Prevention Of Surgical Site Infections After Major Extremity Trauma

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Prevention of Surgical Site InfectionsAfter Major Extremity TraumaEvidence-Based Clinical Practice GuidelineAdapted by:The American Academy of Orthopaedic Surgeons Board of DirectorsMarch 21, 2022Endorsed by:Please cite this guideline as:American Academy of Orthopaedic Surgeons. Prevention of Surgical Site Infections After Major ExtremityTrauma Evidence-Based Clinical Practice Guideline. www.aaos.org/SSItraumacpg. Published 03/21/22.View background material via the SSI Trauma CPG eAppendix 1View data summaries via the SSI Trauma CPG eAppendix 2

DisclaimerThis clinical practice guideline (CPG) was developed by a physician volunteer clinical practice guidelinedevelopment group based on a formal systematic review of the available scientific and clinicalinformation and accepted approaches to treatment and/or diagnosis. This clinical practice guideline is notintended to be a fixed protocol, as some patients may require more or less treatment or different meansof diagnosis. Clinical patients may not necessarily be the same as those found in a clinical trial. Patientcare and treatment should always be based on a clinician’s independent medical judgment, given theindividual patient’s specific clinical circumstances.Disclosure RequirementIn accordance with AAOS policy, all individuals whose names appear as authors or contributors to theclinical practice guideline filed a disclosure statement as part of the submission process. All panelmembers provided full disclosure of potential conflicts of interest prior to voting on the recommendationscontained within this clinical practice guideline.Funding SourceThis clinical practice guideline was funded exclusively through a research grant provided by the UnitedStates Department of Defense with no funding from outside commercial sources to support thedevelopment of this document.FDA ClearanceSome drugs or medical devices referenced or described in this clinical practice guideline may not havebeen cleared by the Food and Drug Administration (FDA) or may have been cleared for a specific useonly. The FDA has stated that it is the responsibility of the physician to determine the FDA clearancestatus of each drug or device he or she wishes to use in clinical practice.CopyrightAll rights reserved. No part of this clinical practice guideline may be reproduced, stored in a retrievalsystem, or transmitted, in any form, or by any means, electronic, mechanical, photocopying, recording, orotherwise, without prior written permission from METRC. If you wish to request permission, pleasecontact METRC by clicking here or AAOS by clicking here.Published 2019 by the Major Extremity Trauma and Rehabilitation Consortium (METRC) in collaborationwith the American Academy of Orthopaedic Surgeons (AAOS)9400 W HigginsRosemont, ILFirst EditionCopyright 2022 by the Major Extremity Trauma and Rehabilitation Consortium (METRC) and theAmerican Academy of Orthopaedic Surgeons (AAOS)2

To View All AAOS and AAOS-Endorsed Evidence-Based clinical practice guidelines andAppropriate Use Criteria in a User-Friendly Format, Please Visit the OrthoGuidelines WebBased App at www.orthoguidelines.org or by downloading to your smartphone or tablet viathe Apple and Google Play stores!3View background material via the SSI Trauma CPG eAppendix 1View data summaries via the SSI Trauma CPG eAppendix 2

ContentsSUMMARY OF RECOMMENDATIONS . 6Initial Antibiotics . 6Preoperative Antibiotics . 6Surgery Timing . 6Perioperative and Postoperative Antibiotics - Systemic. 6Perioperative and Postoperative Antibiotics – Local . 7Initial Wound Management - Irrigation . 7Initial Wound Management - Fixation . 7Wound Coverage. 8Negative Pressure Wound Therapy – Open and Closed Fractures . 8Open Wound Closure. 8Silver Coated Dressings . 8Modifiable Risk Factors. 9Administrative Risk Factors. 10SUMMARY OF OPTIONS . 11Negative Pressure Wound Therapy - High Risk Surgical Incisions . 11Orthoplastic Team . 11Hyperbaric O2 . 11Preoperative Skin Preparation . 12DEVELOPMENT GROUP ROSTER . 13VOTING MEMBERS. 13NON-VOTING MEMBERS . 13AAOS STAFF . 13INTRODUCTION . 14METHODS . 16LITERATURE SEARCHES . 16DEFINING THE STRENGTH OF RECOMMENDATION . 17INTERPRETING THE STRENGTH OF EVIDENCE . 17Table I. Level of Evidence Descriptions. 18Table II. Interpreting the Strength of a Recommendation or Option . 18REVIEW PERIOD . 18THE AAOS CPG APPROVAL PROCESS . 19REVISION PLANS . 194

