Effect of antiseptic cord care on bacterial colonization in the newborn infant. Topical application of chlorhexidine to neonatal umbilical cords for prevention of omphalitis and neonatal mortality in a rural district of Pakistan: a community-based, cluster-randomised trial. Topical applications of chlorhexidine to the umbilical cord for prevention of omphalitis and neonatal mortality in southern Nepal: a community-based, cluster-randomised trial. A randomized controlled trial of point-of-care evidence to improve the antibiotic prescribing practices for otitis media in children. The effect of cord cleansing with chlorhexidine on neonatal mortality in rural Bangladesh: a community-based, cluster-randomised trial. Communication training and antibiotic use in acute respiratory tract infections. A cluster randomised controlled trial in general practice. Staphylococcal and streptococcal colonization of the newborn infant: effect of antiseptic cord care. A community intervention trial to promote judicious antibiotic use and reduce penicillin-resistant Streptococcus pneumoniae carriage in children. Higher rate of cord-related adverse events in neonates with dry umbilical cord care compared to chlorhexidine powder. Results of a randomized controlled study to compare efficacy and safety of chlorhexidine powder versus dry care in umbilical cord care of the newborn. Midwifery: umbilical cord care in pre-term babies. Prophylactic antibacterial therapy for preventing urinary tract infections in spinal cord injury patients. Cleaning solutions and bacterial colonization in promoting healing and early separation of the umbilical cord in healthy newborns. Umbilical cord care: the effect of eight different cord-care regimens on cord separation time and other outcomes. Educational strategies to promote evidence-based community pharmacy practice: a cluster randomized controlled trial (RCT). Use of antibiotic prophylaxis in ear surgery. Pilot study for appropriate anti-infective community therapy. Effect of a guideline-based strategy to optimize use of antibiotics. Single-dose v. short-term antibiotic therapy for prevention of wound infection in general surgery. A prospective, randomized double-blind trial.
A randomized controlled study was undertaken to compare the effectiveness of three umbilical cord treatment regimens in controlling neonatal bacterial colonization. The regimens studied included daily application of castile soap, triple dye and silver sulfadiazine. The triple dye and silver sulfadiazine regimens inhibited bacterial colonization. Staphylococcal colonization was inhibited most effectively by triple dye treatment. Group B streptococcal colonization was equally inhibited by triple dye and silver sulfadiazine. Silver sulfadiazine was more effective in controlling colonization with gram-negative microorganisms. Umbilical cord infection (omphalitis) is a risk factor for neonatal sepsis and mortality in low-resource settings where home deliveries are common. We aimed to assess the effect of umbilical-cord cleansing with 4% chlorhexidine (CHX) solution, with or without handwashing with antiseptic soap, on the incidence of omphalitis and neonatal mortality.
                We did a two-by-two factorial, cluster-randomised trial in Dadu, a rural area of Sindh province, Pakistan. Clusters were defined as the population covered by a functional traditional birth attendant (TBA), and were randomly allocated to one of four groups (groups A to D) with a computer-generated random number sequence. Implementation and data collection teams were masked to allocation. Liveborn infants delivered by participating TBAs who received birth kits were eligible for enrolment in the study. One intervention comprised birth kits containing 4% CHX solution for application to the cord at birth by TBAs and once daily by family members for up to 14 days along with soap and educational messages promoting handwashing. One intervention was CHX solution only and another was handwashing only. Standard dry cord care was promoted in the control group. The primary outcomes were incidence of neonatal omphalitis and neonatal mortality. The trial is registered with ClinicalTrials.gov, number NCT00682006.
                187 clusters were randomly allocated to one of the four study groups. Of 9741 newborn babies delivered by participating TBAs, factorial analysis indicated a reduction in risk of omphalitis with CHX application (risk ratio [RR]=0·58, 95% CI 0·41-0·82; p=0·002) but no evidence of an effect of handwashing (RR=0·83, 0·61-1·13; p=0·24). We recorded strong evidence of a reduction in neonatal mortality in neonates who received CHX cleansing (RR=0·62, 95 % CI 0·45-0·85; p=0·003) but no evidence of an effect of handwashing promotion on neonatal mortality (RR=1·08, 0·79-1·48; p=0·62). We recorded no serious adverse events.
                Application of 4% CHX to the umbilical cord was effective in reducing the risk of omphalitis and neonatal mortality in rural Pakistan. Provision of CHX in birth kits might be a useful strategy for the prevention of neonatal mortality in high-mortality settings.
                The United States Agency for International Development.
