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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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Chlorhexidine plus alcohol versus povidone iodine plus alcohol, combined or not with innovative devices, for prevention of short-term peripheral venous catheter infection and failure (CLEAN 3 study): an investigator-initiated, open-label, single centre, randomised-controlled, two-by-two factorial trial.
Guenezan, J, Marjanovic, N, Drugeon, B, Neill, RO, Liuu, E, Roblot, F, Palazzo, P, Bironneau, V, Prevost, F, Paul, J, et al
The Lancet. Infectious diseases. 2021;(7):1038-1048
Abstract
BACKGROUND Two billion peripheral venous catheters are sold globally each year, but the optimal skin disinfection and types of devices are not well established. We aimed to show the superiority of disinfection with 2% chlorhexidine plus alcohol over 5% povidone iodine plus alcohol in preventing infectious complications, and of closed integrated catheters, positive displacement needleless-connectors, disinfecting caps, and single-use prefilled flush syringes used in combination (innovation group) over open catheters and three-way stopcocks for treatment administration (standard group) in preventing catheter failure. METHODS We did an open-label, randomised-controlled trial with a two-by-two factorial design, for which we enrolled adults (age ≥18 years) visiting the emergency department at the Poitiers University Hospital, France, and requiring one peripheral venous catheter before admission to the medical wards. Before catheter insertion, patients were randomly assigned (1:1:1:1) using a secure web-based random-number generator to one of four treatment groups based on skin preparation and type of devices (innovative devices or standard devices; 2% chlorhexidine plus alcohol or 5% povidone iodine plus alcohol). Primary outcomes were the incidence of infectious complications (local infection, catheter colonisation, or bloodstream infections) and time between catheter insertion and catheter failure (occlusion, dislodgment, infiltration, phlebitis, or infection). This study is registered with ClinicalTrials.gov, NCT03757143. FINDINGS 1000 patients were recruited between Jan 7, and Sept 6, 2019, of whom 500 were assigned to the chlorhexidine plus alcohol group and 500 to the povidone iodine plus alcohol group (250 with innovative solutions and 250 with standard devices in each antiseptic group). No significant interaction was found between the two study interventions. Local infections occurred less frequently with chlorhexidine plus alcohol than with povidone iodine plus alcohol (0 [0%] of 496 patients vs six [1%] of 493 patients) and the same was observed for catheter colonisation (4/431 [1%] vs 70/415 [17%] catheters among the catheters cultured; adjusted subdistribution hazard ratio 0·08 [95% CI 0·02-0·18]). Median time between catheter insertion and catheter failure was longer in the innovation group compared with the standard group (50·4 [IQR 29·6-69·4] h vs 30·0 [16·6-52·6] h; p=0·0017). Minor skin reactions occurred in nine (2%) patients in the chlorhexidine plus alcohol group and seven (1%) patients in the povidone iodine plus alcohol group. INTERPRETATION For skin antisepsis, chlorhexidine plus alcohol provides greater protection of peripheral venous catheter-related infectious complications than does povidone iodine plus alcohol. Use of innovative devices extends the catheter complication-free dwell time. FUNDING Becton Dickinson.
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The effect of vaginal disinfection on reducing post-caesarean endometritis: A prospective, randomised controlled trial.
Bağlı, İ, Ege, S, Bademkıran, H, Obut, M, Kahveci, B, Turan, G, Kahramanoğlu, Ö
Journal of gynecology obstetrics and human reproduction. 2021;(3):101981
Abstract
PURPOSE We aimed to evaluate the efficacy of vaginal disinfection using 10 % povidone-iodine on rates of endometritis from post-caesarean infectious diseases before elective caesarean section (CS). METHODS A total of 270 pregnant women who chose to undergo elective CS were recruited for this prospective randomised controlled study. The experimental group comprised 130 patients who had preoperatively undergone vaginal disinfection with 10 % povidone-iodine for 30 s. The control group consisted of 140 patients who had not undergone any vaginal implication before CS. The primary outcome measure was the rate of postpartum endometritis for each group. Intraoperatively, all patients who had closed uterine cervical canals underwent a digital opening of the internal and external cervical canal to equalise the groups. All of the participants were checked for endometritis one week after CS at the hospital. Additionally, for the week before and after surgery, C-reactive protein (CRP) and white blood cell (WBC) values were assessed for both groups. Ethics committee approval number: 339. Statistical analysis was performed using R version 3.5.1 (R statistical Software, Institute for Statistics and Mathematics, Vienna, Austria). RESULTS The groups were balanced in terms of the patients' demographic characteristics. There were no significant differences between the two groups according to endometritis rates: 4.6 % in the study group versus 6.4 % in the control group (p > 0.05). The CRP and WBC values before CS were similar in both groups. In the study group, the CRPand WBC values after CS were lower, whereas they were higher in the control group after CS; these differences were significant (p = 0.01 for CRP and p = 0.001 for WBC). CONCLUSION Vaginal disinfection with povidone-iodine solution 10 % before elective CS does not significantly reduce post-caesarean endometritis rates; however, it does significantly reduce inflammatory markers such as CRP and WBC.
