How to Report Data on Bilateral Procedures and Other Issues with Clustered Data: The CLUDA Reporting Guidelines

Hemmingsen, Mathilde N.; Nygaard, Caroline M. T.; Kaufmann, Anna Bartra i; Weltz, Tim K; Larsen, Andreas; Forman, Julie Lyng; Wiberg, Sebastian; Vester-Glowinski, Peter; Ørholt, Mathias; Herly, Mikkel

doi:10.1097/prs.0000000000009293

Cited by 10 publications

(4 citation statements)

References 20 publications

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“…Baseline, intraoperative, and outcomes data were evaluated for significant differences between the 4 randomized study groups. To account for non-independence of patients due to the performance of bilateral procedures, random-effects linear regression was used to determine differences in continuous variables and random-effects logistic regression was used to determine differences in dichotomous variables [5][6][7] .…”

Section: Discussionmentioning

confidence: 99%

Quadriceps Strain and TKA: Contribution of the Tourniquet and Intramedullary Rod to Postoperative Thigh Pain

Stocks

Odoemene

Gex

et al. 2023

Journal of Bone and Joint Surgery

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Background:Thigh pain is relatively common after total knee arthroplasty (TKA) and has been attributed to compression of the thigh muscles by the tourniquet used during surgery. Thigh pain that occurs after a TKA that was performed without a tourniquet may be due to a strain of the quadriceps muscle or insertion of the intramedullary (IM) rod. The purpose of the present study was to determine the cause of thigh pain after TKA in a randomized controlled trial evaluating tourniquet use, IM rod use, and quadriceps strain.Methods:This prospective randomized controlled trial enrolled 97 subjects undergoing primary knee arthroplasty into 4 groups according to tourniquet use (yes or no) and IM rod use (yes or no). Quadriceps strain was evaluated with magnetic resonance imaging (MRI) on postoperative day 1 (POD 1). Data collected preoperatively, intraoperatively, and postoperatively until the 6-week clinical visit included pain levels for the knee and thigh (recorded separately) and knee range of motion.Results:Regardless of tourniquet or IM rod use, 73 (75%) of the 97 patients reported thigh pain on POD 1. Thigh pain at 2 weeks postoperatively was indicative of a quadriceps strain. Use of a tourniquet and patient-reported thigh pain at 2 weeks increased the odds of a quadriceps strain, whereas IM rod use did not significantly contribute to thigh pain.Conclusions:The etiology of thigh pain after TKA may be multifactorial; however, an iatrogenic quadriceps strain is one source of thigh pain after TKA, especially if the pain persists 2 weeks after surgery.Level of Evidence:Prognostic Level I. See Instructions for Authors for a complete description of levels of evidence.

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Section: Discussionmentioning

confidence: 99%

Quadriceps Strain and TKA: Contribution of the Tourniquet and Intramedullary Rod to Postoperative Thigh Pain

Stocks

Odoemene

Gex

et al. 2023

Journal of Bone and Joint Surgery

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“…Binary outcomes were described as simple proportions, and continuous outcomes were described as mean (SD) values or median (IQR) values, depending on the distribution. For each antibiotic, the concentration over time was modeled as a 3-parameter Weibull dose-response function with a fixed lower limit of zero and with a robust covariance matrix estimation to account for multiple measurements per patient . Model selection was performed as a comparison of Weibull, log-logistic, quadratic, and cubic models, and the final model was chosen based on the lowest value of the Akaike information criterion.…”

Section: Methodsmentioning

confidence: 99%

“…For each antibiotic, the concentration over time was modeled as a 3-parameter Weibull dose-response function with a fixed lower limit of zero and with a robust covariance matrix estimation to account for multiple measurements per patient. 29 Model selection was performed as a comparison of Weibull, log-logistic, quadratic, and cubic models, and the final model was chosen based on the lowest value of the Akaike information criterion. The following parameters were calculated for each curve: peak concentration, antibiotic half-life, and time above the MIC.…”

Section: Methodsmentioning

confidence: 99%

Pharmacokinetics of Locally Applied Antibiotic Prophylaxis for Implant-Based Breast Reconstruction

