Surgical site antiseptic preparations for otolaryngology - Head and neck surgery: A current review.

OBJECTIVE: To review current literature and guidelines on antiseptic surgical site preparations for preventing surgical site infections with consideration of contraindications specific to head and neck surgery. DATA SOURCES: PubMed/MEDLINE, clinicaltrials.gov, accessdata.fda.gov, Manufacturer websites. REVIEW METHODS: A scoping review on the literature and clinical studies comparing the efficacy of different surgical site preparations. Studies were included if they were a randomized controlled trial (RCT) comparing at least two commonly used and available antiseptic preparations. Additionally, a compilation of warnings and contraindications from manufacturer labels and articles are included. Due to the lack of randomized controlled trials concerning antiseptic preparation use in head and neck surgery specifically, an additional search was executed for articles not limited to randomized controlled trials that compared different antiseptic preparation used in surgeries concerning the head and neck. RESULTS: Of 56,983 resulting abstracts and 3798 of them being screened, 25 RCTs were included. These RCTs included a variety of surgeries including gastrointestinal, obstetric, gynecologic, orthopedic, and vascular procedures. When searching for abstracts concerning head and neck surgeries, 9 studies were found and included. CONCLUSIONS: To reduce surgical site infections and avoid application in situations with contraindications, practicing surgeons need to be familiar with the existing literature regarding different surgical preparations and what warnings manufacturers have listed on the products. Optimal surgical site preparation for head and neck surgery is challenging as proximity to oxygen contraindicates newer alcohol-based options that are potentially flammable. We summarize evidence-based surgical site preparation for head and neck surgery.

Association of Medicaid Privatization With Patient Cancer Outcomes.

PURPOSE: Increasingly, states outsource administration of Medicaid insurance to privately administered Medicaid managed care organizations. However, on January 1, 2012, Connecticut transitioned from a privately to publicly administered Medicaid system. New Jersey retained a private model. METHODS: Our objective was to assess rates of early-stage cancer diagnosis and cancer survival in two states with similar sociodemographic characteristics but differing exposures to Medicaid privatization. Using data from the SEER Program between 2007 and 2016, Connecticut and New Jersey Medicaid patients with 10 common solid cancers including breast, lung, colorectal, prostate, kidney, bladder, cervix, uterus, head and neck cancer, and melanoma were included. A difference-in-differences analysis of stage of cancer presentation and cancer survival in Connecticut (intervention) was compared with New Jersey (control). RESULTS: Among 29,328 patients (14,424 patients from Connecticut and 14,904 patients from New Jersey) parallel trends were verified in early cancer diagnosis and survival for both states under privately administered Medicaid (pre-exposure). Connecticut's transition from privately to publicly administered Medicaid was associated with an adjusted 4.0% increase in overall early-stage cancer diagnosis (95% CI, +1.7% to +6.2%) and a 4.7% increase in early-stage cancer diagnosis for cancers with US Preventive Services Taskforce A/B recommendations for cancer screening (95% CI, 1.6% to 7.8%). Public administration of Medicaid was also associated with improved overall survival after cancer diagnosis (hazard ratio, 0.92 [95% CI, 0.85 to 0.99]). No changes were observed in New Jersey. CONCLUSION: Transition from private to public administration of Medicaid in Connecticut was associated with earlier-stage cancer diagnosis and improved cancer survival.

Surgical Fires Involving Alcohol-Based Preparation Solution, 1991-2020.

