Evidence map›Paper›PMID 34727951›Full record

ArticleTrials2021

APOS-antibiotic prophylaxis for preventing infectious complications in orthognathic surgery: study protocol for a phase III, multicentre, randomised, controlled, double blinded, clinical trial with two parallel study arms.

Oliver Ristow, Christof Hofele, Philipp Münch, Sylvia Danner, Anja Dietzel, Johannes Krisam, Christina Klose, Maximilian Pilz, Jürgen Hoffmann, Christian Freudlsperger

Abstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Observational
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Oliver RistowDepartment of Oral and Maxillofacial Surgery, University of Heidelberg, Im Neuenheimer Feld 400, D-69120, Heidelberg, Germany. oliver.ristow@med.uni-heidelberg.de.ORCID http://orcid.org/0000-0002-3911-262X
Christof HofeleDepartment of Oral and Maxillofacial Surgery, University of Heidelberg, Im Neuenheimer Feld 400, D-69120, Heidelberg, Germany.
Philipp MünchDepartment of Oral and Maxillofacial Surgery, University of Heidelberg, Im Neuenheimer Feld 400, D-69120, Heidelberg, Germany.
Sylvia DannerCoordination Centre for Clinical Trials (KKS), University of Heidelberg, 69120, Heidelberg, Germany.
Anja DietzelCoordination Centre for Clinical Trials (KKS), University of Heidelberg, 69120, Heidelberg, Germany.
Johannes KrisamInstitute of Medical Biometry and Informatics, Department of Biometry, University of Heidelberg, Im Neuenheimer Feld 130.3, D-69120, Heidelberg, Germany.
Christina KloseInstitute of Medical Biometry and Informatics, Department of Biometry, University of Heidelberg, Im Neuenheimer Feld 130.3, D-69120, Heidelberg, Germany.
Maximilian PilzInstitute of Medical Biometry and Informatics, Department of Biometry, University of Heidelberg, Im Neuenheimer Feld 130.3, D-69120, Heidelberg, Germany.
Jürgen HoffmannDepartment of Oral and Maxillofacial Surgery, University of Heidelberg, Im Neuenheimer Feld 400, D-69120, Heidelberg, Germany.
Christian FreudlspergerDepartment of Oral and Maxillofacial Surgery, University of Heidelberg, Im Neuenheimer Feld 400, D-69120, Heidelberg, Germany.

Funding

Deutsche Forschungsgemeinschaft RI2813/3-1
6 · The paper itself

Abstract

backgroundIt is a constant debate among surgeons whether the use of prolonged postoperative antibiotics may reduce surgical site infection rates. As specific treatment guidelines are still lacking, many surgeons continue to use broad-spectrum antibiotics, causing not only increased costs but also contributing to the potential for antibiotic resistance. Hence, there is an urgent need for an appropriately designed prospective clinical trial, to investigate whether a prophylactic use of antibiotics after surgery actually decreases surgical site infections to a clinically relevant degree.

methodsThis study presents a multicentre, randomised, controlled, double-blinded, clinical trial with two parallel study arms to demonstrate that no postoperative antibiotic prophylaxis (AP) is not inferior to antibiotic prophylaxis with respect to surgical site infections in patients having undergone orthognathic surgery. The primary efficacy endpoint is defined as the occurrence of postoperative surgical site infections within 30 days of surgery. Secondary endpoints are further efficacy and subject-oriented parameters within 90 days after surgery. The entire trial is planned for 54 months, with an enrolment of 1420 patients over 39 months by 14 national participating centres. DISCUSSION: As a highly standardised procedure on an exceeding, healthy and young homogenous study population and identical processes all over the world, elective orthognathic surgery as clean-contaminated procedure provides comparable intervention groups with balanced baseline characteristics, comparable surgical duration, even when performed within multiple centres. Therefore, evaluating antibiotic prophylaxis after orthognathic surgery will be of high scientific value representable for other surgical procedures.

trial registrationDRKS-German Clinical Trials Register- DRKS00022838 ; EudraCT No. 2020-001397-30. Registered on 29 March 2021.

Indexed as

Antibiotic ProphylaxisOrthognathic SurgeryAnti-Bacterial AgentsHumansMulticenter Studies as TopicProspective StudiesRandomized Controlled Trials as TopicSurgical Wound InfectionAnti-Bacterial AgentsAntibiotic prophylaxisOrthognathic surgeryRandomised controlled trialSurgical site infection

Identifiers

PMID34727951
PMCPMC8561874

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.