CPG DISSEMINATION PLANS . 19STUDY ATTRITION FLOWCHART . 20RECOMMENDATIONS . 21Initial Antibiotics . 21Preoperative Antibiotics . 23Surgery Timing . 25Perioperative and Postoperative Antibiotics – Systemic and Local . 27Initial Wound Management – Irrigation and Fixation. 30Wound Coverage. 33Negative Pressure Wound Therapy – Open and Closed Fractures . 35Open Wound Closure. 37Silver Coated Dressings . 39Modifiable Risk Factors. 41Administrative Risk Factors. 44OPTIONS . 46Negative Pressure Wound Therapy - High Risk Surgical Incisions . 46Orthoplastic Team . 48Hyperbaric O2 . 50Preoperative Skin Preparation . 52APPENDICES. 56Appendix I: References . 56References for Introduction . 56References For Included Literature . 57Appendix II: PICO Questions Used to Define Literature Search . 66Appendix III: PICO Inclusion Criteria . 67Appendix IV: Guideline Development Group Disclosures . 68Voting Members’ and Non-Voting Oversight Chairs’ Disclosures . 685View background material via the SSI Trauma CPG eAppendix 1View data summaries via the SSI Trauma CPG eAppendix 2

SUMMARY OF RECOMMENDATIONSRecommendations are formed when there is sufficient evidence by which to create a directionalstatement. This is defined as evidence from two or more high quality studies (i.e., a strongrecommendation), two or more moderate quality studies (i.e., a moderate recommendation), orstatements resulting in a strong or moderate strength following Evidence to Decision Frameworkupgrading and/or downgrading.Initial AntibioticsEarly delivery of antibiotics is suggested to lower the risk of deep infectionin the setting of open fracture in major extremity trauma.Strength of Evidence: ModerateStrength of Recommendation: ModerateEvidence from two or more “Moderate” quality studies with consistent findings, or evidence from a single “High”quality study for recommending for or against the intervention. Also requires no or only minor concerns addressedin the EtD framework.Preoperative AntibioticsUtilization of preoperative antibiotics is suggested to prevent SSI inoperative treatment of open fractures.Strength of Evidence: LimitedStrength of Recommendation: Moderate(Upgraded)Evidence from one or more “Low” quality studies with consistent findings or evidence from a single “Moderate”quality study recommending for or against the intervention. Also, lower strength evidence can be upgraded tomoderate due to major concerns addressed in the EtD Framework.Surgery TimingIt is suggested that patients with open fractures are brought to the OR fordebridement and irrigation as soon as reasonable, and ideally before 24hours post injury.Strength of Evidence: ModerateStrength of Recommendation: ModerateEvidence from two or more “Moderate” quality studies with consistent findings, or evidence from a single “High”quality study for recommending for or against the intervention. Also requires no or only minor concerns addressedin the EtD framework.Perioperative and Postoperative Antibiotics - SystemicIn patients with major extremity trauma undergoing surgery, it isrecommended that antibiotic prophylaxis with systemic cefazolin or6

clindamycin be administered, except for Type III (and possibly Type II) openfractures, for which additional Gram-negative coverage is preferred.Strength of Evidence: StrongStrength of Recommendation: StrongEvidence from two or more “High” quality studies with consistent findings for recommending for or against theintervention. Also requires no reason to downgrade from the EtD framework.Perioperative and Postoperative Antibiotics – LocalIn patients with major extremity trauma undergoing surgery, local antibioticprophylactic strategies, such as vancomycin powder, tobramycinimpregnated beads, or gentamicin-covered nails, may be beneficial.Strength of Evidence: ModerateStrength of Recommendation: ModerateEvidence from two or more “Moderate” quality studies with consistent findings, or evidence from a single “High”quality study for recommending for or against the intervention. Also requires no or only minor concerns addressedin the EtD framework.Initial Wound Management - IrrigationIrrigation with saline (without additives) is recommended for management ofopen wounds in major extremity trauma.Strength of Evidence: StrongStrength of Recommendation: StrongEvidence from two or more “High” quality studies with consistent findings for recommending for or against theintervention. Also requires no reason to downgrade from the EtD framework.Initial Wound Management - FixationDefinitive fixation of fractures at initial debridement and primary closure ofwounds in selected patients may be considered when appropriate, howeverno favored treatment was observed.Temporizing external fixation remains a viable option for the treatment ofopen fractures in major extremity traumaStrength of Evidence: StrongStrength of Recommendation: Moderate(Downgraded)Evidence from two or more “High” quality studies with consistent findings for recommending for or against theintervention. Also requires no reason to downgrade from the EtD framework.7View background material via the SSI Trauma CPG eAppendix 1View data summaries via the SSI Trauma CPG eAppendix 2