BACKGROUND: Alcohol-based skin preparations were first approved for surgical use in 1998 and have since become standard in most surgical fields. The purpose of this report is to examine incidence of surgical fires because of alcohol-based skin preparation and to understand how approval and regulation of alcohol-based skin preparations impacted trends in fires over time. METHODS: We identified all reported surgical fires resulting in patient or staff harm from 1991 through 2020 reported to the Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database. We examined incidence of fires because of these preparations, trends after approval and regulation, and common causes. RESULTS: We identified 674 reports of surgical fires resulting in harm to patients and surgical personnel, in which 84 involved an alcohol-based preparation. The time-adjusted model shows that from 1996 through 2006, there was a 26.4% increase in fires followed by a 9.7% decrease from 2007 to 2020. The decrease in fires was most rapid for head and neck and upper aerodigestive tract surgeries. Qualitative content analysis revealed improper surgical site preparation as well as close proximity of surgical sites to an oxygen source as the most common causes of fires. CONCLUSION: Since FDA approval, alcohol-based preparation solutions have been associated with a significant percentage of surgical fires. Warning label updates from 2006 to 2012 coupled with increased awareness efforts of associated risks of alcohol-based surgical solutions likely contributed to the decrease in fires. Improper surgical site preparation technique and close proximity of surgical sites to oxygen continue to be risk factors for fires. LEVEL OF EVIDENCE: 4 Laryngoscope, 134:607-613, 2024.

Multiorganizational consensus to define guiding principles for perioperative pain management in patients with chronic pain, preoperative opioid tolerance, or substance use disorder.

Significant knowledge gaps exist in the perioperative pain management of patients with a history of chronic pain, substance use disorder, and/or opioid tolerance as highlighted in the US Health and Human Services Pain Management Best Practices Inter-Agency Task Force 2019 report. The report emphasized the challenges of caring for these populations and the need for multidisciplinary care and a comprehensive approach. Such care requires stakeholder alignment across multiple specialties and care settings. With the intention of codifying this alignment into a reliable and efficient processes, a consortium of 15 professional healthcare societies was convened in a year-long modified Delphi consensus process and summit. This process produced seven guiding principles for the perioperative care of patients with chronic pain, substance use disorder, and/or preoperative opioid tolerance. These principles provide a framework and direction for future improvement in the optimization and care of 'complex' patients as they undergo surgical procedures.

Updated Centers for Disease Control and Prevention Guidelines on Opioid Prescribing: What Should Surgeons Know?

The Centers for Disease Control and Prevention (CDC) recently published a 2022 guideline on opioid prescribing for acute, subacute, and chronic pain. This information is relevant to surgeons because many patients receive their first opioid prescription after surgery. When prescribing opioids, surgeons walk the line between benefit and harm. Many of the CDC recommendations mirror the AAO-HNS Clinical Practice Guideline: Opioid Prescribing for Analgesia After Common Otolaryngology Operations. For example, opioids are not recommended as first-line therapy for acute pain from otolaryngology-head, and neck surgery procedures. New insights include safeguards and strategies to mitigate the risk of complications in patients with chronic pain undergoing surgical procedures. Consultation with a pain specialist should be considered for patients transitioning from acute to chronic pain, cognizant of the risks of abrupt discontinuation of opioids in patients with opioid use disorder. This article summarizes key considerations for providing individualized, evidence-based perioperative pain management.

Association of Surgical Margin Distance With Survival in Patients With Resected Head and Neck Squamous Cell Carcinoma: A Secondary Analysis of a Randomized Clinical Trial.

