Malnutrition is Not a Risk Factor for Free Flap Failure in the Oral Cavity

Free Flap Reconstruction Clinical Trial

— FOOD  

Official title:

Malnutrition is Not a Risk Factor for Free Flap Failure in the Oral Cavity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04069650
• Other study ID #: ZWETYENGA 2018
• Status: Completed
• Start date: February 1, 2018
• Est. completion date: June 30, 2018

Study information

• Verified date: August 2019
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Free flap reconstruction consists in replacing tissular defect from one body part by another tissu harvested in a distant site. Microsurgery has to be performed to restore vascularization.

Free flaps are now the gold standard in complex reconstruction. While reliable with a success rate superior to 95 %, a failure takes a heavy burden on the patient. Many risk factors have been highlitghted in free flap failure for head and neck microvascular reconstruction.

Among them, malnutrition is still debated. This is a retrospective cohort study comparing complications occurrence between two groups. One group with normal nutritionnal status, the other with malnutrition. Between january 2008 and january 2018, 70 patients who underwent oral cavity reconstruction using free flap were included. This is the first study known to date which uses clinical and biological variables to determine the nutritionnal status.

Malnutrition is not associated with a higher risk for free flap failure in the oral cavity.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: June 30, 2018
• Est. primary completion date: May 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• every consenting patients undergoing free flap reconstruction of the oral cavity

Exclusion Criteria:

• unable to give consent

Related Conditions & MeSH terms

• Free Flap Reconstruction
• Malnutrition

Intervention

Procedure:
• Free flap
Free flap reconstruction of the oral cavity

Locations

Country	Name	City	State
France	Chu Dijon Bourgogne	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major complication occurency	in the first-month post-operative period, complications leading to flap loss	1 month
Secondary	Minor complication occurency	in the first-month post-operative period, complications NOT leading to flap loss	1 month