                Copyright Â© 2012 Elsevier Ltd. All rights reserved. Omphalitis contributes to neonatal morbidity and mortality in developing countries. Umbilical cord cleansing with antiseptics might reduce infection and mortality risk, but has not been rigorously investigated.
                In our community-based, cluster-randomised trial, 413 communities in Sarlahi, Nepal, were randomly assigned to one of three cord-care regimens. 4934 infants were assigned to 4.0% chlorhexidine, 5107 to cleansing with soap and water, and 5082 to dry cord care. In intervention clusters, the newborn cord was cleansed in the home on days 1-4, 6, 8, and 10. In all clusters, the cord was examined for signs of infection (pus, redness, or swelling) on these visits and in follow-up visits on days 12, 14, 21, and 28. Incidence of omphalitis was defined under three sign-based algorithms, with increasing severity. Infant vital status was recorded for 28 completed days. The primary outcomes were incidence of neonatal omphalitis and neonatal mortality. Analysis was by intention-to-treat. This trial is registered with , number NCT00109616.
                Frequency of omphalitis by all three definitions was reduced significantly in the chlorhexidine group. Severe omphalitis in chlorhexidine clusters was reduced by 75% (incidence rate ratio 0.25, 95% CI 0.12-0.53; 13 infections/4839 neonatal periods) compared with dry cord-care clusters (52/4930). Neonatal mortality was 24% lower in the chlorhexidine group (relative risk 0.76 [95% CI 0.55-1.04]) than in the dry cord care group. In infants enrolled within the first 24 h, mortality was significantly reduced by 34% in the chlorhexidine group (0.66 [0.46-0.95]). Soap and water did not reduce infection or mortality risk.
                Recommendations for dry cord care should be reconsidered on the basis of these findings that early antisepsis with chlorhexidine of the umbilical cord reduces local cord infections and overall neonatal mortality. Prescribing practices for otitis media are not consistent with current evidence-based recommendations.
                To determine whether point-of-care evidence delivery regarding the use and duration of antibiotics for otitis media decreases the duration of therapy from 10 days and decreases the frequency of prescriptions written.
                Randomized, controlled trial.
                Primary care pediatric clinic affiliated with university training program. Intervention. A point-of-care evidence-based message system presenting real time evidence to providers based on their prescribing practice for otitis media.
                Proportion of prescriptions for otitis media that were for <10 days and frequency with which antibiotics were prescribed.
                Intervention providers had a 34% greater reduction in the proportion of time they prescribed antibiotics for <10 days. Intervention providers were less likely to prescribe antibiotics than were control providers.
                A point-of-care information system integrated into outpatient pediatric care can significantly influence provider behavior for a common condition. Up to half of neonatal deaths in high mortality settings are due to infections, many of which can originate through the freshly cut umbilical cord stump. We aimed to assess the effectiveness of two cord-cleansing regimens with the promotion of dry cord care in the prevention of neonatal mortality.
                We did a community-based, parallel cluster-randomised trial in Sylhet, Bangladesh. We divided the study area into 133 clusters, which were randomly assigned to one of the two chlorhexidine cleansing regimens (single cleansing as soon as possible after birth; daily cleansing for 7 days after birth) or promotion of dry cord care. Randomisation was done by use of a computer-generated sequence, stratified by cluster-specific participation in a previous trial. All livebirths were eligible; those visited within 7 days by a local female village health worker trained to deliver the cord care intervention were enrolled. We did not mask study workers and participants to the study interventions. Our primary outcome was neonatal mortality (within 28 days of birth) per 1000 livebirths, which we analysed on an intention-to-treat basis. This trial is registered with ClinicalTrials.gov, number NCT00434408.
                Between June, 2007, and September, 2009, we enrolled 29 760 newborn babies (10 329, 9423, and 10 008 in the multiple-cleansing, single-cleansing, and dry cord care groups, respectively). Neonatal mortality was lower in the single-cleansing group (22·5 per 1000 livebirths) than it was in the dry cord care group (28·3 per 1000 livebirths; relative risk [RR] 0·80 [95% CI] 0·65-0·98). Neonatal mortality in the multiple-cleansing group (26·6 per 1000 livebirths) was not statistically significantly lower than it was in the dry cord care group (RR 0·94 [0·78-1·14]). Compared with the dry cord care group, we recorded a statistically significant reduction in the occurrence of severe cord infection (redness with pus) in the multiple-cleansing group (risk per 1000 livebirths=4·2 vs risk per 1000 livebirths=1·2; RR 0·35 [0·15-0·81]) but not in the single-cleansing group (risk per 1000 livebirths=3·3; RR 0·77 [0·40-1·48]).
