A Randomized Clinical Trial

[Posted 9/Nov/2022]

AUDIENCE: General Surgery, Family Medicine

KEY FINDINGS: Results of this trial showed that, compared with propofol, etomidate anesthesia did not increase overall major in-hospital morbidity after abdominal surgery in older patients, although it induced transient adrenocortical suppression.

BACKGROUND: Aim of this study is to test the primary hypothesis that etomidate vs propofol for anesthesia does not increase in-hospital morbidity after abdominal surgery in older patients.

DETAILS: This multicenter, parallel-group, noninferiority randomized clinical trial (Etomidate vs Propofol for In-hospital Complications [EPIC]) was conducted between August 15, 2017, and November 20, 2020, at 22 tertiary hospitals in China. Participants were aged 65 to 80 years and were scheduled for elective abdominal surgery. Patients and outcome assessors were blinded to group allocation. Data analysis followed a modified intention-to-treat principle. Primary outcome was a composite of major in-hospital postoperative complications (with a noninferiority margin of 3%). Secondary outcomes included intraoperative hemodynamic measurements; postoperative adrenocortical hormone levels; self-reported postoperative pain, nausea, and vomiting; and mortality at postoperative months 6 and 12. A total of 1944 participants were randomized, of whom 1917 (98.6%) completed the trial. Patients were randomized to the etomidate group (n = 967; mean [SD] age, 70.3 [4.0] years; 578 men [59.8%]) or propofol group (n = 950; mean [SD] age, 70.6 [4.2] years; 533 men [56.1%]). The primary end point occurred in 90 of 967 patients (9.3%) in the etomidate group and 83 of 950 patients (8.7%) in the propofol group, which met the noninferiority criterion (risk difference [RD], 0.6%; 95% CI, -1.6% to 2.7%; P = .66). In the etomidate group, mean (SD) cortisol levels were lower at the end of surgery (4.8 [2.7] µg/dL vs 6.1 [3.4] µg/dL; P < .001), and mean (SD) aldosterone levels were lower at the end of surgery (0.13 [0.05] ng/dL vs 0.15 [0.07] ng/dL; P = .02) and on postoperative day 1 (0.14 [0.04] ng/dL vs 0.16 [0.06] ng/dL; P = .001) compared with the propofol group. No difference in mortality was observed between the etomidate and propofol groups at postoperative month 6 (2.2% vs 3.0%; RD, -0.8%; 95% CI, -2.2% to 0.7%) and 12 (3.3% vs 3.9%; RD, -0.6%; 95% CI, -2.3% to 1.0%). More patients had pneumonia in the etomidate group than in the propofol group (2.0% vs 0.3%; RD, 1.7%; 95% CI, 0.7% to 2.8%; P = .001). Results were consistent in the per-protocol population.

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Source: Lu, Z., Zheng, H., Chen, Z., et al. (2022). Effect of Etomidate vs Propofol for Total Intravenous Anesthesia on Major Postoperative Complications in Older Patients: A Randomized Clinical Trial. Lasers Surg. Med.. 2022; 157(10): 888-895. Published: October, 2022. DOI: 10.1001/jamasurg.2022.3338.

[Posted 17/May/2025]

AUDIENCE: General Surgery, Family Medicine

KEY FINDINGS: Sinus laser therapy (SiLaT) demonstrated superior early outcomes, including faster recovery, reduced pain, and fewer complications with earlier resumption of daily activities compared to the lay-open technique. However, recurrence rates remain similar, necessitating long-term studies to evaluate its effectiveness as a first-line treatment. These findings support the use of SiLaT as a day-case surgical procedure, for treating simple PS disease, particularly in young active patients seeking rapid recovery with minimal morbidity.

BACKGROUND: Pilonidal sinus (PS) predominantly impacts adolescent and young adult males. This condition may be asymptomatically or escalate to painful acute abscesses and recurrent discharge. Purpose of this study is to evaluate the early postoperative outcomes of laser therapy compared to the lay-open technique in the treatment of chronic pilonidal sinus disease.

