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Comparison of the antimicrobial efficacy of povidone-iodine-alcohol versus chlorhexidine-alcohol for surgical skin preparation on the aerobic and anaerobic skin flora of the shoulder region.
Dörfel, D, Maiwald, M, Daeschlein, G, Müller, G, Hudek, R, Assadian, O, Kampf, G, Kohlmann, T, Harnoss, JC, Kramer, A
Antimicrobial resistance and infection control. 2021;(1):17
Abstract
BACKGROUND Cutibacterium acnes is part of the anaerobic skin microbiome and resides in deeper skin layers. The organism is an agent of surgical site infections (SSI) in shoulder surgery. We hypothesized that prolonged skin preparation with an agent that penetrates deeply into the skin would be beneficial. Thus, we compared two classes of antiseptics, each combined with alcohol, each applied with two different contact times. METHODS Using a cross-over arrangement, shoulders of 16 healthy volunteers were treated for 2.5 min (standard) or 30 min (prolonged) with alcohol-based chlorhexidine (CHG-ALC) or alcohol-based povidone-iodine (PVP-I-ALC). Skin sites were sampled before, immediately after, and 3 h after treatment, using a standardized cup-scrub technique. RESULTS Aerobic skin flora was reduced more effectively by PVP-I-ALC than by CHG-ALC after 2.5 min application and immediate sampling (reduction factor [RF] 2.55 ± 0.75 vs. 1.94 ± 0.91, p = 0.04), but not after prolonged contact times and 3-h sampling. Coagulase-negative staphylococci were completely eliminated after PVP-I-ALC application, but still recovered from 4 of 32 samples after CHG-ALC application. Anaerobic flora was reduced more effectively by PVP-I-ALC than CHG-ALC after standard (RF 3.96 ± 1.46 vs. 1.74 ± 1.24, p < 0.01) and prolonged (RF 3.14 ± 1.20 vs. 1.38 ± 1.16, p < 0.01) contact times and immediate sampling, but not after 3-h sampling. No adverse events were reported. CONCLUSIONS PVP-I-ALC showed marginal benefits concerning the aerobic flora, but more substantial benefits over CHG-ALC concerning the anaerobic flora of the shoulder. Standard and prolonged contact times showed superiority for PVP-I-ALC for anaerobic flora at all immediate sampling points, but missed significance at 3-h sampling. The results underscore the need for protection against C. acnes and coagulase-negative staphylococci in orthopaedic surgery. The clinical relevance of these findings, however, should be studied with SSI as an endpoint.
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Reduction of Postoperative Wound Infections by Antiseptica (RECIPE)?: A Randomized Controlled Trial.
Strobel, RM, Leonhardt, M, Krochmann, A, Neumann, K, Speichinger, F, Hartmann, L, Lee, LD, Beyer, K, Daum, S, Kreis, ME, et al
Annals of surgery. 2020;(1):55-64
Abstract
OBJECTIVE To evaluate whether intraoperative subcutaneous wound irrigation with 0.04% polyhexanide can reduce surgical site infection (SSI) in elective laparotomies compared to saline. BACKGROUND SSI is a common complication after gastrointestinal surgery. To date, there is a lack of evidence whether subcutaneous wound irrigation is beneficial in terms of reduction of SSI. METHODS The RECIPE trial was an investigator initiated single-center, single-blind prospective, randomized controlled trial with 2 parallel treatment groups, comparing wound irrigation with 0.9% saline to antiseptic 0.04% polyhexanide solution in elective laparotomies. Primary endpoint was the rate of SSI within 30 days postoperatively according to Centers for Disease Control and Prevention criteria. RESULTS Between February 02, 2015, and May 23, 2018, 456 patients were randomly assigned to saline (n = 228) or polyhexanide (n = 228). Final cohort for analysis comprised 393 patients (202 in the saline and 191 in the polyhexanide group). Overall rate of SSI was 28.2%, n = 111. Simple analysis with cross tabulation revealed that significantly fewer SSIs occurred in the polyhexanide group: n = 70 (34.7%) versus n = 41 (21.5%); P = 0.004. In a multiple logistic regression model the factor wound irrigation with polyhexanide [odds ratio (OR) 0.44; 95% confidence interval (CI) 0.27-0.72; P = 0.001) was associated with risk reduction of SSI. Preoperative anemia (OR 2.08; 95% CI 1.27-3.40; P = 0.004) and more than 5 prior abdominal operations compared to none (OR 8.51; 95% CI 2.57-28.21; P < 0.001) were associated with SSI. CONCLUSIONS Intraoperative subcutaneous wound irrigation with antiseptic 0.04% polyhexanide solution is effective in reducing SSI after elective laparotomies.
