Profilaxis antibi�tica de esquema largo comparado con esquema corto en pacientes sometidos a cirug�a ortogn�tica

Wallach , Matthias; Cu�llar, Javier; Verdugo-Paiva, Francisca; Alarc�n, Ana

doi:10.5867/medwave.2020.11.8071

Res�menes Epistemonikos

Medwave 2020;20(11):e8071 doi: 10.5867/medwave.2020.11.8071

Profilaxis antibi�tica de esquema largo comparado con esquema corto en pacientes sometidos a cirug�a ortogn�tica

Long-term antibiotic prophylaxis regimen compared to short-term antibiotic prophylaxis regimen in patients undergoing orthognathic surgery

Matthias Wallach , Javier Cu�llar, Francisca Verdugo-Paiva, Ana Alarc�n

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Palabras clave: orthognathic surgery, long term antibiotic prophylaxis, short term antibiotic prophylaxis, Epistemonikos, GRADE.

Abstract

INTRODUCTION
Orthognathic surgery, being an invasive surgical procedure, may present significant postoperative morbidities for the patient. Among the most frequently described complications is surgical site infection. The administration of prophylactic antibiotics prior to this type of procedure is a common practice, however, the cost-benefit of the use of antibiotics, the type of antibiotics, the route of administration, the dosage, and the regimen to be used have not been clearly defined and are still considered a controversial issue. In this summary of evidence, we will compare long-term antibiotic prophylaxis with short-term prophylaxis.

METHODS
We searched in Epistemonikos, the largest database of systematic reviews in health, which is maintained by screening multiple information sources, including MEDLINE, EMBASE, Cochrane, among others. We extracted data from the systematic reviews, reanalyzed data of primary studies, conducted a meta-analysis and generated a summary of findings table using the GRADE approach.

RESULTS AND CONCLUSIONS
We identified five systematic reviews including nine studies overall, of which all nine were randomized trials. We conclude that administering a long-term prophylactic antibiotic regimen probably decreases the risk of surgical site infection and that it may increase the risk of hospital stay longer than two days, nevertheless, regarding this last point, the certainty of the evidence is low.

Problem

Orthognathic surgery corresponds to a set of surgical techniques that allow the correction of the anomalies of the maxillofacial complex through the realignment of the maxillary and mandibular bones; allowing the improvement of the functionality, facial harmony, and aesthetics. Some of the postoperative complications include hemorrhage, temporary or permanent neurological alterations and infections. In relation to this last complication, the use of antibiotic prophylaxis is frequent, and is defined as the use of antibiotics to prevent infection at the surgical site [1]. However, there is no clear consensus regarding the type of antibiotic, dose, route of administration or regimen to use.

Additionally, prophylactic antibiotic schedules can be classified according to the time of administration:

Preoperative prophylaxis: a single dose before surgery.
Short-term prophylactic antibiotic regimen: begins with pre-surgical doses and is maintained for and/or up to 24 hours after surgery.
Long-term prophylactic antibiotic regimen: starts with pre-surgical doses and is maintained for and beyond 24 hours after surgery [1].

In this summary of evidence, the long-term and short-term prophylactic antibiotic regimen will be comparatively evaluated, with the intention of clarifying which of these would be more effective in reducing postoperative complications.

Methods

We searched in Epistemonikos, the largest database of systematic reviews in health, which is maintained by screening multiple information sources, including MEDLINE, EMBASE, Cochrane, among others, to identify systematic reviews and their included primary studies. We extracted data from the identified reviews and reanalyzed data from primary studies included in those reviews. With this information, we generated a structured summary denominated FRISBEE (Friendly Summary of Body of Evidence using Epistemonikos) using a pre-established format, which includes key messages, a summary of the body of evidence (presented as an evidence matrix in Epistemonikos), meta-analysis of the total of studies when it is possible, a summary of findings table following the GRADE approach and a table of other considerations for decision-making.

