Clinical Trial Results:
Evaluating the vulnerability of traditional and transposition FAMM flaps using microdialysis
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Summary
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EudraCT number |
2022-003858-31 |
Trial protocol |
DK |
Global end of trial date |
27 Jan 2025
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Results information
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Results version number |
v1(current) |
This version publication date |
18 May 2026
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First version publication date |
18 May 2026
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
300319
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Aarhus University Hospital
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Sponsor organisation address |
Palle Juul-Jensens Boulevard 99, Aarhus N, Denmark, 8200
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Public contact |
Pelle Hanberg, Aarhus University Hospital, pellehanberg@clin.au.dk
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Scientific contact |
Pelle Hanberg, Aarhus University Hospital, pellehanberg@clin.au.dk
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
27 Jan 2026
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
27 Jan 2025
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Global end of trial reached? |
Yes
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Global end of trial date |
27 Jan 2025
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
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.
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Protection of trial subjects |
The trial was conducted in accordance with the principles of Good Clinical Practice (GCP) and the Declaration of Helsinki.
All participants received both oral and written information about the study and were given adequate time to consider participation before providing written informed consent. Participation in the study was entirely voluntary, and participants were free to withdraw from the study at any time without any consequences for their further treatment.
The study protocol was approved by the relevant Ethics Committee and the national competent authority prior to initiation of the trial.
The interventions used in the study were based on standard clinical practice. The investigational procedures, including placement of microdialysis catheters, were considered to involve minimal additional risk. Potential risks and side effects, including those related to antibiotic treatment, were clearly described to participants.
All adverse events were monitored and managed according to standard clinical practice.
Personal data were handled confidentially and in compliance with applicable data protection regulations. Data were pseudonymised to protect participant identity.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Feb 2023
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Denmark: 24
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Worldwide total number of subjects |
24
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EEA total number of subjects |
24
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
12
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From 65 to 84 years |
12
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85 years and over |
0
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Recruitment
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Recruitment details |
Participants were recruited consecutively from patients scheduled for surgery for oral cavity cancer at Aarhus University Hospital. Eligible patients were identified during preoperative assessment, informed orally and in writing, and included after providing written informed consent. | |||||||||
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Pre-assignment
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Screening details |
Patients were screened during preoperative assessment for eligibility based on inclusion and exclusion criteria, including planned reconstruction with a FAMM flap, age ≥18 years, and absence of allergy to cefuroxime or metronidazole. | |||||||||
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Period 1
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Period 1 title |
Overall period
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | |||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Standard treatment | |||||||||
Arm description |
cefuroxime as bolus and metronidazole iv | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Cefuroxime
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Powder and solution for solution for injection
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Routes of administration |
Intravenous bolus use
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Dosage and administration details |
1500 mg as bolus dose over 5 min
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Investigational medicinal product name |
Metronidazole
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Powder and solvent for concentrate for solution for infusion
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Routes of administration |
Intravenous bolus use
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Dosage and administration details |
500 mg as bolus dose over 5 min
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Arm title
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New treatment | |||||||||
Arm description |
Cefuroxime continuous use and metronidazole po | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Cefuroxime
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Powder and solution for suspension for injection
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Routes of administration |
Intravenous drip use
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Dosage and administration details |
1500 mg given over 8 hours
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Investigational medicinal product name |
Metronidazole
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Oral liquid
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Routes of administration |
Oral use
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Dosage and administration details |
500 mg over 5 min
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Baseline characteristics reporting groups
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Reporting group title |
Overall period
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Standard treatment
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Reporting group description |
cefuroxime as bolus and metronidazole iv | ||
Reporting group title |
New treatment
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Reporting group description |
Cefuroxime continuous use and metronidazole po | ||
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End point title |
T>MIC | |||||||||
End point description |
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End point type |
Primary
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End point timeframe |
0-8 h
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Attachments |
Metronidazole transposition FAMM flap Cefuroxime conventional FAMM flap Cefuroxime transposition FAMM flap Metronidazole conventional FAMM flap |
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Statistical analysis title |
non-compartmental analysis in STATA | |||||||||
Comparison groups |
New treatment v Standard treatment
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Number of subjects included in analysis |
24
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Analysis specification |
Pre-specified
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Analysis type |
equivalence | |||||||||
P-value |
< 0.05 | |||||||||
Method |
ANOVA | |||||||||
Confidence interval |
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level |
95% | |||||||||
sides |
2-sided
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lower limit |
2.5 | |||||||||
upper limit |
97.2 | |||||||||
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Adverse events information [1]
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Timeframe for reporting adverse events |
from: 16/2-2023
To 27/1-2025
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Assessment type |
Systematic | |||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
none | |||||||||||||||
Dictionary version |
0
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Reporting groups
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Reporting group title |
standerd treatment
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Reporting group description |
- | |||||||||||||||
Reporting group title |
new treatment
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Reporting group description |
- | |||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 0% | ||||||||||||||||
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| Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: No adverse events were found for this study |
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
Online references |
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| http://www.ncbi.nlm.nih.gov/pubmed/42066992 http://www.ncbi.nlm.nih.gov/pubmed/41790509 http://www.ncbi.nlm.nih.gov/pubmed/41407330 |
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