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The effectiveness of preoperative colon cleansing on post-operative surgical site infection after hip hemiarthroplasty.
Batibay, SG, Soylemez, S, Türkmen, İ, Bayram, Y, Camur, S
European journal of trauma and emergency surgery : official publication of the European Trauma Society. 2020;(5):1071-1076
Abstract
AIM: This study aimed to evaluate the effectiveness of prophylactic mechanical bowel preparation in elderly patients undergoing hip hemiarthroplasty in a single training institution over a period of 2 years. PATIENTS AND METHODS The study was conducted in a prospective-randomised manner. All patients, who underwent primary hip hemiarthroplasty for femoral neck fracture in our institution between 20 February 2015 and 29 December 2016, were included. B.T. Enema (sodium dihydrogen phosphate + disodium hydrogen phosphate) 135 ml (Yenisehir Laboratory, Ankara, Turkey) was used for colon cleansing. RESULTS Ninety-five patients were followed up for at least 1 year after surgery (16.3 ± 4.2 months). Of these, 46 were in the enema group and 49 were in the control group. Demographic and clinical characteristics of patients were similar in both groups (p > 0.05). Infection rates between the two groups were not significantly different (p > 0.05). In addition, ASA, age, sex, presence of diabetes mellitus, duration of surgery, time to surgery, ambulation status and blood count did not have a significant effect on surgical site infections (p > 0.05). However, all infections in the enema group were monobacterial and were successfully treated, whereas two of the four infections in the control group were polymicrobial and could not be successfully treated. CONCLUSION Although preoperative colon cleansing did not reduce the overall incidence of post-operative infections, our study suggested that it may reduce polymicrobial infections after hip hemiarthroplasty. Polymicrobial infections after hip hemiarthroplasty seem to have worse prognosis. Therefore, the effectiveness of preoperative colon cleansing in remediating such infections must be investigated in a larger number of patients.
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Prophylaxis of Wound Infections-antibiotics in Renal Donation (POWAR): A UK Multicentre Double Blind Placebo Controlled Randomised Trial.
Ahmed, Z, Uwechue, R, Chandak, P, van Dellen, D, Barwell, J, Heap, S, Szabo, L, Hemsley, C, Olsburgh, J, Kessaris, N, et al
Annals of surgery. 2020;(1):65-71
Abstract
BACKGROUND Postoperative infection after hand-assisted laparoscopic donor nephrectomy (HALDN) confers significant morbidity to a healthy patient group. Current UK guidelines cite a lack of evidence for routine antibiotic prophylaxis. This trial assessed if a single preoperative antibiotic dose could reduce post HALDN infections. METHODS Eligible donors were randomly and blindly allocated to preoperative single-dose intravenous co-amoxiclav or saline. The primary composite endpoint was clinical evidence of any postoperative infection at 30 days, including surgical site infection (SSI), urinary tract infection (UTI), and lower respiratory tract infection (LRTI). FINDINGS In all, 293 participants underwent HALDN (148 antibiotic arm and 145 placebo arm). Among them, 99% (291/293) completed follow-up. The total infection rate was 40.7% (59/145) in the placebo group and 23% (34 of 148) in the antibiotic group (P = 0.001). Superficial SSIs were 20.7% (30/145 patients) in the placebo group versus 10.1% (15/148 patients) in the antibiotic group (P = 0.012). LRTIs were 9% (13/145) in the placebo group and 3.4% (5/148) in the antibiotic group (P = 0.046). UTIs were 4.1% (6/145) in the placebo group and 3.4% (5/148) in the antibiotic group (P = 0.72).Antibiotic prophylaxis conferred a 17.7% (95% confidence interval 7.2%-28.1%), absolute risk reduction in developing postoperative infection, with 6 donors requiring treatment to prevent 1 infection. INTERPRETATION Single-dose preoperative antibiotic prophylaxis dramatically reduces post-HALDN infection rates, mainly impacting SSIs and LRTIs.