DETAILS: Prospective randomized comparative study including 40 patients, divided into two equal groups: (a) The SiLaT group: PS treated with diode laser therapy (SiLaT) and (b) the lay-open group: PS treated with lay-open (sinotomy). Postoperative outcomes such as operative time, hospital stay, pain scores, healing time, complications, and recurrence rates were analyzed. Operative time was significantly shorter in the SiLaT group (18.4 ± 2.1 min vs. 26.2 ± 3.7 min, p = 0.022). Hospital stay was shorter in the SiLaT group (6.60 ± 1.47 h vs. 15.10 ± 5.52 h, p < 0.001). Pain scores were lower in the SiLaT group (2.30 ± 0.92 vs. 4.80 ± 1.01, p < 0.001). Wound healing was significantly faster in the SiLaT group (10.1 ± 2.7 days vs. 34.1 ± 15.1 days, p < 0.0001). Recurrence rates (p = 0.998) and surgical site infection (p = 1.00) were comparable among both groups.

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Source: Deen, M. S. E., Hassan, Y. M., Sorour, M. A., et al. A Comparitive Study Between Early Outcomes of Laser and Lay-Open Technique in Management of Simple Pilonidal Sinus. Lasers Surg. Med.. 2025; 57(4): 321-328. Published: April, 2025. DOI: 10.1002/lsm.70008.

[Posted 17/Oct/2024]

AUDIENCE: Emergency Medicine

KEY FINDINGS:

BACKGROUND: Over several days in late September 2024, Hurricane Helene caused extensive damage to the southeastern United States. The storm affected the Baxter International's North Cove facility in North Carolina, the largest manufacturer of peritoneal dialysis and intravenous solutions in the United States, halting production.

DETAILS: CDC is issuing this Health Alert Network (HAN) Health Advisory to inform healthcare providers, pharmacists, healthcare facility administrators, and state, tribal, local, and territorial health departments of a supply disruption of peritoneal dialysis (PD) and intravenous (IV) solutions from the Baxter International's North Cove facility in North Carolina, due to Hurricane Helene.

The supply disruption may impact patient care and require adjustments to the clinical management of patients. Healthcare providers, pharmacists, healthcare facility administrators, and state, tribal, local, and territorial health departments, regardless of supply chain disruptions, should immediately assess their supply and develop plans and mitigation strategies to reduce the impact on patient care.

This Health Advisory summarizes recommendations from the Food and Drug Administration (FDA); the Administration for Strategic Preparedness and Response Technical Resources, Assistance Center, and Information Exchange (ASPR TRACIE) ; the American Society of Health-System Pharmacists (ASHP); the American Society of Nephrology (ASN); and the American Society of Pediatric Nephrology (ASPN) among others, to address supply disruptions of PD and IV solutions.

Facilities can implement strategies early to conserve their fluid supplies and avoid waste to reduce the impact on services. Strategies must ensure patient safety, timely and effective safety notifications, and education of healthcare personnel and patients. Emergency medical and outpatient services must be included in these strategies.

Additional supply disruption may occur in the aftermath of Hurricane Milton.

Recommendations

Healthcare Providers, Pharmacists, and Healthcare Facility Administrators in Healthcare Facilities

• Assess inventory, supply, and conserve available IV solutions.
• Determine the type of IV solutions your pharmacy or facility uses, including expiration dates, and whether this supply disruption will impact your facility.
• Monitor current and future supplies of IV solutions at your facility.
• Report any potential shortages or interruptions to the Food and Drug Administration (FDA) at DrugShortages@fda.hhs.gov.
• Implement a facility-specific action plan to optimize the use of IV solutions using evidence-based fluid management protocols.
• Evaluate all protocols, including the clinical need to continue IV fluid replacement at every shift change, bag change, and during the transition of care unless clinically necessary.
• Ensure that advisory committees with appropriate authorities are established to determine complex issues in supply disruptions and allocation of limited resources and patient triage as needed.
• Use oral formulations when IV options are not available and when appropriate and safe.
• Identify safe and effective alternative IV options (e.g., working with a nearby facility or licensed manufacturer who is not affected by the supply disruption).
• Review standing orders, including drug records and order sets.
• Ensure thorough documentation of the situation, including consumption of IV solutions.
• See FDA's Temporary Policies for Compounding Certain Parenteral Drug Products, for compounders to help fill the gaps from the impact of Hurricane Helene on Baxter International's North Cove facility.
• Ensure multidisciplinary team involvement to determine and develop conservation and stewardship strategies using IV solutions in specific patient populations.
• Include providers from various expertise (including key outpatient settings such as emergency departments, hematology/oncology, ambulatory surgery centers, wound care centers, infusion centers, home healthcare, etc.), pharmacists, nurses, infection control, informatics, patient safety, supply chain leadership, and emergency preparedness.
• Provide education and training to healthcare providers regarding any changes in protocols.
• Communicate changes in current practice, disruption, new shortages, and action plan adjustments to hospital leadership and frontline staff.
• Communicate with patients to assess supplies and provide a mechanism to notify their providers of insufficient supplies.