                Chlorhexidine cleansing of a neonate's umbilical cord can save lives, but further studies are needed to establish the best frequency with which to deliver the intervention.
                United States Agency for International Development and Save the Children's Saving Newborn Lives program, through a grant from the Bill & Melinda Gates Foundation.
                Copyright Â© 2012 Elsevier Ltd. All rights reserved. A cluster-randomised controlled trial in general practice
                Physician-patient communication plays a key role in treatment decisions in primary care. We aimed to reduce the antibiotic prescription rate for acute respiratory tract infections using a short training programme in patient-centred communication.
                We conducted a cluster-randomised controlled trial in 45 general practices in Switzerland. Thirty physicians received evidence-based guidelines for the management of acute respiratory tract infections; 15 physicians randomised to the full intervention additionally received training in patient-centred communication. A further 15 physicians, not randomised, served as a control to blind the physicians in the other two groups to the true comparison. The primary outcome was the antibiotic prescription rate reported by pharmacists. Secondary outcomes were patient satisfaction and enablement, re-consultation rates, days with restrictions, and days off work. 1108 adults with acute respiratory infections were screened between January and May 2004. Outcomes were measured in 837 consultations; 624 patients had follow-up interviews at 7 and 14 days.
                The antibiotic prescription rate reported by pharmacists was low in both full and limited intervention groups (13.5% and 15.7% respectively) but only half of the antibiotics were prescribed according to guidelines (53.8% and 53.1%). No significant differences were seen between the two randomised groups in primary and secondary outcomes. In both groups patient satisfaction was high (median score for both 68 out of 70).
                In this trial, patient-centred communication training did not reduce the rate of antibiotic prescriptions below an already unusually low level. Even with this low prescription rate, patient satisfaction with received care was high. A randomized controlled study was undertaken to compare the effectiveness of three umbilical cord treatment regimens in controlling neonatal bacterial colonization. The three regimens studied included castile soap, triple dye, and silver sulfadiazine. The triple dye and silver sulfadiazine application inhibited bacterial colonization. Staphylococcal colonization was inhibited by both treatment regimens but most effectively by triple dye. Group B streptococcal colonization was inhibited most effectively by silver sulfadiazine while triple dye application to the umbilicus promoted colonization with this microorganism. Silver sulfadiazine was more effective in controlling colonization with Gram-negative microorganisms. Inappropriate use of antibiotics is common in primary care, and effective interventions are needed to promote judicious antibiotic use and reduce antibiotic resistance. The objective of this study was to assess the impact of parent and clinician education on pediatric antibiotic prescribing and carriage of penicillin-nonsusceptible Streptococcus pneumoniae in child care facilities.
                A nonrandomized, controlled, community intervention trial was conducted in northern Wisconsin Clinicians. Clinic staff received educational materials and small-group presentations; materials were distributed to parents through clinics, child care facilities, and community organizations. Prescribing data were analyzed for 151 clinicians who provided primary pediatric care; nasopharyngeal carriage of penicillin-nonsusceptible S pneumoniae was assessed for 664 children in the baseline period (January-June 1997) and for 472 children in the postintervention period (January-June 1998).
                The median number of solid antibiotic prescriptions per clinician declined 19% in the intervention region and 8% in the control region. The median number of liquid antibiotic prescriptions per clinician declined 11% in the intervention region, compared with an increase of 12% in the control region. Retail antibiotic sales declined in the intervention region but not in the control region. Among participating children in child care facilities, there were no significant differences in antibiotic use or penicillin-nonsusceptible S pneumoniae colonization between the intervention and control regions.
                A multifaceted educational program for clinicians and parents led to community-wide reductions in antibiotic prescribing, but in child care facilities, there was no apparent impact on judicious antibiotic use or colonization with drug-resistant S pneumoniae. Longer follow-up time or greater reductions in antibiotic use may be required to identify changes in the pneumococcal susceptibility. Best practice for umbilical cord care (UC) still remains controversial in developed countries with aseptic perinatal care. A bicenter randomized clinical trial was performed to evaluate the efficacy of chlorhexidine (CX) powder versus dry cord care (DC) for UC.
                All neonates of two neonatal care units were invited to take part in the study. Participants were randomized to either DC or UC with CX powder (0.1%). Primary study outcome was the cord separation time. Secondary outcomes were omphalitis, granuloma of the umbilical ground, adverse events and parents' treatment satisfaction. The outcome parameters were documented at a hospital-located study visit 10-14 days after birth.