Wound CoverageWound coverage fewer than 7 days from injury date is suggested.Strength of Evidence: ModerateStrength of Recommendation: ModerateEvidence from two or more “Moderate” quality studies with consistent findings, or evidence from a single “High”quality study for recommending for or against the intervention. Also requires no or only minor concerns addressedin the EtD framework.Negative Pressure Wound Therapy – Open and Closed FracturesAfter closed fracture fixation, negative pressure wound therapy may mitigatethe risk of revision surgery or SSIs; however, after open fracture fixation,negative pressure wound therapy does not appear to offer an advantagewhen compared to sealed dressings as it does not decrease woundcomplications or amputations.Strength of Evidence: StrongStrength of Recommendation: StrongEvidence from two or more “High” quality studies with consistent findings for recommending for or against theintervention. Also requires no reason to downgrade from the EtD framework.Open Wound ClosureClosing an open wound when it is feasible, without any gross contaminationis recommended.Strength of Evidence: StrongStrength of Recommendation: StrongEvidence from two or more “High” quality studies with consistent findings for recommending for or against theintervention. Also requires no reason to downgrade from the EtD framework.Silver Coated DressingsSilver coated dressings are not suggested to improve outcomes or decreasepin site infections.Strength of Evidence: ModerateStrength of Recommendation: ModerateEvidence from two or more “Moderate” quality studies with consistent findings, or evidence from a single “High”quality study for recommending for or against the intervention. Also requires no or only minor concerns addressedin the EtD framework.8

Modifiable Risk FactorsIn patients undergoing surgery for major extremity trauma, patients shouldbe counseled that: There may be an increased risk for SSI in patients who smoke or whoare diabetic.Strength of Evidence: StrongStrength of Recommendation: StrongEvidence from two or more “High” quality studies with consistent findings for recommending for or against theintervention. Also requires no reason to downgrade from the EtD framework. There may be an increased risk for SSI in obese patients Significant alcohol use ( 14 units per week) increases the risk ofinfection postoperatively. High flow perioperative FIO2 has not been shown to alter the risk ofpostoperative infection.Strength of Evidence: ModerateStrength of Recommendation: ModerateEvidence from two or more “Moderate” quality studies with consistent findings, or evidence from a single “High”quality study for recommending for or against the intervention. Also requires no or only minor concerns addressedin the EtD framework. Low albumin ( 36g/L) increases the risk of infection postoperatively. Elevated postoperative glucose levels ( 125 mg/dL) increase the riskfor infection. Preoperative transfusion, intraoperative evaluation by a vascularservice in patients with grade 3a, 3b open fractures with well perfusedlimbs, and preoperative MRSA positivity has not been shown to alterthe risk of postoperative infection.Strength of Evidence: LimitedStrength of Recommendation: LimitedEvidence from two or more “Low” quality studies with consistent findings or evidence from a single “Moderate”quality study recommending for or against the intervention. Also, higher strength evidence can be downgraded tolimited due to major concerns addressed in the EtD Framework.9View background material via the SSI Trauma CPG eAppendix 1View data summaries via the SSI Trauma CPG eAppendix 2

Administrative Risk FactorsIn patients undergoing surgery for major extremity trauma, patients shouldbe counseled that: There is minimal evidence that race, or socioeconomic status affectsrisk of SSI.Strength of Evidence: ModerateStrength of Recommendation: ModerateEvidence from two or more “Moderate” quality studies with consistent findings, or evidence from a single “High”quality study for recommending for or against the intervention. Also requires no or only minor concerns addressedin the EtD framework. There is no significant difference in risk of SSI when being treated asan inpatient or outpatient.Strength of Evidence: LimitedStrength of Recommendation: LimitedEvidence from two or more “Low” quality studies with consistent findings or evidence from a single “Moderate”quality study recommending for or against the intervention. Also, higher strength evidence can be downgraded tolimited due to major concerns addressed in the EtD Framework.10