Importance: Clear surgical margins reduce the risk of local recurrence, improve survival, and determine decision-making with regard to adjuvant treatment of squamous cell carcinoma of the head and neck (SCCHN). However, the definitions of clear, close, or positive surgical margins vary in both the literature and in practice. Objective: To examine whether the association between surgical margin distance and survival varies by primary tumor site. Design, Setting, and Participants: This was a secondary analysis of a multi-institutional, multinational randomized clinical trial. The trial enrolled patients from January 22, 2007, to March 29, 2013, with stage II to IVA resected SCCHN with extranodal extension (ENE) or positive margins (<5 mm from invasive tumor to the resected margin). The current analysis included those patients with known ENE and margin status and was conducted from April 29, 2022, to December 19, 2022. Interventions: Patients received adjuvant chemoradiotherapy plus either placebo or lapatinib. Main Outcomes and Measures: Overall survival (OS) was calculated to examine association with surgical margin distance, primary site, and survival, with stratification by ENE status. Results: Among 688 patients enrolled in the trial, 630 patients with known ENE and margin status were included. Exact patient ages were not made available; 523 (83%) patients were male, and 415 (66%) patients were White. Patients with 1 high-risk feature (positive margins or ENE) had significantly better OS vs 2 high-risk features (hazard ratio [HR], 0.65; 95% CI, 0.49-0.87), although most other results were not statistically significant. For example, in the cohort with ENE-negative disease, multivariable adjusted analysis showed nonsignificant improvements with shorter surgical margin distance (1- to 5-mm margins), and no association with OS was found in the cohort with ENE-positive status (either >5 mm margins or 1-5 mm margins). The association between survival and margin distance varied based on primary site, human papillomavirus (HPV) status, and ENE status. For example, HPV-positive status was associated with a significant and clinically meaningful increase in survival (adjusted HR, 0.33; 95% CI, 0.11-0.97). The improvement was greatest, although not significantly so, in patients with ENE- and HPV-negative oropharynx (OP), hypopharynx (HP), and larynx cancer (HR, 0.57; 95% CI, 0.30-1.10). No survival benefit was seen in ENE-negative oral cavity cancer (HR, 0.89; 95% CI, 0.45-1.77), nor was an association observed between margins and OS in HPV-positive OP cancer. Conclusions and Relevance: In this secondary analysis of a randomized clinical trial, the presence of high-risk features (extranodal extension, positive margins, or both) was associated with worse survival; longer survival was observed with greater surgical margin distance among patients with oral cavity tumors and human papillomavirus-negative tumors of the OP, larynx, or HP. No other significant differences were found. These findings support variable interpretation of surgical margin distance based on the primary site and HPV status. Trial Registration: ClinicalTrials.gov Identifier: NCT00424255.

Surgical Fire in the United States: 2000-2020.

BACKGROUND: Despite fire prevention protocols and perioperative staff training, surgical fires continue to cause patient harm, disability, and death. METHODS: We identified surgical fires that were reported to the Food and Drug Administration's Manufacturer and User Facility Device Experience database between 2000 and 2020 that resulted in patient or surgical personnel harm. Quantitative and descriptive content analyses were performed on free-text responses to identify contributing factors of surgical fire patient and personnel harm events. RESULTS: We identified 565 surgical fire events resulting in patient or surgical personnel harm over a 20-year study period (median 25 events/year; range, 8-53). Surgical fires were significantly more likely to occur during upper aerodigestive tract (unadjusted odds ratio 15.96; 95% confidence interval, 11.93-21.34) and head and neck (unadjusted odds ratio 5.47; confidence interval 4.14-7.22) procedures compared with abdomen and pelvis procedures. Upper aerodigestive tract and head and neck procedures had the highest incidence of life-threatening injury (41% and 21%, respectively). An electrosurgical device was the ignition source in 82% of events. Content analysis revealed 7 common categories identified as root causes of surgical fires: preparation of surgical site (n = 55, 29%); device malfunction (n = 51, 26%), surgical accident (n = 47, 24%), medical judgement (n = 44 reports, 23%), equipment care and handling (n = 18, 9%), patient factors (n = 10, 5%), and communication (n = 3, 2%). CONCLUSION: Surgical fires resulting in harm to patient and surgical personnel continue to occur. The common themes identified in this study will prepare and empower surgeons and surgical personnel to prevent surgical fires in the future.

Surgical salvage of human papillomavirus-positive oropharyngeal cancer: Secondary analysis of a randomized controlled trial.

