ABSTRACT
BACKGROUND: Studies evaluating surgical-site infection have had conflicting results with respect to the use of alcohol solutions containing iodine povacrylex or chlorhexidine gluconate as skin antisepsis before surgery to repair a fractured limb (i.e., an extremity fracture). METHODS: In a cluster-randomized, crossover trial at 25 hospitals in the United States and Canada, we randomly assigned hospitals to use a solution of 0.7% iodine povacrylex in 74% isopropyl alcohol (iodine group) or 2% chlorhexidine gluconate in 70% isopropyl alcohol (chlorhexidine group) as preoperative antisepsis for surgical procedures to repair extremity fractures. Every 2 months, the hospitals alternated interventions. Separate populations of patients with either open or closed fractures were enrolled and included in the analysis. The primary outcome was surgical-site infection, which included superficial incisional infection within 30 days or deep incisional or organ-space infection within 90 days. The secondary outcome was unplanned reoperation for fracture-healing complications. RESULTS: A total of 6785 patients with a closed fracture and 1700 patients with an open fracture were included in the trial. In the closed-fracture population, surgical-site infection occurred in 77 patients (2.4%) in the iodine group and in 108 patients (3.3%) in the chlorhexidine group (odds ratio, 0.74; 95% confidence interval [CI], 0.55 to 1.00; P = 0.049). In the open-fracture population, surgical-site infection occurred in 54 patients (6.5%) in the iodine group and in 60 patients (7.3%) in the chlorhexidine group (odd ratio, 0.86; 95% CI, 0.58 to 1.27; P = 0.45). The frequencies of unplanned reoperation, 1-year outcomes, and serious adverse events were similar in the two groups. CONCLUSIONS: Among patients with closed extremity fractures, skin antisepsis with iodine povacrylex in alcohol resulted in fewer surgical-site infections than antisepsis with chlorhexidine gluconate in alcohol. In patients with open fractures, the results were similar in the two groups. (Funded by the Patient-Centered Outcomes Research Institute and the Canadian Institutes of Health Research; PREPARE ClinicalTrials.gov number, NCT03523962.).
Subject(s)
Anti-Infective Agents, Local , Chlorhexidine , Fracture Fixation , Fractures, Bone , Iodine , Surgical Wound Infection , Humans , 2-Propanol/administration & dosage , 2-Propanol/adverse effects , 2-Propanol/therapeutic use , Anti-Infective Agents, Local/administration & dosage , Anti-Infective Agents, Local/adverse effects , Anti-Infective Agents, Local/therapeutic use , Antisepsis/methods , Canada , Chlorhexidine/administration & dosage , Chlorhexidine/adverse effects , Chlorhexidine/therapeutic use , Ethanol , Extremities/injuries , Extremities/microbiology , Extremities/surgery , Iodine/administration & dosage , Iodine/adverse effects , Iodine/therapeutic use , Preoperative Care/adverse effects , Preoperative Care/methods , Skin/microbiology , Surgical Wound Infection/etiology , Surgical Wound Infection/prevention & control , Fractures, Bone/surgery , Cross-Over Studies , United StatesABSTRACT
BACKGROUND: Preoperative narcotic use has been associated with poor outcomes after total joint arthroplasty (TJA). The purpose of this study is to compare clinical outcomes of patients undergoing elective TJA while concurrently being treated with methadone or buprenorphine/naloxone for prior heroin addiction to a matched control group. METHODS: From an electronic medical record, we collected age, gender, body mass index, the presence of back pain, smoking status, history of alcohol abuse, preoperative use of a pain clinic, and use of antipsychotics, antidepressants, or systemic corticosteroids. Validated outcome measures including the 12-Item Short Form Survey, Knee Society Score (KSS), and Harris Hip Score were used to assess functional outcomes preoperatively and postoperatively. Perioperative data were retrospectively obtained from patient charts. Postoperative functional outcomes were prospectively collected at follow-up visits. Subjects were matched to 2:1 control group on the basis of procedure, sex, diagnosis, age (±5 years), and body mass index (±5 kg/m(2)). Average follow-up was 27.2 months. RESULTS: Significant preoperative differences between the groups included mean morphine-equivalent requirements (997.1 mg for study group vs 24.8 mg for controls), 12-Item Short Form Survey Mental Component Scores (MCS-12; 37.8 for study group vs 49.0 for controls), smoking history, and antipsychotic medication use. Perioperative referral to inpatient Acute Pain Service and mean in-hospital morphine-equivalent narcotic usage (793 mg/24 h for study group vs 109 mg/24 h for controls) also significantly differed between groups. Knee range of motion differed significantly between the cohorts at 1 year (77.5 for study group vs 109.4); however, no significant difference in KSS pain (87.6 vs 84.4), KSS function (61 vs 80.9), Harris Hip Score (89.2 vs 85.3), MCS-12 (47.1 vs 52.9), or complications was observed. CONCLUSION: Equivalent pain control and successful clinical outcome at 1 year can be achieved in patients who use methadone or buprenorphine/naloxone preoperatively.
