Evaluating an evidence-based bundle for preventing surgical site infection: a randomized trial.

OBJECTIVE: To determine if an evidence-based practice bundle would result in a significantly lower rate of surgical site infections (SSIs) when compared with standard practice. DESIGN: Single-institution, randomized controlled trial with blinded assessment of main outcome. The trial opened in April 2007 and was closed in January 2010. SETTING: Veterans Administration teaching hospital. PATIENTS: Patients who required elective transabdominal colorectal surgery were eligible. A total of 241 subjects were approached, 211 subjects were randomly allocated to 1 of 2 interventions, and 197 were included in an intention-to-treat analysis. INTERVENTIONS: Subjects received either a combination of 5 evidenced-based practices (extended arm) or were treated according to our current practice (standard arm). The interventions in the extended arm included (1) omission of mechanical bowel preparation; (2) preoperative and intraoperative warming; (3) supplemental oxygen during and immediately after surgery; (4) intraoperative intravenous fluid restriction; and (5) use of a surgical wound protector. MAIN OUTCOME MEASURE: Overall SSI rate at 30 days assessed by blinded infection control coordinators using standardized definitions. RESULTS: The overall rate of SSI was 45% in the extended arm of the study and 24% in the standard arm (P = .003). Most of the increased number of infections in the extended arm were superficial incisional SSIs (36% extended arm vs 19% standard arm; P = .004). Multivariate analysis suggested that allocation to the extended arm of the trial conferred a 2.49-fold risk (95% confidence interval, 1.36-4.56; P = .003) independent of other factors traditionally associated with SSI. CONCLUSIONS: An evidence-based intervention bundle did not reduce SSIs. The bundling of interventions, even when the constituent interventions have been individually tested, does not have a predictable effect on outcome. Formal testing of bundled approaches should occur prior to implementation.

Prolonged recovery associated with dexmedetomidine when used as a sole sedative agent in office-based oral and maxillofacial surgery procedures.

PURPOSE: Office-based oral and maxillofacial surgical procedures that require sedation are popular. Dexmedetomidine has the advantages of having a minimal effect on respiration and an antisialogogue effect that could make it a good choice for dental procedures. MATERIALS AND METHODS: We performed a prospective pilot study in which patients undergoing office-based oral and maxillofacial surgical procedures received dexmedetomidine as a sole sedative agent. The loading dose of dexmedetomidine (1 microg/kg infused over 10 minutes) was followed by a maintenance dose (0.2 to 0.8 microg/kg/hour) to achieve a Ramsay sedation score of 2 to 3. The demographic data were collected, and the pre- and intraprocedural vital signs and Ramsay sedation score were recorded every 5 minutes. The duration of the procedure, recovery time, and patient and surgeon satisfaction were documented. RESULTS: No statistically significant changes were found in the heart rate, respiratory rate, or oxygen saturation during the procedure when compared to baseline. However, we noticed a significant decrease in the heart rate at the end of the loading dose, and statistically significant change in the blood pressure between baseline and during the procedure (P < .05). The initial local anesthetic injections were recalled by 26% of the patients, and 73% had some recollection of the procedure. Nevertheless, the patient satisfaction score (range 1 to 10) was 8.6 +/- 2.3, and 86% of the patients would recommend this type of sedation. The surgeon satisfaction score (range, 1 to 5) was 3.9 +/- 1.3. The recovery time was prolonged (82.2 +/- 24.3 minutes) when compared with the total procedure time (44.6 +/- 27.9 minutes). CONCLUSIONS: Dexmedetomidine has demonstrated hemodynamic and respiratory stability when used as a sole sedative agent. Despite the discomfort on injection and the lack of reliable amnesic property, patient and surgeon satisfaction were high. However, the prolonged recovery time makes this drug unsuitable for busy office-based practices. We believe it should be reserved for patients with a high risk of respiratory complications (eg, obese patients or those with a history of sleep apnea).