BACKGROUND: Survival outcomes are generally better for human papillomavirus-associated oropharyngeal squamous cell carcinoma (HPV+ OPSCC) than other forms of head and neck cancer. However, less is known about oncologic outcomes, late adverse events, and gastrostomy tube dependence associated with salvage surgery after the failure of definitive chemoradiation in patients with HPV+ OPSCC. METHODS: A secondary analysis of the Radiation Therapy Oncology Group 1016 randomized trial, which compared radiotherapy plus cetuximab to radiotherapy plus cisplatin in patients with HPV+ OPSCC, was performed. The oncologic and adverse event outcomes for patients who underwent salvage surgery were examined. RESULTS: Among the 805 patients who were assigned to treatment and were eligible for analysis, 198 developed treatment failure. Salvage surgery was required for 61 patients (7.6%), with 33 patients undergoing salvage surgery after locoregional failure (LRF) and 28 patients undergoing salvage neck dissection within the 20 weeks after treatment. Patients with LRF who underwent salvage surgery experienced improved overall survival in comparison with patients with LRF who did not undergo surgery (45% vs. 17% at 5 years after treatment; hazard ratio, 0.41; 95% confidence interval [CI], 0.23-0.74). Surgical salvage after LRF was associated with similar frequencies of late grade 3/4 dysphagia in comparison with LRF without surgery (24% [95% CI, 13%-41%] vs. 20% [95% CI, 12%-32%]; p = .64) and with similar gastrostomy tube dependence at 2 years (29% [95% CI, 15%-49%] vs. 13% [95% CI, 5%-28%]; p = .12). CONCLUSIONS: Salvage surgery in patients with HPV+ OPSCC is associated with favorable survival and adverse event outcomes.

African American race as a risk factor associated with a second primary lung cancer after initial primary head and neck cancer.

BACKGROUND: Initial primary head and neck cancer (IPHNC) is associated with second primary lung cancer (SPLC). We studied this association in a population with a high proportion of African American (AA) patients. METHODS: Patients with IPHNC and SPLC treated between 2000 and 2017 were reviewed for demographic, disease, and treatment-related characteristics and compared to age-and-stage-matched controls without SPLC. Logistic and Cox regression models were used to analyze the relationship of these characteristics with the development of SPLC and overall survival (OS). RESULTS: Eighty-seven patients and controls were compared respectively. AA race was associated with a significantly higher risk of developing SPLC (OR 2.92, 95% CI 1.35-6.66). After correcting for immortal time bias, patients with SPLC had a significantly lower OS when compared with controls (HR 0.248, 95% CI 0.170-0.362). CONCLUSIONS: We show that AA race is associated with an increased risk of SPLC after IPHNC; reasons of this increased risk warrant further investigation.

Mortality from Aspiration Pneumonia: Incidence, Trends, and Risk Factors.

Aspiration pneumonia is a potentially preventable, aggressive type of pneumonia. Little is understood on the burden in mortality from aspiration pneumonia. Our objectives were to first examine the burden of mortality from aspiration pneumonia in the United States and second investigate comorbidities associated with aspiration pneumonia to understand risk factors. We conducted a case-control study of individuals who died of aspiration pneumonia matched to those who died of other causes. We analyzed all deaths in the United States using the Multiple Cause of Death Dataset from 1999 to 2017. Cases were matched with controls based on age, sex, and race. We calculated age-adjusted mortality rates, annual percentage changes in aspiration pneumonia mortality, and matched odds ratio comparisons. We identified a total of 1,112,944 deaths related to aspiration pneumonia from 1999 to 2017 or an average of 58,576 per year (age-adjusted mortality rate, 21.85 per 100,000 population; 95% confidence interval (CI) 21.78-21.92). Aspiration pneumonia was reported as the underlying cause of death in 334,712 deaths or an average of 17,616 deaths per year (30.1% of the total aspiration pneumonia-associated deaths). Individuals 75 years old or older accounted for 76.0% of aspiration pneumonia deaths and the age adjusted rate ratio was 161.0 (CI 160.5-161.5). Neurologic, upper gastrointestinal, and pulmonary conditions as well as conditions associated with sedative substances were more often associated with aspiration pneumonia-associated deaths. Aspiration pneumonia is the underlying cause or a cofactor in tens of thousands of deaths each year in the United States. Aspiration pneumonia-associated deaths are highly prevalent with advanced age and are associated with neurologic, upper gastrointestinal and pulmonary conditions.