                669 neonates were enrolled in the trial. 337 were randomized to receive CX powder for umbilical cord care, 332 to DC. Cord separation time was 7.0 +/- 2.5 days in CX-treated neonates and 7.8 +/- 2.9 days in DC (p < 0.001). There were 9 cases of omphalitis, 2 in the CX group, 7 in the DC group (p = 0.1). No difference in the occurrence of umbilical granuloma between the treatment regimens was detected. Neonates randomized to CX were less likely to have an adverse event (140 in 109 subjects vs. 205 in 149 subjects in the DC neonates; p = 0.001). Half of these adverse events were cord-related. Neonates randomized to DC had nearly twice as many cord-related adverse events as those with CX treatment (CX: 58 in 54 patients vs. DC: 110 in 97 patients; p < 0.001). Parents' treatment satisfaction was significantly higher in the neonates with CX cord care.
                Cord-related adverse events in neonatal umbilical cord care remain a clinical issue. Even in an aseptic birth context in a developed country, cord care with CX powder showed a reduction of cord-related adverse events.
                Copyright 2009 S. Karger AG, Basel. A trial was undertaken to investigate infection rates and to measure cord separation time under four different cord care regimes in pre-term babies within the Neonatal Unit of Ninewells Hospital, Dundee. The evidence of the trial suggests that the present method of treating umbilical cords in pre-term babies with Sterets and Ster-zac powder is sound. More importantly, there is good evidence that a policy of leaving umbilical cords untreated cannot be recommended as safe practice within the unit. It is noted that the numbers in this trial (about 100) were not large, but the trial did run for a full year. Any further trials would need to be multicentered to obtain a larger sample set in a reasonable amount of time. We conducted 202 trials in 161 male hospital patients to determine if prophylactic administration of ascorbic acid or antibacterials (trimethoprim-sulfamethoxazole, nalidixic acid, methenamine hippurate or nitrofurantoin macrocrystals) would prevent bacteriuria infections in spinal cord injury patients who had had at least 1 bout of bacteriuria. None of the drugs tested appeared to be statistically effective in the doses used in preventing bacteriuria in these patients. Moreover, sensitivities were lost to several drugs other than those used prophylactically. We conclude that use of prophylactic doses of ascorbic acid or antibacterials has not proved to be beneficial in spinal cord injury patients free of indwelling catheters. The efficacy of alcohol or water in promoting umbilical cord separation was compared in a randomized controlled trial. Rates of skin colonization between groups were also evaluated on three occasions. Time to cord separation, rates of colonization, and species of organisms that colonized were compared between groups. Of 148 participants, 136 (92%) completed the protocol. Cords that were cleaned with sterile water separated more quickly than those cleaned with alcohol (t = 3.15, p = 0.002). Between-group differences in colonization rates were not found (F = 1.59, df = 2, p = 0.205). Umbilical or other infections did not occur. Bacterial colonization of the umbilical area and surrounding skin occurs over time in healthy term neonates. Cleaning with alcohol will increase the length of time from birth to cord separation but will not prevent colonization of the umbilical area. In this study we evaluate the effect of eight cord-care regimens on cord separation time and other secondary outcomes: omphalitis, sepsis, death, cord bleeding, compliance, satisfaction or dissatisfaction with regard to the type of treatment, umbilical cord colonization--in 1,535 healthy term infants. The eight cord-care regimens studied were: 70% alcohol, natural drying, salicylic sugar powder, triple dye, micronized green clay powder, colloid silver-benzyl-peroxide powder, neomycin-bacitracin powder, 1% basic fuchsine. None of the newborns developed sepsis or died and we found only sporadic cases of omphalitis. With regard to cord separation time the best results were obtained with salicylic sugar powder (5.6 +/- 2.3 days) and green clay powder (6.7 +/- 2.2 days). Both forms of treatment proved to be more effective (p < 0.05) than all the others. We found that salicylic sugar powder allows for early cord detachment resulting in excellent parent treatment compliance and reduction of their concern, notwithstanding higher percentages of cord bleeding. The rate of positive umbilical swabs was low and was significantly higher only than the results obtained with neomycin-bacitracin powder treatment. This study demonstrates that, in hospital nurseries of developed countries, salicylic sugar powder can be effectively and safely used for umbilical cord care of healthy term infants.
                Copyright 2002 S. Karger AG, Basel Community pharmacists have increasing involvement in the self-management of minor illness as a result of the availability of a wider range of over-the-counter (OTC) medicines. We undertook a randomized controlled trial (RCT) to assess the effectiveness and efficiency of educational strategies to implement evidence-based guidelines for the sale of OTC anti-fungals in the community pharmacy setting.