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Efficacy of commercial mouth-rinses on SARS-CoV-2 viral load in saliva: randomized control trial in Singapore.
Seneviratne, CJ, Balan, P, Ko, KKK, Udawatte, NS, Lai, D, Ng, DHL, Venkatachalam, I, Lim, KS, Ling, ML, Oon, L, et al
Infection. 2021;(2):305-311
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PURPOSE One of the key approaches to minimize the risk of COVID-19 transmission would be to reduce the titres of SARS-CoV-2 in the saliva of infected COVID-19 patients. This is particularly important in high-risk procedures like dental treatment. The present randomized control trial evaluated the efficacy of three commercial mouth-rinse viz. povidone-iodine (PI), chlorhexidine gluconate (CHX) and cetylpyridinium chloride (CPC), in reducing the salivary SARS-CoV-2 viral load in COVID-19 patients compared with water. METHODS A total of 36 SARS-CoV-2-positive patients were recruited, of which 16 patients were randomly assigned to four groups-PI group (n = 4), CHX group (n = 6), CPC group (n = 4) and water as control group (n = 2). Saliva samples were collected from all patients at baseline and at 5 min, 3 h and 6 h post-application of mouth-rinses/water. The samples were subjected to SARS-CoV-2 RT-PCR analysis. RESULTS Comparison of salivary Ct values of patients within each group of PI, CHX, CPC and water at 5 min, 3 h and 6 h time points did not show any significant differences. However, when the Ct value fold change of each of the mouth-rinse group patients were compared with the fold change of water group patients at the respective time points, a significant increase was observed in the CPC group patients at 5 min and 6 h and in the PI group patients at 6 h. CONCLUSION The effect of decreasing salivary load with CPC and PI mouth-rinsing was observed to be sustained at 6 h time point. Within the limitation of the current study, as number of the samples analyzed, the use of CPC and PI formulated that commercial mouth-rinses may be useful as a pre-procedural rinse to help reduce the transmission of COVID-19. ISRCTN (ISRCTN95933274), 09/09/20, retrospectively registered.
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A Prospective, Randomized Trial of Povidone-Iodine 0.6% and Dexamethasone 0.1% Ophthalmic Suspension for Acute Bacterial Conjunctivitis.
Ta, CN, Raizman, MB, Gross, RD, Joshi, S, Mallick, S, Wang, Y, Segal, B
American journal of ophthalmology. 2020;:56-65
Abstract
PURPOSE To evaluate the efficacy and safety of a topical ophthalmic suspension combination of povidone-iodine 0.6% (PVP-I) and dexamethasone 0.1% (DEX) for infectious and inflammatory components of bacterial conjunctivitis. DESIGN Randomized, double-masked, multicenter, phase 3 clinical trial. METHODS Subjects of all ages (those <3 months had to be full-term) with a diagnosis of bacterial conjunctivitis were randomized 3:1:3 to either PVP-I/DEX, PVP-I alone, or placebo. The primary endpoint was clinical resolution in the study eye, and the key secondary efficacy endpoint was bacterial eradication, both at the day 5 visit. Adverse events (AEs) were documented at all visits. RESULTS Overall, 753 subjects were randomized (intent-to-treat [ITT] population; PVP-I/DEX [n = 324]; PVP-I [n = 108]; placebo [n = 321]); mean and standard deviation (SD) age was 44.3 (22.9) years, and most were female (61.2%) and white (78.1%). In all treatment groups, mean treatment compliance was >98%. The modified ITT population for the efficacy analysis comprised 526 subjects. In the study eye at the day 5 visit, clinical resolution was achieved by 50.5% (111/220) subjects in the PVP-I/DEX group vs 42.8% (95/222) in the placebo group (P = .127), and bacterial eradication was achieved by 43.3% (94/217) and 46.8% (102/218), respectively (P = .500). Treatment-emergent AEs were experienced by 32.8% (106/323), 39.8% (43/108), and 19.0% (61/321) of subjects in the safety population treated with PVP-I/DEX, PVP-I, and placebo, respectively (most mild in severity). CONCLUSION In this study, PVP-I/DEX did not demonstrate additional benefit in clinical efficacy compared with placebo in subjects with bacterial conjunctivitis.