Key messages

Administering a long-term antibiotic prophylaxis regimen, compared to administering a short-term antibiotic prophylaxis regimen probably decreases the risk of surgical site infection.
Administering a long-term prophylactic antibiotic regimen, compared to administering a short-term prophylactic antibiotic regimen, may increase hospital stay longer than two days (low certainty of evidence).
No studies were found that looked at mortality, systemic infection and adverse effects.

About the body of evidence for this question

What is the evidence. See evidence matrix in Epistemonikos later	We identified five systematic reviews [1], [2], [3], [4], [5] including nine studies overall [6], [7], [8], [9], [10], [11], [12], [13], [14], of which all were randomized trials.
What types of patients were included*	All trials included patients that underwent orthognathic surgery, without distinction in the subtype of surgery. The trials included men and women with ages ranging from 15 to 48 years [6], [7], [8], [9], [10], [11], [12], [13], [14].
What types of interventions were included*	All trials evaluated long antibiotic prophylaxis regimens compared with short prophylaxis regimens. Long-term prophylactic regimens considered administration of antibiotics before the operation, on the day of the surgery, and for several additional postoperative days: two days [7], [13],12 three days 12], five days [6], [11], seven days [10], [14]. This information was not reported in two trials [8], [9]. Short-term prophylactic antibiotic regimens considered preoperative and during the same day (up to 24 hrs.) antibiotic administration [6], [7], [8], [9], [10], [11], [12], [13], [14]. Three trials used placebo within the regimen [6], [7], [13]. The antibiotics used by each trial were: Cefpiramide [12] Penicillin G [7], [10], [11], [13], [14] Penicillin V [7] Amoxicillin [6] Amoxicillin and clavulanic acid [11] Clindamycin [6], [10] (only in patients presenting penicillin allergy) The routes of drug administration used were Endovenous: [12] Intramuscular and intravenous [13] Endovenous and oral [6], [7], [10], [11], [14] Two trials did not report the regimen, antibiotic or route of administration used [8], [9].
What types of outcomes were measured	The trials evaluated multiple outcomes, which were grouped by the systematic reviews as follows: Surgical Site Infection Hospital Stay The average follow-up of the trials was nine weeks with a range of four to 24 weeks..

* Information about primary studies is not extracted directly from primary studies but from identified systematic reviews, unless otherwise stated.

Summary of findings

The information on the effects of antibiotic prophylaxis in a long-term regimen is based on nine randomized trials [6], [7], [8], [9], [10], [11], [12], [13], [14], involving 472 patients.Nine trials measured the outcome surgical site infection [6], [7], [8], [9], [10], [11], [12], [13], [14] (472 patients) and only one trial measured the outcome hospital stay longer than two days (171 patients) [8].

The summary of findings is as follows:

The use of a long-term prophylactic antibiotic regimen compared with a short-term prophylactic antibiotic regimen probably decreases the risk of surgical site infection (moderate certainty of evidence).
The use of a long-term prophylactic antibiotic regimen compared to a short-term prophylactic antibiotic regimen may increase the risk of hospital stay longer than two days (low certainty of evidence).
No studies were found that looked at adverse effects.
No studies were found that looked at mortality.
No studies were found that looked at systemic infection.

Follow the link to access the interactive version of this table (Interactive Summary of Findings – iSoF)

Other considerations for decision-making

To whom this evidence does and does not apply

The results of this summary are applicable to patients who are undergoing orthognathic surgery; and especially to those who present an increased risk of infection, either by concomitant chronic pathologies, drug treatment or by factors inherent to the surgical act, such as magnitude of the osteotomies, exposure to oral fluids and operating time.

About the outcomes included in this summary

All the selected outcomes are considered critical for decision making according to the opinion of the authors of this summary, which coincide in general with those evaluated by the systematic reviews.
The outcome mortality was included in the summary of findings table because it is a relevant outcome for clinical experts, even though it is not a frequent outcome, and was not reported by the reviews either. This also applies to the outcome of adverse effects, which was included because it reports relevant information regarding complications or post-operative aspects associated with orthognathic surgery. However, they were not reported in the reviews.