Association of State-Imposed Restrictions on Gabapentin with Changes in Prescribing in Medicare.

BACKGROUND: Between August 2016 and July 2018, three states classified gabapentin as a Schedule V drug and nine states implemented prescription drug monitoring program (PDMP) regulation for gabapentin. It is highly unusual for states to take drug regulation into their own hands. The impact of these changes on gabapentin prescribing is unclear. OBJECTIVE: To determine the effect of state-imposed regulation on gabapentin prescribing for Medicare Part D enrollees from 2013 to 2018. DESIGN: Population-based difference-in-difference(DID) analysis study utilizing the Medicare Part D Prescriber Public Use File. PARTICIPANTS: All eligible Medicare Part D prescribers excluding those outside of the fifty states and the District of Columbia were included in our analysis. Prescriber data and key sociodemographic variables were organized by state and year. States with a gabapentin schedule change or PDMP regulation enacted before 2019 were included in the intervention group. For the Schedule V DID analysis, a control group of the ten highest opioid-prescribing states was used. INTERVENTIONS: States with gabapentin schedule changes or PDMP regulation before January 1, 2019, were included and compared to control states that did not implement these policies. MAIN MEASURES: Total days' supply of gabapentin per enrollee per year was the primary outcome variable. KEY RESULTS: The mean total days' supply of gabapentin per enrollee increased 41% from 19.71 to 27.81 total days' supply per enrollee per year between 2013 and 2018. After adjustment, Schedule V gabapentin regulation resulted in a reduction of 8.37 total days of gabapentin prescribed per enrollee (95% confidence interval of - 10.34 to - 6.39). In contrast, PDMP regulation resulted in a reduction of 1.01 total days of gabapentin prescribed per enrollee (95% confidence interval of - 1.74 to - 0.29). CONCLUSIONS: Classifying gabapentin as a Schedule V drug results in substantial reduction in total days prescribed whereas PDMP regulation results in modest reduction.

Incidence of Head and Neck Cancer With Lung Cancer Screening: Secondary Analysis of a Randomized Controlled Trial.

OBJECTIVES/HYPOTHESIS: To evaluate the incidence of head and neck cancers (HNC) in high-risk current and/or former smokers with screening low-dose computed tomography (LDCT) chest versus chest x-ray (CXR). STUDY DESIGN: Second analysis of randomized clinical trial. METHODS: We performed a secondary analysis examining the incidence of HNC in the National Lung Screening Trial. This was a randomized trial comparing LDCT versus CXR screening for lung cancer detection in high-risk individuals (30 pack-year smokers who currently smoke or quit within the last 15 years, aged 55-74). We compared the incidence of HNC in participants screened with LDCT versus CXR. We performed subgroup analyses in participants with mucosal HNC (oral cavity, oropharynx, larynx, hypopharynx, nasal/sinus cavity, or nasopharynx) or nonmucosal HNC (thyroid or salivary gland) and examined survival in the two screening arms. RESULTS: This trial enrolled 53,452 participants with a median follow-up of 6.2 years after randomization. The incidence of HNC was 111.8 cases per 100,000 person-years in the LDCT group versus 87.1 cases per 100,000 person-years in the CXR group (rate ratio 1.30, 95% confidence interval [CI] 1.05-1.61). There were 11.7 deaths from HNC per 100,000 person-years in the LDCT group and 12.9 deaths per 100,000 person-years in the CXR group (hazard ratio 0.80, 95% CI 0.42-1.52). CONCLUSIONS: Participants screened with LDCT had a modestly higher incidence of HNC. As uptake and adherence of lung cancer screening guidelines improve, clinicians should recognize that incidental findings from screening may lead to increased detection of HNC. LEVEL OF EVIDENCE: 3 Laryngoscope, 132:1609-1614, 2022.