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Subcutaneous rifampicin versus povidone-iodine for the prevention of incisional surgical site infections following gynecologic oncology surgery - a prospective, randomized, controlled trial.
Kömürcü Karuserci, Ö, Balat, Ö
Ginekologia polska. 2020;(9):513-518
Abstract
OBJECTIVES Surgical site infection (SSI) following gynecologic oncology surgery is a severe problem for both patient and surgeon in terms of increasing morbidity, length of hospital stay, anxiety, and costs. In this prospective, randomized, controlled study we investigated the effect of subcutaneous rifampicin and povidone-iodine on incisional SSI following gynecologic oncology surgery. MATERIAL AND METHODS Three hundred patients scheduled for abdominal surgery due to any malign gynecological pathology were randomly assigned into one of three groups of 100 members each, as follows: the subcutaneous tissue was irrigated with saline in Group 1; saline + 10% povidone iodine in Group 2; saline + rifampicin in Group 3. Patients were invited to follow-up once every 10 days in a 30-day period for evaluation. Patients who developed a superficial incisional SSI were recorded. RESULTS No significant relationship was observed between the SSI and the subcutaneous agents used (p = 0.332). It was observed that there was a statistically significant increase in the rate of incisional surgical site infections as the period of hospitalization (p = 0.044), patient's age (p = 0.003), existence of comorbidities (p = 0.001), and perioperative blood transfusion (p = 0.021) increased. CONCLUSIONS Subcutaneous agents are not effective in preventing surgical site infections after gynecologic oncology surgeries. Further large-scale prospective randomized controlled studies may provide other options to prevent SSIs.
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Effectiveness of Iodophor vs Chlorhexidine Solutions for Surgical Site Infections and Unplanned Reoperations for Patients Who Underwent Fracture Repair: The PREP-IT Master Protocol.
, , Slobogean, GP, Sprague, S, Wells, J, Bhandari, M, Rojas, A, Garibaldi, A, Wood, A, Howe, A, Harris, AD, et al
JAMA network open. 2020;(4):e202215
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IMPORTANCE The risk of developing a surgical site infection after extremity fracture repair is nearly 5 times greater than in most elective orthopedic surgical procedures. For all surgical procedures, it is standard practice to prepare the operative site with an antiseptic solution; however, there is limited evidence to guide the choice of solution used for orthopedic fracture repair. OBJECTIVE To compare the effectiveness of iodophor vs chlorhexidine solutions to reduce surgical site infections and unplanned fracture-related reoperations for patients who underwent fracture repair. DESIGN, SETTING, AND PARTICIPANTS The PREP-IT (Program of Randomized Trials to Evaluate Pre-operative Antiseptic Skin Solutions in Orthopaedic Trauma) master protocol will be followed to conduct 2 multicenter pragmatic cluster randomized crossover trials, Aqueous-PREP (Pragmatic Randomized Trial Evaluating Pre-Operative Aqueous Antiseptic Skin Solution in Open Fractures) and PREPARE (Pragmatic Randomized Trial Evaluating Pre-Operative Alcohol Skin Solutions in Fractured Extremities). The Aqueous-PREP trial will compare 4% aqueous chlorhexidine vs 10% povidone-iodine for patients with open extremity fractures. The PREPARE trial will compare 2% chlorhexidine in 70% isopropyl alcohol vs 0.7% iodine povacrylex in 74% isopropyl alcohol for patients with open extremity fractures and patients with closed lower extremity or pelvic fractures. Both trials will share key aspects of study design and trial infrastructure. The studies will follow a pragmatic cluster randomized crossover design with alternating treatment periods of approximately 2 months. The primary outcome will be surgical site infection and the secondary outcome will be unplanned fracture-related reoperations within 12 months. The Aqueous-PREP trial will enroll a minimum of 1540 patients with open extremity fractures from at least 12 hospitals; PREPARE will enroll a minimum of 1540 patients with open extremity fractures and 6280 patients with closed lower extremity and pelvic fractures from at least 18 hospitals. The primary analyses will adhere to the intention-to-treat principle and account for potential between-cluster and between-period variability. The patient-centered design, implementation, and dissemination of results are guided by a multidisciplinary team that includes 3 patients and other relevant stakeholders. DISCUSSION The PREP-IT master protocol increases efficiency through shared trial infrastructure and study design components. Because prophylactic skin antisepsis is used prior to all surgical procedures and the application, cost, and availability of all study solutions are similar, the results of the PREP-IT trials are poised to inform clinical guidelines and bring about an immediate change in clinical practice. TRIAL REGISTRATION ClinicalTrials.gov Identifiers: NCT03385304 and NCT03523962.
