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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03772821
Recruitment Status : Recruiting
First Posted : December 11, 2018
Last Update Posted : January 22, 2020
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon

Brief Summary:

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.


Condition or disease Intervention/treatment
Femoral Bifurcation Surgery Other: Data collection Other: Incision/scar measurement

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Study Type : Observational
Estimated Enrollment : 690 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Development of a Predictive Score for Local Complications of Femoral Bifurcation Surgery: Prospective Multicenter Cohort Study
Actual Study Start Date : January 8, 2019
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : April 2022

Intervention Details:
  • Other: Data collection
    Between D0 and D90: local and general complications, demographic, clinical, paraclinical and biological data
  • Other: Incision/scar measurement
    Between D0 and D90


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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with a surgical approach to the common femoral artery or femoral tripod
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03772821


Contacts
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Contact: Eric STEINMETZ 03 80 29 33 52 eric.steinmetz@chu-dijon.fr
Contact: Aline JAZAYERI aline.laubriet@chu-dijon.fr

Locations
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France
CHU Jean Minjoz Recruiting
Besançon, France
Contact: Simon RINCKENBACH    03 81 66 82 27      
CH Colmar Recruiting
Colmar, France
Contact: Benjamin KRETZ    03 89 12 44 77      
CHU Dijon Bourgogne Recruiting
Dijon, France
Contact: Eric STEINMETZ    03 80 29 33 52    eric.steinmetz@chu-dijon.fr   
Contact: Aline JAZAYERI       aline.laubriet@chu-dijon.fr   
GHR Mulhouse Recruiting
Mulhouse, France
Contact: Afif GHASSANI    03 89 64 64 64      
CH Mâcon Recruiting
Mâcon, France
Contact: Nicolas CHRETIEN    07 87 23 94 53      
CHU Nancy Recruiting
Nancy, France
Contact: Nicla SETTEMBRE    03 83 15 43 84      
CH Troyes Recruiting
Troyes, France
Contact: Olivier MAHMANDAR    03 25 49 49 55      
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon
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Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT03772821    
Other Study ID Numbers: STEINMETZ 2018
First Posted: December 11, 2018    Key Record Dates
Last Update Posted: January 22, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No