                The aim of the study was to compare the effectiveness and efficiency of two guideline dissemination strategies in community pharmacy settings.
                A 2 x 2 factorial, cluster RCT was conducted with 60 community pharmacies in the Grampian region of Scotland. The interventions included dissemination of an evidence-based guideline for OTC management of vulvovaginal candidiasis (thrush) by postal dissemination (control), educational outreach visit or attendance at a continuing professional education session. Pre- and post-intervention simulated patient visits were made to participating pharmacies. The simulated patients completed assessment forms following each visit. The primary outcome was the appropriateness (based upon the guidelines) of sale or no sale of OTC anti-fungals.
                There were no significant differences in the proportion of appropriate outcomes following educational outreach [odds ratio (OR) = 1.1; 95% confidence interval (CI) 0.52 to 2.45] or continuing professional education (OR = 0.88; 95% CI 0.41 to 1.91).
                Neither strategy was effective in improving the appropriateness of OTC management of vulvovaginal candidiasis by community pharmacy staff. Further research is needed to identify barriers to guideline implementation and evidence-based practice in this setting. A prospective, double-blind, randomized, placebo-controlled study was performed to evaluate the effect of antibiotic prophylaxis in ear surgery. The present study reports on the results of 750 patients, half of whom received cefuroxime for 1 day, the other half, placebo. All postoperative infections occurring within 2 weeks after the intervention were recorded, together with several preoperative and perioperative parameters. It is concluded that exploratory tympanoplasties (including stapedotomy) and "dry perforation" tympanoplasties should be considered "clean" operations according to the American National Research Council and do not benefit from antibiotic prophylaxis. On the other hand, tympanoplasties performed on draining ears and on ears with cholesteatoma should be considered "dirty" operations for which antibiotic prophylaxis may decrease the postoperative infection rate by factor 3. All postoperative infections healed without sequels under proper treatment, except for three that resulted in graft necrosis--one in the placebo group and two in the cefuroxime group. In consequence, prophylaxis may not be mandatory in the dirty group, although the authors advocate its use for the sake of patient and surgeon comfort. To determine whether a community-wide, multi-intervention educational strategy (CoMPLI model) could enhance adoption of clinical guidelines and improve the use of antibiotics.
                Before-after trial using baseline and study periods with a control group.
                A small community in central Ontario.
                Health professionals, the general public, and the pharmaceutical industry.
                The educational strategy (CoMPLI), carried out during 6 winter months, consisted of continuing medical education sessions for health professionals and pharmaceutical representatives and a parallel public education campaign that included town hall meetings and pamphlets distributed by local pharmacists. The two main messages were: do not use antibiotics for viral respiratory infections, and use drugs recommended in the publication, Anti-infective Guidelines for Community-Acquired Infections.
                Total number of antibiotic claims and adjusted odds ratios (OR) were used to measure the likelihood of physicians prescribing first- or second-line agents compared with the previous year and compared with control physicians.
                Claims in the study community decreased by nearly 10% during the 6-month study period compared with the baseline period from the previous year. Study physicians were 29% less likely (OR-1 = 0.71, range 0.67 to 0.76) to prescribe second-line antibiotics during the study period than physicians in the rest of the province.
                Physicians participating in the pilot study were more likely to follow drug recommendations outlined in published guidelines. To investigate the effectiveness of a single-dose antibiotic regimen for preventing postoperative wound infection, a prospective, randomized double-blind trial was carried out in patients undergoing "clean-contaminated", "contaminated" or "clean" (vascular) surgery. Both elective and emergency operations were included. Single-dose (preoperative) prophylaxis was compared with short-term prophylaxis (1 dose preoperatively and 2 doses postoperatively). The antibiotics were penicillin, tobramycin and metronidazole in various combinations, and comparisons between single-dose and short-term prophylaxis were made with all the regimens. The incidence of wound infection was 5/277 (1.8%) in the short-term group and 9/287 (3.1%) in the single-dose group. The difference was not statistically significant. Nor was statistically significant difference found when the type of operation and the degree of contamination were considered. Single-dose antibiotic prophylaxis thus gave a low incidence of postoperative wound infection, even in "clean-contaminated" or "contaminated" cases.
Good trials in low-income settings are warranted. In high-income settings, there is limited research which has not shown an advantage of antibiotics or antiseptics over simply keeping the cord clean. Quality of evidence is low.