Postoperative InfectionPhase 4NCT02436083
Antibiotics in Free Flaps Reconstructions
A Phase 4 study testing antibiotic (use of penicilline, unacid, cefuroxime) in people with Postoperative Infection, run by Technical University of Munich.
Trial summary
The purpose of this study is to monitor and compare peri-operative problems and outcomes of reconstructive surgery with microvascular free flaps in the head and neck region between groups of patients treated with perioperative antibiotics and a group of patients without antibiotics. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Postoperative Infection
- What is being tested?
- antibiotic (use of penicilline, unacid, cefuroxime)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- No sites listed yet
- Study dates
- Jul 2007to Dec 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any patient who required reconstructive surgery for oncological reasons within the oral cavity with microvascular free flaps.
Who cannot join
- Healthy humans.
- Patients receiving preoperative neoadjuvant or previous adjuvant radiation therapy in their medical history.
About this study
Official title: The Value of Perioperative Antibiotics on the Success of Oral Free Flap Reconstructions
The purpose of this study is to monitor and compare peri-operative problems and outcomes of reconstructive surgery with microvascular free flaps in the head and neck region between groups of patients treated with perioperative antibiotics and a group of patients without antibiotics.
Read the detailed description
Study Design and Patient Recruitment All clinical investigations have been conducted according to the principles expressed in the Declaration of Helsinki. Patient consent was written. Any patient who required reconstructive surgery for oncological reasons within the oral cavity with microvascular free flaps was eligible. Patients receiving preoperative neoadjuvant or previous adjuvant radiation therapy in their medical history were not included in this study as the protocols available are not comparable in doses and effect on the irradiated tissue.14 A prospective study was initiated from July of 2007 to June 2012. All patients were prospectively evaluated.
Postoperative Care The investigators standard regimen was to keep the patient sedated for one night on the intensive care unit and then transfer to the surgical ward. The specific intravenous antibiotic therapy was started 30 minutes before the operation and administered for 10 days.
Data Analysis Recorded parameters included: age, sex, preoperative medical history, American society of Anesthesiologists classification of preoperative status 15, diagnosis, stage of disease, defect localisation, type of microvascular free flap, choice of recipient vessels, flap success, rate and number of operative revisions, primary or secondary reconstruction, type of previous treatment (radiation or surgery), type of previous neck dissection (if any), microvascular complications, the total operative time, wound healing disturbances subdivided into dehiscence and infection at the neck, region of reconstruction, or donor site, and prophylactic antibiotic agent, if used. Infection was defined as a purulent discharge at the wounds.
Descriptive statistics for quantitative variables are given as the mean ± standard deviation. The data were analyzed with the "Statistical Package for the Social Sciences" software (IBM® SPSS® Statistics for Windows, Version 22.0; IBM Corp., Armonk, NY, USA). Figures are generated with SPSS and Microsoft® Office Excel (Microsoft Excel for Windows, release 11.0, 2003, Microsoft Corporation, Redmond, WA, USA). Multiple linear regression analyses were used to determine factors independently associated with the dependent variable wound infection or wound healing disturbances. 95% confidence intervals (95% CI) are also given. Differences were considered to be statistically significant for a two-sided p-value of less than 0.05.
- Conditions
- Postoperative Infection
- Being tested
- antibiotic (use of penicilline, unacid, cefuroxime)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
antibiotic (use of penicilline, unacid, cefuroxime)Drug
Also called use of penicilline, unacid, cefuroxime
prophylactic antibiotics
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | no antibiotics |
| experimental group | Active comparator | drug administration (antibiotic) Receives: Drug: antibiotic (use of penicilline, unacid, cefuroxime) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequencies of wound infection detected by clinical examinations (daily for 2 weeks, 2 times per week afterwards)
Measured: participants will be followed for the duration of hospital stay (2 weeks) and a total of 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2015 (estimated)
- Study startJul 2007
- Primary completionJun 2012
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, thomas.muecke, Technical University of Munich
- Investigators
- Denys J Loeffelbein, MD, DDS, PhD, Study chair, Department of Oral and Maxillofacial Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02436083
- Sponsor's protocol ID
- MKG-2007
- Status last verified
- May 2015
- First submitted
- 9 Mar 2015
- Last updated
- 6 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Mucke T, Rohleder NH, Rau A, Ritschl LM, Kesting M, Wolff KD, Mitchell DA, Loeffelbein DJ. The value of perioperative antibiotics on the success of oral free flap reconstructions. Microsurgery. 2015 Oct;35(7):507-11. doi: 10.1002/micr.22470. Epub 2015 Aug 7.
