Evaluating the vulnerability of traditional and transposition FAMM flaps using microdialysis

Evaluating the vulnerability of traditional and transposition FAMM flaps using microdialysis - FAMM study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2022-003858-31-DK

Enrollment

Registered

2023-01-25

Start date

2023-02-16

Completion date

Unknown

Last updated

2025-02-10

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

Conditions

Oral cavity cancer and infection

Interventions

Trade Name: Cefuroxime Product Name: Cefuroxim "Fresenius Kabi" Product Code: 25066 Pharmaceutical Form: Powder and solvent for concentrate for solution for infusion INN or Proposed INN: Cefuroxime CA

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Written informed consent - planned revision surgery with either the conventional or transposition FAMM flap following surgery for oral cavity cancer. - Age above 18 - Fertile women have to show a negative pregnancy test before enrollment. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 12 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 12

Exclusion criteria

Exclusion criteria: - Allergy to cefuroxime or metronidazole

Design outcomes

Primary

Measure	Time frame
Main Objective: The main objectives is: 1) To compare ischemic metabolites between conventional and transposition FAMM Flap. 2) To compare inflammation proteins between conventional and transposition FAMM Flap. 3) To compare concentrations of metronidazole and cefuroxime between conventional and transposition FAMM Flap. 4) To compare concentrations of metronidazole following per oral and intravenous use. 5) To compare concentrations of cefuroxime concentrations bolus and continuous infusion.;Secondary Objective: not applicable;Primary end point(s): - The time for which the cefuroxime concentration is maintained above the minimal inhibitory concentration (T>MIC). - The metronidazole area under the concentration time curve above MIC (AUC/MIC) - Inflammation markers - Lactate/pyruvate ratio;Timepoint(s) of evaluation of this end point: At the end of the study	—

Measure

Time frame

Main Objective: The main objectives is: 1) To compare ischemic metabolites between conventional and transposition FAMM Flap. 2) To compare inflammation proteins between conventional and transposition FAMM Flap. 3) To compare concentrations of metronidazole and cefuroxime between conventional and transposition FAMM Flap. 4) To compare concentrations of metronidazole following per oral and intravenous use. 5) To compare concentrations of cefuroxime concentrations bolus and continuous infusion.;Secondary Objective: not applicable;Primary end point(s): - The time for which the cefuroxime concentration is maintained above the minimal inhibitory concentration (T>MIC). - The metronidazole area under the concentration time curve above MIC (AUC/MIC) - Inflammation markers - Lactate/pyruvate ratio;Timepoint(s) of evaluation of this end point: At the end of the study

—

Secondary

Measure	Time frame
Secondary end point(s): - AUC - tissue penetration (AUCtissue/AUCplasma) - T1/2 - Cmax - Tmax - laktat glycerol, pyruvat og glucose;Timepoint(s) of evaluation of this end point: at the end of the study	—

Countries

Denmark

Contacts

Public ContactPelle Hanberg

Aarhus University Hospital

pellehanberg@clin.au.dk

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026