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Does an Antimicrobial Incision Drape Prevent Intraoperative Contamination? A Randomized Controlled Trial of 1187 Patients.
Hesselvig, AB, Arpi, M, Madsen, F, Bjarnsholt, T, Odgaard, A, ,
Clinical orthopaedics and related research. 2020;(5):1007-1015
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BACKGROUND The risk of periprosthetic joint infection (PJI), a serious complication after arthroplasty, has not changed for years. Interventions such as eradication of Staphylococcus aureus and antibiotic bone cement are used to diminish infection risk but despite these efforts, the percentage of infection in TKA remains constant. Antimicrobial drapes have a dual action, acting both as a physical and antimicrobial barrier to counter bacterial contamination of the surgical wound. To study the effect of antimicrobial drapes, we used intraoperative contamination as a proxy for infection in our investigation. QUESTIONS/PURPOSES (1) Do antimicrobial surgical drapes reduce the risk of intraoperative microbial contamination in patients undergoing primary knee arthroplasty? (2) Are other factors such as sex, season, age, type of arthroplasty and duration of surgery associated with an increased risk of contamination in patients undergoing primary knee arthroplasty? (3) Does loosening of the antimicrobial drape increase contamination risk? METHODS An investigator-initiated, two-arm, non-blinded, multicenter, randomized, controlled trial was performed at five different hospitals in the capital and central regions of Denmark. Twenty-four surgeons participated in the study. Participants were patients older than 18 years undergoing primary knee arthroplasty. We excluded patients with an iodine allergy, previous open knee surgery, previous septic arthritis, any antibiotics taken 4 weeks before surgery, and if they were unable to understand the implications of study participation. Patients were randomly assigned to operation with an antimicrobial drape (intervention group) or operation without (control group). We screened 1769 patients, of which 100 were ineligible and 10 declined to participate. In all, 94% (1659 of 1769) of patients consented and were randomized to the intervention group (51%, 838 of 1659) and control group (49%, 821 of 1659), respectively. In all, 36% (603 of 1659) of patients in the intervention group and 35% (584 of 1659) patients in the control group were available for final analysis. No crossover was performed, and analysis was done per-protocol. Patients were excluded due to logistic failures like lack of utensils, samples disappearing en route to the laboratory mainly caused by implementation of a new electronic patient chart (EPIC, Verona, WI, USA), and forgetful surgeons. Intraoperatively, we swabbed for bacteria at the surgical site and in a rinse from the surgeons' gloves. All samples were sent for cultivation, and colony forming units (CFUs) counts ≥ 1 were deemed contaminated. The primary outcome measure was the difference in the proportion of contaminated patients between the two randomized groups. Secondary outcome measures were the affiliation of sex, season, age, type of implant used, and duration of surgery on contamination risk. To investigate whether other factors were affiliated with contamination risk, we did a logistic regression to control for confounding variables, including sex, age, season, type of implant and duration of surgery. RESULTS Use of iodinated drapes