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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04069650
Acronym
FOOD
Enrollment
70
Registered
2019-08-28
Start date
2018-02-01
Completion date
2018-06-30
Last updated
2019-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Free Flap Reconstruction

Brief 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.

Interventions

PROCEDUREFree flap

Free flap reconstruction of the oral cavity

Sponsors

Centre Hospitalier Universitaire Dijon
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* unable to give consent

Design outcomes

Primary

MeasureTime frameDescription
Major complication occurency1 monthin the first-month post-operative period, complications leading to flap loss

Secondary

MeasureTime frameDescription
Minor complication occurency1 monthin the first-month post-operative period, complications NOT leading to flap loss

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026