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      Effectiveness of Single vs Multiple Doses of Prophylactic Intravenous Antibiotics in Implant-Based Breast Reconstruction : A Randomized Clinical Trial

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          Key Points

          Question

          Do rates of postoperative surgical site infections after implant-based breast reconstruction improve when using a multiple-dose instead of a single-dose prophylactic antibiotic regimen?

          Findings

          In this randomized clinical trial, there were no differences in rates of postoperative infections among patients managed with single vs multiple doses of prophylactic antibiotics; multiple doses were associated with higher rates of adverse events.

          Meaning

          Multiple-dose intravenous antibiotic prophylaxis is not superior to a single-dose regimen in preventing postoperative infection after implant-based breast reconstruction and is not recommended because of the associated higher rates of adverse events.

          Abstract

          This randomized clinical trial examines whether multiple-dose antibiotic prophylaxis is superior to single-dose antibiotic prophylaxis in preventing surgical site infection after implant-based breast reconstruction.

          Abstract

          Importance

          Multiple-dose antibiotic prophylaxis is widely used to prevent infection after implant-based breast reconstruction despite the lack of high-level evidence regarding its clinical benefit.

          Objective

          To determine whether multiple-dose antibiotic prophylaxis is superior to single-dose antibiotic prophylaxis in preventing surgical site infection (SSI) after implant-based breast reconstruction.

          Design, Setting, and Participants

          This prospective, multicenter, randomized clinical superiority trial was conducted at 7 hospitals (8 departments) in Sweden from April 25, 2013, to October 31, 2018. Eligible participants were women aged 18 years or older who were planned to undergo immediate or delayed implant-based breast reconstruction. Follow-up time was 12 months. Data analysis was performed from May to October 2021.

          Interventions

          Multiple-dose intravenous antibiotic prophylaxis extending over 24 hours following surgery, compared with single-dose intravenous antibiotic. The first-choice drug was cloxacillin (2 g per dose). Clindamycin was used (600 mg per dose) for patients with penicillin allergy.

          Main Outcomes and Measures

          The primary outcome was SSI leading to surgical removal of the implant within 6 months after surgery. Secondary outcomes were the rate of SSIs necessitating readmission and administration of intravenous antibiotics, and clinically suspected SSIs not necessitating readmission but oral antibiotics.

          Results

          A total of 711 women were assessed for eligibility, and 698 were randomized (345 to single-dose and 353 to multiple-dose antibiotics). The median (range) age was 47 (19-78) years for those in the multiple-dose group and 46 (25-76) years for those in the single-dose group. The median (range) body mass index was 23 (18-38) for the single-dose group and 23 (17-37) for the multiple-dose group. Within 6 months of follow-up, 30 patients (4.3%) had their implant removed because of SSI. Readmission for intravenous antibiotics because of SSI occurred in 47 patients (7.0%), and 190 women (27.7%) received oral antibiotics because of clinically suspected SSI. There was no significant difference between the randomization groups for the primary outcome implant removal (odds ratio [OR], 1.26; 95% CI, 0.69-2.65; P = .53), or for the secondary outcomes readmission for intravenous antibiotics (OR, 1.18; 95% CI, 0.65-2.15; P = .58) and prescription of oral antibiotics (OR, 0.72; 95% CI, 0.51-1.02; P = .07). Adverse events associated with antibiotic treatment were more common in the multiple-dose group than in the single-dose group (16.4% [58 patients] vs 10.7% [37 patients]; OR, 1.64; 95% CI, 1.05-2.55; P = .03).

          Conclusions and Relevance

          The findings of this randomized clinical trial suggest that multiple-dose antibiotic prophylaxis is not superior to a single-dose regimen in preventing SSI and implant removal after implant-based breast reconstruction but comes with a higher risk of adverse events associated with antibiotic treatment.

          Trial Registration

          EudraCT 2012-004878-26

          Related collections

          Most cited references67

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          Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey.

          Although quality assessment is gaining increasing attention, there is still no consensus on how to define and grade postoperative complications. This shortcoming hampers comparison of outcome data among different centers and therapies and over time. A classification of complications published by one of the authors in 1992 was critically re-evaluated and modified to increase its accuracy and its acceptability in the surgical community. Modifications mainly focused on the manner of reporting life-threatening and permanently disabling complications. The new grading system still mostly relies on the therapy used to treat the complication. The classification was tested in a cohort of 6336 patients who underwent elective general surgery at our institution. The reproducibility and personal judgment of the classification were evaluated through an international survey with 2 questionnaires sent to 10 surgical centers worldwide. The new ranking system significantly correlated with complexity of surgery (P < 0.0001) as well as with the length of the hospital stay (P < 0.0001). A total of 144 surgeons from 10 different centers around the world and at different levels of training returned the survey. Ninety percent of the case presentations were correctly graded. The classification was considered to be simple (92% of the respondents), reproducible (91%), logical (92%), useful (90%), and comprehensive (89%). The answers of both questionnaires were not dependent on the origin of the reply and the level of training of the surgeons. The new complication classification appears reliable and may represent a compelling tool for quality assessment in surgery in all parts of the world.
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            Classification of Surgical Complications

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              • Article: not found

              The impact of the gut microbiota on human health: an integrative view.