reduced contamination, with contamination detected in 10% (60 of 603) procedures where iodinated drapes were used compared with 15% (90 of 584) when they were not (odds ratio 0.61 [95% CI 0.43 to 0.87]; p = 0.005), with a relative risk reduction of 35% (95% CI 12.3 to 52.5) and a number needed to treat of 18 patients. After controlling for confounding variables such as sex, age, type of implant, and duration of surgery, we found that not using an antimicrobial drape increased contamination risk by a factor of 1.6 (95% CI 1.08 to 2.35; p = 0.02). Female sex and undergoing surgery in the central region were associated with lower odds of contamination (OR 0.55 [95% CI 0.39 to 0.8]; p = 0.002 and OR 0.45 [95% CI 0.25 to 0.8]; p = 0.006, respectively). Patients with more than a 10-mm separation of the drape from the skin had higher odds of contamination (OR 3.54 [95% CI 1.64 to 11.05]; p = 0.0013). CONCLUSIONS The use of an antimicrobial drape resulted in lower contamination risk than operating without an antimicrobial drape. Our findings suggest that antimicrobial drapes are useful in infection prevention, but further studies are needed to investigate the effect of antimicrobial drapes on infection. LEVEL OF EVIDENCE Level I, therapeutic study.
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Comparison of olanexidine versus povidone-iodine for preventing surgical site infection in gastrointestinal surgery: study protocol for a multicentre, single-blind, randomised controlled clinical trial.
Takeuchi, M, Obara, H, Kawakubo, H, Shinoda, M, Okabayashi, K, Mayanagi, S, Irino, T, Fukuda, K, Nakamura, R, Wada, N, et al
BMJ open. 2019;(5):e028269
Abstract
INTRODUCTION The prevalence of surgical site infection (SSI) remains higher in gastrointestinal surgery than in other surgeries. Although several guidelines have indicated the efficacy of chlorhexidine and povidone-iodine in reducing the SSI rate, the optimal recommendation has still not been established. Therefore, it is necessary to determine the more effective antiseptic for surgical site preparation. Olanexidine (1.5% olanedine, Otsuka Pharmaceutical Factory, Tokushima, Japan), which is a new antiseptic in Japan, has antimicrobial activity against a wide range of bacteria, including Gram-positive and Gram-negative bacteria. Our study will contribute to determining a new antiseptic for use in gastrointestinal and other surgeries. METHODS AND ANALYSIS We propose a multicentre, randomised controlled clinical trial for comparing two treatments, that is, 1.5% olanexidine or 10% povidone-iodine, for surgical skin preparation to prevent SSI in clean-contaminated gastrointestinal surgeries with surgical wounds. Patients aged ≥20 years at the time of consent will be included. The primary outcome measure is the 30-day postoperative SSI rate. For the primary analysis, which is aimed at comparing the treatment effects, the adjusted risk ratio and its 95% CI will be estimated using the Mantel-Haenszel method. ETHICS AND DISSEMINATION The protocol was first approved by the Institutional Review Board of Keio University School of Medicine, followed by the institutional review board of each participating site. Participant recruitment began in June 2018. The final results will be published in international peer-reviewed medical journals. TRIAL REGISTRATION NUMBER UMIN 000031560; Pre-results.
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Steroids in cardiac surgery trial: a substudy of surgical site infections.
