Trial · NCT07896239
Antibiotic Tissue Penetration and Tissue Response in Head and Neck Infection and Reconstructive Surgery
NCT07896239, Phase 4, Recruiting, Tejs Ehlers Klug
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Antibiotic Tissue Penetration and Tissue Response in Head and Neck Infection and Reconstructive Surgery. Trials, record NCT07896239. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07896239
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Antibiotic Tissue Penetration and Tissue Response in Head and Neck Infection and Reconstructive Surgery
- NCT number
- NCT07896239
- Status
- Recruiting
- Phases
- Phase 4
- Enrollment
- 16 participants, estimated
- Lead sponsor
- Tejs Ehlers Klug
- Conditions
- Surgical Wound Infection, Neck Infection, Nasal Reconstruction
- Interventions
- Cefuroxime, Dicloxacillin, Cloxacillin, Amoxicillin/Clavulanic Acid, Microdialysis and serial blood sampling
- First posted
- 2026-10-26
- Last updated
- 2026-11-04
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time Above the Minimal Inhibitory Concentration (T>MIC) in Tissue and Plasma | Sub-study 1: two consecutive dosing intervals on day 2 (0-6 hours and 0-8 hours after dosing). Sub-study 2: one dosing interval (approximately 8 hours) after the morning dose on postoperative day 2. | Time during which the free concentration of each study antibiotic (cefuroxime, cloxacillin, dicloxacillin, and amoxicillin/clavulanic acid) exceeds the minimal inhibitory concentration in each measured tissue (microdialysis) and in plasma (serial blood samples), calculated from concentration-time profiles. Pre-specified MIC targets: cefuroxime 4 mg/L; cloxacillin 2 mg/L; dicloxacillin 2 mg/L; amoxicillin/clavulanic acid 2 mg/L (amoxicillin component). Reported as time (hours) and as percentage of the dosing interval. |
| Secondary | Area Under the Concentration-Time Curve (AUC) in Tissue and Plasma | Sub-study 1: two consecutive dosing intervals on day 2 (0-6 hours and 0-8 hours after dosing). Sub-study 2: one dosing interval (approximately 8 hours) after the morning dose on postoperative day 2. | AUC of the free concentration of each study antibiotic in each measured tissue compartment (microdialysis) and in plasma. |
| Secondary | Tissue Penetration Ratio (AUC Tissue / AUC Plasma) | Sub-study 1: two consecutive dosing intervals on day 2 (0-6 hours and 0-8 hours after dosing). Sub-study 2: one dosing interval (approximately 8 hours) after the morning dose on postoperative day 2. | Ratio of the AUC of the free antibiotic concentration in each tissue compartment to the AUC in plasma, for each study antibiotic. |
| Secondary | Maximum Concentration (Cmax) in Tissue and Plasma | Sub-study 1: two consecutive dosing intervals on day 2 (0-6 hours and 0-8 hours after dosing). Sub-study 2: one dosing interval (approximately 8 hours) after the morning dose on postoperative day 2. | Peak free concentration of each study antibiotic in each measured tissue compartment and in plasma. |
| Secondary | Time to Maximum Concentration (Tmax) in Tissue and Plasma | Sub-study 1: two consecutive dosing intervals on day 2 (0-6 hours and 0-8 hours after dosing). Sub-study 2: one dosing interval (approximately 8 hours) after the morning dose on postoperative day 2. | Time from dose administration to peak free concentration of each study antibiotic in each measured tissue compartment and in plasma. |
| Secondary | Elimination Half-Life (T1/2) in Tissue and Plasma | Sub-study 1: two consecutive dosing intervals on day 2 (0-6 hours and 0-8 hours after dosing). Sub-study 2: one dosing interval (approximately 8 hours) after the morning dose on postoperative day 2. | Elimination half-life of each study antibiotic in each measured tissue compartment and in plasma, derived from the concentration-time profiles. |
| Secondary | Lactate/Pyruvate Ratio in the Inferior Turbinate Flap | Hourly during the first 6 postoperative hours (day 1), and in the morning and evening of postoperative day 2. | Lactate/pyruvate ratio measured in microdialysate from the inferior turbinate flap and the nasal septal reference tissue, as a marker of tissue ischemia (sub-study 2). |
| Secondary | Tissue Ischemia Markers (Glucose, Lactate, Pyruvate, and Glycerol) | Sub-study 2: hourly during the first 6 postoperative hours (day 1), and in the morning and evening of postoperative day 2. Sub-study 1: during the sampling period on day 2 (up to approximately 14 hours). | Concentrations of glucose, lactate, pyruvate, and glycerol in microdialysate from the measured tissue compartments. |
| Secondary | Inflammatory Proteins in Microdialysate | Hourly during the first 6 postoperative hours (day 1), and in the morning and evening of postoperative day 2. | Levels of inflammatory proteins measured in microdialysate from the inferior turbinate flap and the nasal septal reference tissue, to characterize the early postoperative inflammatory tissue response (sub-study 2). |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07896239
GET https://conductscience.org/api/trials/v1/NCT07896239/registered