PubMed 26251066
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of Perioperative Antibiotics on the Success of Oral Free Flap Reconstructions
- ClinicalTrials.gov ID
- NCT02436083
- Acronym / sponsor ID
- MKG-2007
- Conditions
- Postoperative Infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Jun 2012 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 6 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to monitor and compare peri-operative problems and outcomes of reconstructive surgery with microvascular free flaps in the head and neck region between groups of patients treated with perioperative antibiotics and a group of patients without antibiotics.
Detailed description
Study Design and Patient Recruitment All clinical investigations have been conducted according to the principles expressed in the Declaration of Helsinki. Patient consent was written. Any patient who required reconstructive surgery for oncological reasons within the oral cavity with microvascular free flaps was eligible. Patients receiving preoperative neoadjuvant or previous adjuvant radiation therapy in their medical history were not included in this study as the protocols available are not comparable in doses and effect on the irradiated tissue.14 A prospective study was initiated from July of 2007 to June 2012. All patients were prospectively evaluated.
Postoperative Care The investigators standard regimen was to keep the patient sedated for one night on the intensive care unit and then transfer to the surgical ward. The specific intravenous antibiotic therapy was started 30 minutes before the operation and administered for 10 days.
Data Analysis Recorded parameters included: age, sex, preoperative medical history, American society of Anesthesiologists classification of preoperative status 15, diagnosis, stage of disease, defect localisation, type of microvascular free flap, choice of recipient vessels, flap success, rate and number of operative revisions, primary or secondary reconstruction, type of previous treatment (radiation or surgery), type of previous neck dissection (if any), microvascular complications, the total operative time, wound healing disturbances subdivided into dehiscence and infection at the neck, region of reconstruction, or donor site, and prophylactic antibiotic agent, if used. Infection was defined as a purulent discharge at the wounds.
Descriptive statistics for quantitative variables are given as the mean ± standard deviation. The data were analyzed with the "Statistical Package for the Social Sciences" software (IBM® SPSS® Statistics for Windows, Version 22.0; IBM Corp., Armonk, NY, USA). Figures are generated with SPSS and Microsoft® Office Excel (Microsoft Excel for Windows, release 11.0, 2003, Microsoft Corporation, Redmond, WA, USA). Multiple linear regression analyses were used to determine factors independently associated with the dependent variable wound infection or wound healing disturbances. 95% confidence intervals (95% CI) are also given. Differences were considered to be statistically significant for a two-sided p-value of less than 0.05.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | –no antibiotics |
| experimental group | Active comparator | Drug: antibiotic (use of penicilline, unacid, cefuroxime)drug administration (antibiotic) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any patient who required reconstructive surgery for oncological reasons within the oral cavity with microvascular free flaps.
Key exclusion criteria (2 listed)
- Healthy humans.
- Patients receiving preoperative neoadjuvant or previous adjuvant radiation therapy in their medical history.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| antibiotic (use of penicilline, unacid, cefuroxime)Also: use of penicilline, unacid, cefuroximeprophylactic antibiotics | Drug | experimental group |
Primary outcome
Frequencies of wound infection detected by clinical examinations (daily for 2 weeks, 2 times per week afterwards)
Time frame: participants will be followed for the duration of hospital stay (2 weeks) and a total of 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2015.
- Derived from this study: PubMed 26251066Mucke T, Rohleder NH, Rau A, Ritschl LM, Kesting M, Wolff KD, Mitchell DA, Loeffelbein DJ. The value of perioperative antibiotics on the success of oral free flap reconstructions. Microsurgery. 2015 Oct;35(7):507-11. doi: 10.1002/micr.22470. Epub 2015 Aug 7.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Denys J Loeffelbein, MD, DDS, PhD study chair
Department of Oral and Maxillofacial Surgery
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing antibiotic (use of penicilline, unacid, cefuroxime) in people with Postoperative Infection, run by Technical University of Munich.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequencies of wound infection detected by clinical examinations (daily for 2 weeks, 2 times per week afterwards) (time frame: participants will be followed for the duration of hospital stay (2 weeks) and a total of 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02436083, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2015.