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OpenTrials
Completed

NCT Number: NCT04069650

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

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.

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Key information

Conditions

Free Flap Reconstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu Dijon Bourgogne

Dijon, 21000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • unable to give consent

Treatment and study plan

Free flap

Procedure

Free flap reconstruction of the oral cavity

Primary outcomes

  1. Major complication occurency

    Time frame: 1 month

    in the first-month post-operative period, complications leading to flap loss

Secondary outcomes

  1. Minor complication occurency

    Time frame: 1 month

    in the first-month post-operative period, complications NOT leading to flap loss

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Acronym: FOOD

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Aug 28, 2019
Registry last updated
Aug 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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