              The human gut harbors diverse microbes that play a fundamental role in the well-being of their host. The constituents of the microbiota--bacteria, viruses, and eukaryotes--have been shown to interact with one another and with the host immune system in ways that influence the development of disease. We review these interactions and suggest that a holistic approach to studying the microbiota that goes beyond characterization of community composition and encompasses dynamic interactions between all components of the microbiota and host tissue over time will be crucial for building predictive models for diagnosis and treatment of diseases linked to imbalances in our microbiota. Copyright © 2012 Elsevier Inc. All rights reserved.
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                Author and article information

                Journal
                JAMA Netw Open
                JAMA Netw Open
                JAMA Network Open
                American Medical Association
                2574-3805
                16 September 2022
                September 2022
                16 September 2022
                : 5
                : 9
                : e2231583
                Affiliations
                [1 ]Department of Reconstructive Plastic Surgery, Karolinska University Hospital, Stockholm, Sweden
                [2 ]Department of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, Sweden
                [3 ]Department of Surgery, Capio St Göran’s Hospital, Stockholm, Sweden
                [4 ]Department of Breast and Endocrine Surgery, Karolinska University Hospital, Stockholm, Sweden
                [5 ]Department of Infectious Diseases, Karolinska University Hospital, Stockholm, Sweden
                [6 ]Unit of Infectious Diseases, Department of Medicine, Karolinska Institutet, Stockholm, Sweden
                [7 ]Department of Oncology-Pathology, Karolinska Institutet, Stockholm, Sweden
                [8 ]Department of Health Promotion Science, Sophiahemmet University, Stockholm, Sweden
                Author notes
                Article Information
                Accepted for Publication: July 29, 2022.
                Published: September 16, 2022. doi:10.1001/jamanetworkopen.2022.31583
                Open Access: This is an open access article distributed under the terms of the CC-BY License. © 2022 Gahm J et al. JAMA Network Open.
                Corresponding Author: Jessica Gahm, MD, PhD, Department of Reconstructive Plastic Surgery, Karolinska University Hospital, SE 17176 Stockholm, Sweden ( jessica.gahm@ 123456regionstockholm.se ).
                Author Contributions: Dr Frisell had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Drs Gahm and Ljung Konstantinidou contributed equally as co–first authors. Drs de Boniface and Frisell contributed equally as co–last authors.
                Concept and design: Gahm, Lagergren, Sandelin, Glimåker, Wickman, Frisell.
                Acquisition, analysis, or interpretation of data: Gahm, Ljung Konstantinidou, Lagergren, Sandelin, Johansson, de Boniface, Frisell.
                Drafting of the manuscript: Gahm, Glimåker, Johansson, de Boniface, Frisell.
                Critical revision of the manuscript for important intellectual content: Gahm, Ljung Konstantinidou, Lagergren, Sandelin, Wickman, de Boniface, Frisell.
                Statistical analysis: Gahm, Johansson, de Boniface, Frisell.
                Obtained funding: Lagergren, Wickman, Frisell.
                Administrative, technical, or material support: Lagergren, Frisell.
                Supervision: Lagergren, Sandelin, de Boniface, Frisell.
                Conflict of Interest Disclosures: None reported.
                Funding/Support: The trial was initiated by Karolinska University Hospital and Karolinska Institutet. The trial was supported by academic grants from the Swedish state under an agreement between the Swedish government and the county councils, the ALF agreement, project number 20170121, and the Swedish Breast Cancer Association, project number 102946.
                Role of the Funder/Sponsor: The funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
                Data Sharing Statement: See Supplement 3.
                Additional Contributions: We thank all participants in this trial. We also thank the local investigators, clinical staff, and research management at Karolinska University Hospital, Capio St Göran’s Hospital, South General Hospital, Uppsala University Hospital, Umeå University Hospital, Halland Hospital, Halmstad, and Danderyd Hospital. Jonas Bergh (Department of Oncology-Pathology, Karolinska Institutet) contributed to the study as a scientific advisor. Ann Lindén, RN (Department of Medicine, Huddinge, Karolinska Institutet), and Viveca Åberg, RN (Department of Endocrinology and Diabetes, Karolinska Institutet), served as study coordinators. All nonauthor contributors gave written permission to be named in this manuscript, and they were not compensated for their contributions beyond their normal salaries.
                Article
                zoi220890
                10.1001/jamanetworkopen.2022.31583
                9482055
                36112378
                14761816-0448-4fe8-ada4-d529cc5a346e
                Copyright 2022 Gahm J et al. JAMA Network Open.

                This is an open access article distributed under the terms of the CC-BY License.

                History
                : 6 March 2022
                : 29 July 2022
                Categories
                Research
                Original Investigation
                Online Only
                Surgery

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