Modeling oral cancer screening in the United States population.

OBJECTIVES: To evaluate the impact of oral cancer screening if applied to the United States (US) population or various high-risk populations in the US. METHODS: We modeled the effects of applying an oral cancer screening program to the US population assuming a similar mortality reduction as seen in the randomized Kerala trial. We combined data on the incidence of oral cancer in the Surveillance, End Results, and Epidemiology database, data on the relative risk in various high-risk groups from the Prostate, Lung, Cervical, and Ovarian screening trial, and the National Lung Screening Trial and data on the prevalence of cigarette use from the National Health Interview Survey. RESULTS: When extrapolating to the US population we predict the number needed to screen to prevent one oral cancer death (NNS) = 9,845 in all individuals aged 35 + . Screening efficiency would increase if applied to higher-risk populations. If oral cancer screening were applied to male ≥ 60 pack-year current smokers or former smokers who have quit within 15 years aged 50-79 we predict a 4.6% reduction in oral cancer mortality with an NNS = 1,485. CONCLUSIONS: Targeted screening of individuals at high risk for oral cancer has the potential to maximize the efficiency of screening and meaningfully impact oral cancer mortality. We suggest a future screening trial in high-risk individuals be considered to clarify the role of oral cancer screening in the US.

Incidence of Second Primary Lung Cancer After Low-Dose Computed Tomography vs Chest Radiography Screening in Survivors of Head and Neck Cancer: A Secondary Analysis of a Randomized Clinical Trial.

Importance: In head and neck cancer survivors, lung cancer screening may aid in detecting a second primary lung cancer or metastatic head and neck cancer earlier in the course of disease, which may improve treatment outcomes. However, no randomized data exist to assess the value of lung cancer screening in this population. Objective: To evaluate the incidence of second primary lung cancer in survivors of head and neck cancer survivors with screening low-dose computed tomography (CT) vs chest radiography (CXR). Design, Setting and Participants: For this ad hoc secondary analysis of a randomized clinical trial, head and neck cancer survivors were identified from the National Lung Screening Trial, which enrolled participants from August 2002 to April 2004. This randomized clinical trial compared screening using low-dose CT chest vs CXR in patients aged 55 to 74 years with at least a 30 pack-year history of cigarette smoking and who were current smokers or had quit within the past 15 years and who were at high risk for lung cancer. The incidences of second primary lung cancer and second primary head and neck cancer were compared with screening using low-dose CT vs CXR. Data were analyzed from December 1, 2020, to June 30, 2021. Interventions: Screening low-dose CT of the chest vs CXR. Main Outcomes and Measures: The primary outcome was the incidence of a second primary lung cancer. Results: Among 53 452 enrolled participants, we identified 171 survivors of head and neck cancer, of whom 82 were screened with low-dose CT of the chest and 89 with CXR. Participants' mean (SD) age was 61 (5) years, and 132 were men (77.2%). The incidence of lung cancer was higher among head and neck cancer survivors compared with participants without head and neck cancer (2080 per 100 000 person-years [2.1%] vs 609 per 100 000 person-years [0.6%]; adjusted rate ratio, 2.54; 95% CI, 1.63-3.95). In head and neck cancer survivors, the incidence of second primary lung cancer was 2610 cases per 100 000 person-years in the low-dose CT group vs 1594 cases per 100 000 person-years in the CXR group (rate ratio, 1.55; 95% CI, 0.59-3.63). In head and neck cancer survivors, overall survival was 7.07 years with low-dose CT vs 6.66 years with CXR (log-rank P = .48). Conclusions and Relevance: The results of this ad hoc secondary analysis of a randomized clinical trial suggest that head and neck cancer survivors are at especially high risk for a second primary lung cancer. These findings underscore the importance of low-dose CT screening in head and neck cancer survivors with significant cigarette smoking history who are fit to undergo treatment with curative intent.