Balance between benefits and risks, and certainty of the evidence

The evidence included for this summary shows a likely benefit in terms of reducing the risk of surgical site infection using a long-term antibiotic prophylaxis regimen compared to using a short-term one.
On the other hand, the risk of a hospital stay longer than two days using a long-term prophylactic antibiotic regimen is unclear due to the certainty of the evidence. Therefore, we suggest caution when assuming conclusions on this matter.
Based on the above, the risk/benefit balance is favorable towards the use of a long-term prophylactic antibiotic regimen.

Resource considerations

None of the trials conducted a cost analysis regarding the use of antibiotic prophylaxis. However, there is evidence that the additional costs associated with complications of orthognathic surgery can be considerable [1].

What would patients and their doctors think about this intervention

Given the evidence presented in this summary, most patients and surgeons should prefer a long-term prophylactic antibiotic regimen rather than a short-term one, since with the long-term regimen, there is a likely reduction in the risk of infectious postoperative complications and thus in their socio-economic consequences.
Additionally, it is important to emphasize that this is valid as long as there is a correct and precise indication for antibiotic administration.

Differences between this summary and other sources

The conclusions of this summary are consistent with four of the five identified systematic reviews [1], [2], [4], [5], which consider that the long-term prophylactic antibiotic regimen probably reduces the risk of surgical site infection compared to a short-term regimen.
A systematic review [3] reports that the quality of the available evidence is not good enough, and therefore a determination cannot be made with sufficient certainty.
The American Association of Oral and Maxillofacial Surgeons (AAOMS) [15] and British Association of Oral and Maxillofacial Surgeons (BAOMS) [16] clinical guidelines for orthognathic surgery suggest the judicious use of antibiotic prophylaxis to contribute to the reduction of possible postoperative complications, without making any distinction on the type of scheme to be used.

Could this evidence change in the future?

Future research is likely to change the conclusions of this summary, especially in respect to hospital stay longer than two days, because of the uncertainty surrounding this outcome.
We did not identify any ongoing systematic reviews or randomized clinical trials in the National Institute for Health Research's International prospective register of systematic reviews (PROSPERO) and the World Health Organization's International clinical trials registry platform, respectively.

How we conducted this summary

Using automated and collaborative means, we compiled all the relevant evidence for the question of interest and we present it as a matrix of evidence.

Follow the link to access the interactive version: Long-term antibiotic prophylaxis regimen compared to short-term antibiotic prophylaxis regimen in patients undergoing orthognathic surgery.

Notes

The upper portion of the matrix of evidence will display a warning of “new evidence” if new systematic reviews are published after the publication of this summary. Even though the project considers the periodical update of these summaries, users are invited to comment in Medwave or to contact the authors through email if they find new evidence and the summary should be updated earlier.

After creating an account in Epistemonikos, users will be able to save the matrixes and to receive automated notifications any time new evidence potentially relevant for the question appears.

This article is part of the Epistemonikos Evidence Synthesis project. It is elaborated with a pre-established methodology, following rigorous methodological standards and internal peer review process. Each of these articles corresponds to a summary, denominated FRISBEE (Friendly Summary of Body of Evidence using Epistemonikos), whose main objective is to synthesize the body of evidence for a specific question, with a friendly format to clinical professionals. Its main resources are based on the evidence matrix of Epistemonikos and analysis of results using GRADE methodology. Further details of the methods for developing this FRISBEE are described here (http://dx.doi.org/10.5867/medwave.2014.06.5997)

Epistemonikos foundation is a non-for-profit organization aiming to bring information closer to health decision-makers with technology. Its main development is Epistemonikos database (www.epistemonikos.org).

Potential conflicts of interest

The authors do not have relevant interests to declare.

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