Hemmingsen,

Bennedsen,

Kullab

et al. 2023

JAMA Netw Open

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ImportanceAntibiotic irrigation of breast implants is widely used internationally, but no clinical study has investigated the pharmacokinetics of antibiotic prophylaxis in the breast implant pocket.ObjectivesTo evaluate how long locally applied gentamicin, cefazolin, and vancomycin concentrations in the implant pocket remain above the minimum inhibitory concentration (MIC) for the most common bacterial infections and to measure systemic uptake.Design, Setting, and ParticipantsThis prospective cohort study was performed at the Department of Plastic Surgery and Burns Treatment, Rigshospitalet, Copenhagen, Denmark, between October 25, 2021, and September 22, 2022, among 40 patients undergoing implant-based breast reconstruction who were part of the ongoing BREAST-AB trial (Prophylactic Treatment of Breast Implants With a Solution of Gentamicin, Vancomycin and Cefazolin Antibiotics for Women Undergoing Breast Reconstructive Surgery: a Randomized Controlled Trial). Patients were randomized to receive locally applied gentamicin, cefazolin, and vancomycin or placebo. Samples were obtained from the surgical breast drain and blood up to 10 days postoperatively.ExposuresThe breast implant and the implant pocket were irrigated with 160 μg/mL of gentamicin, 2000 μg/mL of cefazolin, and 2000 μg/mL of vancomycin in a 200-mL saline solution.Main Outcomes and MeasuresThe primary outcome was the duration of antibiotic concentrations above the MIC breakpoint for Staphylococcus aureus according to the Clinical and Laboratory Standards Institute: gentamicin, 4 μg/mL; cefazolin, 2 μg/mL; and vancomycin, 2 μg/mL. Secondary outcomes included the time above the MIC for Pseudomonas aeruginosa and other relevant bacteria, as well as systemic uptake.ResultsThe study included 40 patients (median age, 44.6 years [IQR, 38.3-51.4 years]; median body mass index, 23.9 [IQR, 21.7-25.9]) with a median number of 3 drain samples (range, 1-10 drain samples) and 2 blood samples (range, 0-6 blood samples). Vancomycin and cefazolin remained above the MIC for S aureus significantly longer than gentamicin (gentamicin, 0.9 days [95% CI, 0.5-1.2 days] for blood samples vs 6.9 days [95% CI, 2.9 to 10.9 days] for vancomycin [P = .02] vs 3.7 days [95% CI, 2.2-5.2 days] for cefazolin [P = .002]). The gentamicin level remained above the MIC for P aeruginosa for 1.3 days (95% CI, 1.0-1.5 days). Only cefazolin was detectable in blood samples, albeit in very low concentrations (median concentration, 0.04 μg/mL [range, 0.007-0.1 μg/mL]).Conclusions and RelevanceThis study suggests that patients treated with triple-antibiotic implant irrigation during breast reconstruction receive adequate prophylaxis for S aureus and other common implant-associated, gram-positive bacteria. However, the protection against P aeruginosa may be inadequate.

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“…The correlation between the 2 breasts (that 2 breasts within the same patient are alike) was accounted for with robust covariance matrix estimation. 13 Statistical comparisons of baseline characteristics between the 3 irrigation groups were conducted according to variable type and data distribution. The unadjusted risk of implant infection in the 3 groups was analyzed using a univariable logistic regression.…”

Section: Statistical Analysesmentioning

confidence: 99%

Antibiotic implant irrigation and deep infection: A retrospective study of 1508 patients undergoing breast reconstruction with implants

Hemmingsen

Bennedsen

Kullab

et al. 2023

Plastic &Amp; Reconstructive Surgery

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Background: Antibiotic implant irrigation is increasingly used to prevent deep infection after implant-based breast reconstruction. However, there is limited evidence of the clinical effect. In this study, the authors compare the risk of a deep infection in a Danish population of women who received antibiotic implant irrigation with either gentamicin or vancomycin, or no irrigation. Methods: The authors retrospectively reviewed consecutive patients undergoing all types of breast reconstruction with implants at Rigshospitalet and Herlev Hospital, Denmark, from 2010 to 2019. Logistic regression was used to compare the risk of deep infection between no irrigation and irrigation with gentamicin or vancomycin, and to account for the difference in risk between patient subgroups and risk factors. Results: The authors included 1508 patients who received antibiotic irrigation with gentamicin (500 patients), vancomycin (304 patients), or no irrigation (704 patients). The univariable risk analysis showed a significant decreased risk of deep infection using gentamicin irrigation compared with no irrigation (OR, 0.58; P < 0.05). However, when adjusting for risk factors for infection, there was no significant decrease in the risk of infection when using gentamicin (OR, 0.90; P = 0.71) or vancomycin (OR, 1.0; P = 0.99) compared with the control group. Conclusions: The authors found no significant effect of using antibiotic implant irrigation after isolating it from risk factors for deep infection. However, because of the limitations of the study, the authors cannot conclude that there is no effect of antibiotic implant irrigation. There is a need for a randomized, placebo-controlled trial to investigate the effect, and potential side-effects, of antibiotic implant irrigation.

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How to Report Data on Bilateral Procedures and Other Issues with Clustered Data: The CLUDA Reporting Guidelines

Cited by 10 publications

References 20 publications

Quadriceps Strain and TKA: Contribution of the Tourniquet and Intramedullary Rod to Postoperative Thigh Pain

Quadriceps Strain and TKA: Contribution of the Tourniquet and Intramedullary Rod to Postoperative Thigh Pain

Pharmacokinetics of Locally Applied Antibiotic Prophylaxis for Implant-Based Breast Reconstruction

Antibiotic implant irrigation and deep infection: A retrospective study of 1508 patients undergoing breast reconstruction with implants

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