SUMMARY OF OPTIONSOptions are formed when there is little or no evidence on a topic. This is defined as low quality evidenceor a single moderate quality study (i.e., a limited strength option), no evidence or only conflictingevidence (i.e., a consensus option), or statements resulting in a limited or consensus strength followingEvidence to Decision Framework upgrading and/or downgrading.Negative Pressure Wound Therapy - High Risk Surgical IncisionsIt is suggested to use an incisional negative pressure wound therapy forhigh- risk surgical incisions (e.g., pilon, plateau, or calcaneus fractures) toreduce the risk of deep surgical site infection.Strength of Evidence: LimitedStrength of Recommendation: LimitedEvidence from two or more “Low” quality studies with consistent findings or evidence from a single “Moderate”quality study recommending for or against the intervention. Also, higher strength evidence can be downgraded tolimited due to major concerns addressed in the EtD Framework.Orthoplastic TeamImplementation of an orthoplastic team may decrease length of stay, deepinfection, and additional operations to bone, and also may help improve timeto wound healing and time to union.Strength of Evidence: LimitedStrength of Recommendation: LimitedEvidence from two or more “Low” quality studies with consistent findings or evidence from a single “Moderate”quality study recommending for or against the intervention. Also, higher strength evidence can be downgraded tolimited due to major concerns addressed in the EtD Framework.Hyperbaric O2In patients with open fracture, hyperbaric O2 may not benefit patientoutcomes.Strength of Evidence: LimitedStrength of Recommendation: LimitedEvidence from two or more “Low” quality studies with consistent findings or evidence from a single “Moderate”quality study recommending for or against the intervention. Also, higher strength evidence can be downgraded tolimited due to major concerns addressed in the EtD Framework.11View background material via the SSI Trauma CPG eAppendix 1View data summaries via the SSI Trauma CPG eAppendix 2

Preoperative Skin PreparationIn the absence of reliable evidence, it is the opinion of the workgroup that:1. Providers may consider perioperative nasal and skin (full body)decolonization of patients, when possible.2. Patients should shower or bathe (full body) with soap (anti-microbial ornon-anti-microbial) or an antiseptic agent before surgery, when possible.3. Surgical skin preparation should be performed with an alcohol-basedantiseptic agent, unless contraindicated.Strength of Evidence: ConsensusStrength of Option: ConsensusThere is no supporting evidence, or limited level evidence was downgraded due to major concerns addressed inthe EtD framework. In the absence of reliable evidence, the guideline work group is making a recommendationbased on their clinical opinion.12

DEVELOPMENT GROUP ROSTERVOTING MEMBERSAshton Goldman, MDCo-Chair, Society of Military OrthopaedicSurgeonsKevin Tetsworth, MDCo-Chair, American Academy of OrthopaedicSurgeonsAidin Eslam Pour, MD, FAAOSAmerican Association of Hip and KneeSurgeonsEric Ricchetti, MD, FAAOSAmerican Shoulder and Elbow SurgeonsRyan Harrison, MD, FAAOSOrthopaedic Trauma AssociationRobin Patel, MDInfectious Diseases Society of AmericaChristopher Gross, MD, FAAOSAmerican Orthopaedic Foot & Ankle SocietyGregory Della Rocca, MD, PhD, FAAOSAmerican Academy of Orthopaedic SurgeonsUktu Kandemir, MD, FAAOSAmerican Academy of Orthopaedic SurgeonsWilliam Obremsky, MD, MPH, FAAOSMajor Extremity Trauma Research ConsortiumManjari Joshi, MBBSMajor Extremity Trauma Research ConsortiumRobert O’Toole, MDMajor Extremity Trauma Research ConsortiumRenan Castillo, MDMajor Extremity Trauma Research ConsortiumKali Tileston, MD, FAAOSPeriatric Orthopaedic Society of North AmericaNON-VOTING MEMBERSAntonia Chen, MD, MBA, FAAOSOversight Chair, American Academy of Orthopaedic SurgeonsAAOS/ METRC STAFFEllen MacKenzie, PhDDean of Bloomberg School of Public HealthJayson Murray, MADirectorClinical Quality and Value, AAOSKaitlyn Sevarino, MBA, CAEDirectorClinical Quality and Value, AAOSDanielle Schulte, MSManagerClinical Quality and Value, AAOSConnor Riley, MPHResearch Data SpecialistClinical Quality and Value, AAOSTyler VerityMedical Research LibrarianClinical Quality and Value, AAOSJennifer RodriguezQuality Development AssistantClinical Quality and Value, AAOS13View background material via the SSI Trauma CPG eAppendix 1View data summaries via the SSI Trauma CPG eAppendix 2