McClure, GR, Belley-Cote, EP, Harlock, J, Lamy, A, Stacey, M, Devereaux, PJ, Whitlock, RP
Canadian journal of anaesthesia = Journal canadien d'anesthesie. 2019;(2):182-192
Abstract
PURPOSE Postoperative infection, particularly in cardiac surgery, results in significant morbidity, mortality, and healthcare cost. Identification of novel predictors of postoperative infection can target high-risk populations for prophylactic intervention. METHODS Steroids in cardiac surgery (SIRS) was a multi-centre randomized-controlled trial assessing intraoperative administration of methylprednisone during cardiac surgery, which enrolled 7,507 patients across 80 centres in 18 countries. It demonstrated that administration of steroids had no effect on mortality or major morbidity after cardiac surgery. Our primary objective was to identify risk factors for postoperative surgical site infections using SIRS participants as a cohort. We excluded patients who did not undergo surgery, died intraoperatively, or died within 48 hr of the operation. Patients were assessed for development of "surgical site infection" over the first 30 days postoperatively. Using theoretical and previously identified risk factors, we used forward stepwise entry to create a binary logistic regression model. RESULTS Follow-up at 30 days was complete for all patients; 7,406 were included in the cohort. Surgical site infection occurred in 180 (4.8%) and 184 (5.0%) of patients in the placebo and steroid arms respectively. Significant risk factors (P < 0.05 level) included: diabetes managed with insulin (adjusted odds ratio [aOR]: 1.55; 95% confidence interval [CI] 1.13 to 2.12), oral hypoglycemics (aOR 1.60; 95% CI 1.18 to 2.16), or diet (aOR 1.81; 95% CI 1.16 to 2.83), female sex (aOR 1.34; 95% CI 1.05 to 1.71), renal failure with (aOR 2.03; 95% CI 1.06 to 3.91), and without (aOR 1.50; 95% CI 1.04 to 2.14) dialysis, > 96 min cardiopulmonary bypass (CPB) time (aOR 1.84; 95% CI 1.44 to 2.35), body mass index (BMI) < 22.3 (aOR 0.44; 95% CI 0.28 to 0.71) or > 30 (aOR 1.49; 95% CI 1.17 to 1.89), peak intensive care unit blood glucose (aOR 1.02 per mmol·L-1; 95% CI 1.00 to 1.04), and coronary artery bypass grafting (CABG) operation type (aOR 2.59; 95% CI 1.87 to 3.59). CONCLUSIONS Patients undergoing CABG, requiring longer CPB, with higher BMI, or with diabetes, are at elevated risk of surgical site infection. Strategies to mitigate this risk warrant further investigation.
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Chlorhexidine 0.5%/70% Alcohol and Iodine 1%/70% Alcohol Both Reduce Bacterial Load in Clean Foot Surgery: A Randomized, Controlled Trial.
Shadid, MB, Speth, MJGM, Voorn, GP, Wolterbeek, N
The Journal of foot and ankle surgery : official publication of the American College of Foot and Ankle Surgeons. 2019;(2):278-281
Abstract
No consensus exists regarding which cleansing technique, solution, and concentration should be used in orthopedic surgery. The aim of this randomized, controlled trial was to compare the effect of chlorhexidine 0.5%/70% alcohol with iodine 1%/70% alcohol on lowering positive cultures before elective foot surgery and to study any wound complications, infections and allergic reactions. Consecutive patients ≥18 years of age scheduled for a hallux valgus correction or arthrodesis of the first metatarsophalangeal joint were included. Swabs were taken from 2 sites before and twice after preparing the skin and were quantitatively and qualitatively analyzed. The study group consisted of 49 patients with a mean age of 52.3 ± 14.4 (range 22 to 75) years of whom 42 (86%) were female. No significant differences were observed for positive cultures between the chlorhexidine (73%, 2%, and 12%) and iodine (68%, 7%, and 9%) group at any time point. Coagulase-negative staphylococci were the most commonly isolated micro-organisms found after skin preparation. Occasionally, Bacillus spp and Corynebacterium spp were cultured. The complication rate 2 weeks postoperatively was 0% in the chlorhexidine group versus 8.7% (n = 2) in the iodine group (delayed wound healing; p = .215). The complication rate at 6 weeks postoperatively was, respectively, 3.8% (n = 1) versus 4.3% (n = 1; both showed swelling and redness; p > .999). There was no significant difference in postoperative wound problems or infection rates between the 2 skin preparation solutions. Chlorhexidine 0.5%/70% alcohol and iodine 1%/70% alcohol both decreased the amount of positive cultures in elective foot surgery.