METHODS: This was an open-label, prospective, multicentre, randomized trial. Three hospitals where the current protocol was to administer prophylactic amoxycillin-clavulanic acid served as the sites of recruitment. Women who delivered vaginally beyond 24+ 0 weeks of gestation with ragged membranes were invited to participate in the trial and randomized into prophylaxis or expectant management with medical advice by blocks of 10, at a 1:1 ratio. A medication adherence diary was provided and patients followed up at 2 weeks and 6 weeks postpartum.
RESULTS: A total of 6569 women gave birth vaginally in three centres during the trial period, of which 10.9% had ragged membranes. The incidence of endometritis was not significantly raised in women with or without prophylaxis (0.90% vs 0.29%; p = 0.60). All cases of endometritis presented within the first 2 weeks and preventive use of antibiotics did not ameliorate the severity of endometritis since rates of ICU admission, surgical evacuation and transfusion were comparable.
CONCLUSION: Preventive use of antibiotics after vaginal delivery in women with ragged placental membranes did not result in a reduction of endometritis. Educating women on the signs and symptoms of endometritis would suffice. Based on the reported incidence of ragged membranes, a change in practice would result in 1500 less prescriptions of antibiotics per annum in these three centres.
TRIAL REGISTRATION: NCT03459599 (Retrospectively registered on 9 March 2018).
OBJECTIVE: The purpose of this report was to describe the longer-term (>12 months) envelope effects on infection reduction and complications.
METHODS: All trial patients who underwent CIED replacement, upgrade, revision, or initial cardiac resynchronization therapy - defibrillator implantation received standard-of-care infection prophylaxis and were randomized in a 1:1 ratio to receive the envelope or not. CIED infection incidence and procedure and system-related complications were characterized through all follow-up (36 months) by using Cox proportional hazards regression modeling.
RESULTS: In total, 6800 patients received their intended randomized treatment (3371 envelope; 3429 control; mean follow-up period 21.0 ± 8.3 months). Major CIED-related infections occurred in 32 envelope patients and 51 control patients (Kaplan-Meier [KM] estimate 1.3% vs 1.9%; hazard ratio [HR] 0.64; 95% confidence interval [CI] 0.41-0.99; P = .046). Any CIED-related infection occurred in 57 envelope patients and 84 control patients (KM estimate 2.1% vs 2.8%; HR 0.69; 95% CI 0.49-0.97; P = .030). System- or procedure-related complications occurred in 235 envelope patients and 252 control patients (KM estimate 8.0% vs 8.2%; HR 0.95; 95% CI 0.79-1.13; P < .001 for noninferiority); the most common were lead dislodgment (1.1%), device lead damage (0.5%), and implant site hematoma (0.4%). Implant site pain occurred less frequently in the envelope group (0.1% vs 0.4%; P = .067). There were no (0.0%) reports of allergic reactions to the components of the envelope (mesh, polymer, or antibiotics).
CONCLUSION: The effects of the TYRX envelope on the reduction of the risk of CIED infection are sustained beyond the first year postprocedure, without an increased risk of complications.
OBJECTIVE: To evaluate the impact of antibiotic stewardship interventions on compliance with surgical antibiotic prophylaxis practice in obstetrics and gynecology surgeries.
METHOD: A prospective pre- and post-intervention study was conducted in two tertiary hospitals between May and December 2016. The duration of the each period was 3 months. Antibiotic stewardship interventions including development of a protocol, educational meeting and audit and feedback were implemented. Data were collected using the patient records and analyzed with SPSS version 23.
RESULTS: A total of 226 and 238 surgical procedures were included in the pre- and post-intervention periods respectively. Age, length of stay and estimated blood loss were similar between the two groups. However, specialty and surgical procedures varied significantly. There was a significant increase in compliance with timing (from 14.2% to 43.3%) and duration (from 0% to 21.8%) of surgical antibiotic prophylaxis after the interventions. The interventions significantly reduced the prescription of third generation cephalosporin (-8.6%), redundant antibiotic (-19.1%), antibiotic utilization (-3.8 DDD/procedure) and cost of antibiotic prophylaxis (-$4.2/procedure). There was no significant difference in the rate of surgical site infection between the two periods. Post-intervention group (OR: 5.60; 95% CI: 3.31-9.47), elective surgery (OR: 4.62; 95% CI: 2.51-8.47) and hospital attended (OR: 9.89; 95% CI: 5.66-17.26) were significant predictors of compliance with timing while elective surgery (OR: 12.49; 95% CI: 2.85-54.71) and compliance with timing (OR: 58.55; 95% CI: 12.66-270.75) were significantly associated with compliance to duration of surgical antibiotic prophylaxis.
CONCLUSION: The interventions improve compliance with surgical antibiotic prophylaxis and reduce antibiotic utilization and cost. However, there is opportunity for further improvement, particularly in non-elective surgical procedures.