• Conditions: Femoral Bifurcation Surgery
• Intervention / Treatment: Other: Data collection; Other: Incision/scar measurement

• Study Type: Observational
• Enrollment (Actual): 163

Contacts and Locations

Study Locations

• France
  • Besançon, France
    • CHU Jean Minjoz
  • Colmar, France
    • CH Colmar
  • Dijon, France
    • CHU Dijon Bourgogne
  • Mulhouse, France
    • Ghr Mulhouse
  • Mâcon, France
    • CH Mâcon
  • Nancy, France
    • Chu Nancy
  • Troyes, France
    • CH Troyes

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Patients with a surgical approach to the common femoral artery or femoral tripod

Description

Inclusion Criteria:

• Patient who has not opposed participation in the study
• Age > 18 years old
• All patients with an open surgical approach to the common femoral artery and/or femoral bifurcation, uni or bilateral, with or without endovascular or open procedure

Exclusion Criteria:

• Patient with homolateral surgery of the femoral triangle which has not yet healed
• Person subject to court-ordered protection (curatorship, guardianship)
• Pregnant, parturient or breastfeeding woman
• Adult unable to consent
• Patient who refuses to participate in the study

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Presence of at least one of the following local complications: dehiscence alone, dehiscence with infection, superficial infection, deep infection, other (lymphorrhea, hematoma, lymphocele)	Between Day 0 and Day 90

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Dijon

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2019
• Primary Completion (Actual): March 2, 2020
• Study Completion (Actual): March 2, 2020

Study Registration Dates

• First Submitted: December 4, 2018
• First Submitted That Met QC Criteria: December 10, 2018
• First Posted (Actual): December 11, 2018

Study Record Updates

• Last Update Posted (Actual): July 1, 2024
• Last Update Submitted That Met QC Criteria: June 28, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: STEINMETZ 2018

Drug and device information, study documents

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