INTRODUCTIONOVERVIEWThis Clinical Practice Guideline (CPG) is oneof six funded by a Department of Defensegrant to the METRC collaborative to evaluatethe evidence regarding various aspects ofrecovery from injury to determine the mosthelpful recommendations for treatment. TheCPG herein is based on a systematic reviewof published studies examining the preventionof surgical site infection (SSI) after majorextremity trauma in adults. It providesrecommendations that will help practitioners tointegrate the current evidence and clinicalpractice, and it highlights gaps in the literaturein need of future research. This guideline isintended to be used by appropriately trainedphysicians and clinicians who manage thetreatment of major extremity trauma. It alsoserves as an information resource fordevelopers and applied users of clinicalpractice guidelines.GOALS AND RATIONALEThe purpose of this clinical practice guidelineis to evaluate the current best evidenceassociated with treatment. Evidence-basedmedicine (EBM) standards advocate for use ofempirical evidence by physicians in theirclinical decision making. To assist with accessto the large resources of information, asystematic review of the literature inpublication was conducted betweenNovember 2020 and August 2021. It highlightswhere there is good evidence, whereevidence is lacking, and what topics futureresearch will need to target in order to helpfacilitate evidence-based decision making inthe prevention of SSI in patients with majorextremity trauma. AAOS staff methodologistsassisted the physician/clinician work group inevaluating the existing literature so that theycould formulate the followingrecommendations based on a rigoroussystematic process. Musculoskeletal care isprovided in many different settings and by avariety of providers. We created this guidelineas an educational tool to guide qualifiedphysicians and clinicians in making treatmentdecisions that improve the quality and efficacyof care. This guideline should not beconstrued as including all possible methods ofcare or excluding acceptable interventionssimilarly directed at obtaining favorableoutcomes. The final decision to use a specificprocedure must be made after assessing allconcerns presented by the patient andconsideration of locality-specific resources.INTENDED USERSThis guideline is intended to be used byorthopaedic surgeons and other healthcareproviders managing adults with majorextremity trauma. It serves as an informationresource for medical practitioners. In general,individual practicing physicians and cliniciansdo not have the resources required tocomplete a project of comparable scope andduration involving the evaluation of anextensive literature base. In April 2019, theAAOS adopted the use of the GRADEEvidence-to-Decision Framework into itsclinical practice guideline developmentmethodology. This Framework enables workgroup members to incorporate additionalfactors into the strength of eachrecommendation and move away from therigidity of previous AAOS recommendationlanguage stems. The AAOS intends for thisguideline to assist treatment providers notonly in making shared clinical decisions withtheir patients, but also in describing to patientsand their loved ones why a selectedintervention represents the best availablecourse of treatment. This guideline is notintended for use as a benefits determinationdocument. It does not cover allocation ofresources, business and ethicalconsiderations, and other factors needed todetermine the material value of orthopaediccare. Users of this guideline may also want toconsider the appropriate use criteria (AUC)related to the prevention of SSI in majorextremity trauma.PATIENT POPULATIONThis guideline is intended for use with adults( 18yrs) who have sustained a majorextremity trauma. Major extremity trauma wasdefined by the working group.The population included all injury types limitedto the context of an extremity fracture:14

1.2.3.4.5.6.7.8.Open fractureMajor/High energy closed fractureDegloving injuryMorel lesionsGunshot injury (low and high velocity)Crush injuryBlast injuryModerate to high energy forceSCOPEThe scope of this guideline includespreoperative, perioperative, and postoperativeinterventions in addition to an evaluation ofrisk factors to decrease

This clinical practice guideline (CPG) was developed by a physician volunteer clinical practice guideline development group based on a formal systematic review of the available scientific and clinical information and accepted approaches to treatment and/or diagnosis. This clinical practice guideline is not

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