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Povidone-iodine Irrigation for Pediatric Perforated Appendicitis May Be Protective: A Bayesian Pilot Randomized Controlled Trial.
Anderson, KT, Putnam, LR, Bartz-Kurycki, MA, Hamilton, EC, Yafi, M, Pedroza, C, Austin, MT, Kawaguchi, AL, Kao, LS, Lally, KP, et al
Annals of surgery. 2020;(5):827-833
Abstract
OBJECTIVES A randomized controlled trial was conducted to test the hypothesis that povidone-iodine (PVI) irrigation versus no irrigation (NI) reduces postoperative intra-abdominal abscess (IAA) in children with perforated appendicitis. METHODS A 100 patient pilot randomized controlled trial was conducted. Consecutive patients with acute perforated appendicitis were randomized (1:1) to PVI or NI from April 2016 to March 2017 and followed for 1 year. Patients and postoperative providers were blinded to allocation. The primary endpoint was 30-day image-confirmed IAA. Secondary outcomes included initial and total 30-day length of stay (LOS), emergency department (ED) visits, and readmissions. Intention-to-treat analyses were performed to estimate the probability of clinical benefit using Bayesian regression models (an optimistic prior for the primary outcome and neutral priors for secondary outcomes). Frequentist statistics were also used. RESULTS Baseline characteristics were similar between treatment arms. The PVI arm had 12% postoperative IAA versus 16% in the NI arm (relative risk 0.72, 95% credible interval 0.38-1.23). Bayesian analysis estimates 89% probability that PVI reduces IAA. High probability of benefit was seen in all secondary outcomes for the PVI arm: fewer ED visits and readmissions, and shorter initial and total 30-day LOS. The probability of benefit in reduction of total 30-day LOS in PVI patients was 96% and was significant (P = 0.05) on frequentist analysis. CONCLUSIONS PVI irrigation for perforated appendicitis in children demonstrated a strong probability of reduction in postoperative IAA with a high probability of decreased LOS. With the favorable probability of benefit in all outcomes, this pilot study serves as evidence to continue a definitive trial.
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Safety and Efficacy of Proctosoll Allevia in the Management of Haemorrhoidal Disease in Adults: A Prospective Randomized Clinical Trial.
Sturiale, A, Gallo, G, Brusciano, L, Cacace, C, Cafaro, D, Celedon Porzio, F, Naldini, G
Reviews on recent clinical trials. 2020;(2):152-159
Abstract
INTRODUCTION Hemorrhoidal Disease (HD) is a very common anorectal disorder that affects millions of people around the world and represents a major medical and socioeconomic problem. The aim of the present study was to assess the safety and efficacy of Proctosoll Allevia® in patients affected by symptomatic HD in comparison with the results obtained from a control group. MATERIALS AND METHODS From January to February 2019, all the patients referred to the outpatient clinic of Rajalakshmi Hospital, who were complaining of first or second degree hemorrhoidal symptoms, were enrolled in the study. They were randomly assigned to either of the 2 arms. Group 1: patients were treated with the Proctosoll Allevia® and were under a controlled diet. Group 2: patients were only under a controlled diet without any treatment - control group. RESULTS A total of 51 subjects were screened and 45 (13 F- 32 M) enrolled in the study. All the patients treated with topical application of the cream showed a statistically significant improvement of symptoms within 14 days from the beginning of the therapy if compared to patients who were treated only with a controlled diet. No major adverse events associated with the use of the new product were recorded. CONCLUSION The treatment of I-II degree symptomatic HD with Proctosoll Allevia® has demonstrated to be promising with a good profile of tolerability, safety and efficacy.
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Aqueous olanexidine versus aqueous povidone-iodine for surgical skin antisepsis on the incidence of surgical site infections after clean-contaminated surgery: a multicentre, prospective, blinded-endpoint, randomised controlled trial.
Obara, H, Takeuchi, M, Kawakubo, H, Shinoda, M, Okabayashi, K, Hayashi, K, Sekimoto, Y, Maeda, Y, Kondo, T, Sato, Y, et al
The Lancet. Infectious diseases. 2020;(11):1281-1289
Abstract
BACKGROUND Surgical site infection (SSI) is the most common problem after surgery. Although several guidelines have indicated the efficacy of antiseptics, such as chlorhexidine-alcohol and povidone-iodine, in reducing SSI rate, the optimal recommendation is still not established. Olanexidine might have higher bactericidal activity than other antiseptic agents. However, no randomised study has evaluated the efficacy and safety of olanexidine over conventional antiseptics. We compared the effect of aqueous olanexidine and aqueous povidone-iodine on the incidence of SSI following clean-contaminated surgery. METHODS This was a multicentre, prospective, randomised, blinded-endpoint superiority trial for surgical skin antisepsis in clean-contaminated gastrointestinal and hepatobiliary pancreatic surgeries in four Japanese hospitals. Patients aged 20 years or older who underwent elective clean-contaminated wound surgery were randomly assigned in a 1:1 replacement ratio using a computer-generated block randomisation. Patients were randomly assigned to surgical skin antisepsis with an aqueous formulation of 1·5% olanexidine or surgical skin antisepsis with an aqueous formulation of 10% povidone-iodine before surgery. We used olanexidine in a ready-to-use applicator, and povidone-iodine was administered by a brush or by compression using pliers. Both antiseptics were applied from the papilla with a cranial limit and to the upper thigh with a caudal limit. The antiseptics were allowed to dry for 3 min, and then surgery started. Participants, some investigators, and data analysts were masked to treatment allocation. Participant enrolment was done by non-masked investigators. The primary outcome was 30-day SSI assessed in the intention-to-treat population. The surgical wound site of each participant was observed daily. After discharge, participants underwent at least one outpatient visit within 30 days after surgery. This trial is registered with University hospital Medical Information Network, 000031560. FINDINGS Between June 10, 2018, and April 18, 2019, 883 patients were assessed for eligibility. 587 patients were eligible and 294 received olanexidine and 293 received aqueous povidone-iodine before surgery. 30-day SSI occurred in 19 (7%) patients in the olanexidine group and 39 patients (13%) patients in the povidone-iodine group (adjusted risk difference -0·069; 90% CI -0·109 to -0·029; adjusted risk ratio [RR] 0·48, 90% CI 0·30 to 0·74; p=0·002). Five patients (2%) in the olanexidine group and five (2%) in the povidone-iodine group developed adverse skin reactions (adjusted RR 0·99, 95% CI 0·29 to 3·40; p=1·00). INTERPRETATION Olanexidine significantly reduced the occurrence of overall SSI and superficial incisional SSI compared with aqueous povidone-iodine in clean-contaminated surgery. Our results indicate that olanexidine might have a role to prevent SSI in patients who undergo clean-contaminated surgeries. FUNDING Keio University and Ohyama Health Foundation.
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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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Preoperative skin antisepsis using chlorhexidine may reduce surgical wound infections in lower limb trauma surgery when compared to povidone-iodine - a prospective randomized trial.
Ritter, B, Herlyn, PKE, Mittlmeier, T, Herlyn, A
American journal of infection control. 2020;(2):167-172
Abstract
BACKGROUND For the prevention of surgical wound infections (SSIs), local microorganism counts can be lowered by skin antisepsis prior to surgical incisions. Until now, it has been unclear which antiseptic is the most effective. METHODS This prospective randomized trial analyzed the efficacy of 2 frequently used agents in the reduction of postoperative wound complication rates after aseptic trauma surgery on the lower leg and foot. In the study, 279 consecutive participants were randomized; 112 received surgical skin preparations using chlorhexidine (CHX) (ChloraPrep; Becton Dickinson, Franklin Lakes, NJ) and 167 received preparations with povidone-iodine (PVP-I) (Braunoderm; B. Braun Melsungen AG, Melsungen, Germany). Primary clinical endpoints were SSIs and wound healing disorders (WHDs) within 6 months after surgery. Secondary outcome variables included demographic and perioperative risk factors for SSIs. RESULTS Rates of WHDs and SSIs were significantly higher in the PVP-I treatment group, which experienced 9 SSIs and 12 WHDs (n = 21; 12.6%), compared to the CHX treatment group, which had 2 SSIs and 3 WHDs (n = 5; 4.5%) (P = .022). Perioperative risk factors for WHDs were obesity and longer surgery time, whereas SSIs were increased in participants with cardiovascular diseases and suction drainage. Logistic regression analysis showed that the odds of complications of wound healing were 3.5 times higher for PVP-I than for CHX (odds ratio = 3.5; 95% confidence interval, 1.1-11.2; P = .032). CONCLUSIONS Preoperative skin antisepsis for trauma surgery of the lower leg and foot using CHX led to significantly fewer complications of wound healing when compared to PVP-I.