Providers and Administrators in Dialysis Facilities

• Assess and monitor inventory of available PD solutions.
• Review current practices to identify changes that extend the PD solution supply safely.
• Monitor current and future supplies of PD solutions.
• Report any interruptions to the FDA at DrugShortages@fda.hhs.gov.

• Implement an action plan for emergency PD treatment protocols
• Assess emergency PD protocols.
• Ensure optimal PD catheter function and flow of all patients to maximize ultrafiltration and solute exchange (malposition, etc.).
• Optimize prescriptions; overall approaches should prioritize bag-sparing rather than solution-sparing.
• For example, consider changing dwell times rather than adding a PD solution bag if a prescription change is needed for a patient.
• Monitor patients closely after prescription adjustments, including phone check-ins.
• Communicate with patients receiving peritoneal dialysis at home and their care providers.
• Assess supplies and provide a mechanism to notify their provider of insufficient supplies.
• Provide education and training to patients and their care providers regarding any changes in PD bags or associated products (e.g., adaptors, tubing, etc.) used for their treatments.
• Consider options for individual patients, keeping safety in mind.
• Continuous ambulatory PD (CAPD) may be a good option for some patients.
• Transitioning to hemodialysis (HD) should be avoided as much as possible. However, if adjustment of PD prescription has been explored and exhausted, a temporary transition to HD may be necessary if the available supply is insufficient to provide adequate PD.
• Reinforce patient safety principles when not using usual products and procedures to prevent patient injury and medical errors.

State, Tribal, Local, and Territorial Health Departments

• Maintain situational awareness of the severity of the supply disruption and implement strategies.
• Where possible, facilitate communication across health systems within the jurisdictions related to acute supply needs.

Source: CDC Issues Health Alert In Light of Disruptions in Availability of PD and IV Solutions from Baxter International Facility in North Carolina. CDC. 2024; Published: October, 2024.

[Posted 22/Jul/2024]

AUDIENCE: General Surgery, Dermatology, Family Medicine

KEY FINDINGS: Skin graft reperfusion is a protracted process that evolves differently in the graft centre and periphery, influenced by postoperative time and anatomic location. A better knowledge of this process can potentially enhance the development of strategies to induce vessel ingrowth into tissue-engineered skin substitutes.

BACKGROUND: Under optimal conditions, afferent and efferent human skin graft microcirculation can be restored 8-12 days postgrafting. Still, the evidence about the reperfusion dynamics beyond this period in a dermato-oncologic setting is scant. Authors aimed to characterise the reperfusion of human skin grafts over 4 weeks according to the necrosis extension (less than 20%, or 20%-50%) and anatomic location using laser speckle contrast imaging (LSCI).

DETAILS: Over 16 months, all eligible adults undergoing skin grafts following skin cancer removal on the scalp, face and lower limb were enroled. Perfusion was assessed with LSCI on the wound margin (control skin) on day 0 and on the graft surface on days 7, 14, 21 and 28. Graft necrosis extension was determined on day 28. Forty-seven grafts of 47 participants were analysed. Regardless of necrosis extension, graft perfusion equalled the control skin by day 7, surpassed it by day 21, and stabilised onwards. Grafts with less than 20% necrosis on the scalp and lower limb shared this reperfusion pattern and had a consistently better-perfused centre than the periphery for the first 21 days. On the face, the graft perfusion did not differ from the control skin from day 7 onwards, and there were no differences in reperfusion within the graft during the study.

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Source: Pinho, A., Brinca, A., Xara, J., et al. (2024). Postoperative Time and Anatomic Location Influence Skin Graft Reperfusion Assessed With Laser Speckle Contrast Imaging. Lasers in Surgery and Medicine. 2024; 56(6): 564-573. Published: August, 2024. DOI: 10.1002/lsm.23815.

A Systematic Review

[Posted 20/May/2024]

AUDIENCE: Nursing

KEY FINDINGS: Despite the promising results for fascia iliaca compartment block and methylprednisolone, there is limited knowledge regarding evidence-based delirium prevention interventions. Most studies had small sample sizes indicating that the current evidence is exploratory. There is an urgent need for the funding and conduct of trials to test preventative interventions for older surgical patients at intermediate to high risk of developing delirium.

BACKGROUND: Few reviews have addressed delirium prevention among intermediate to high-risk older surgical patients. Purpose of this study is to map preoperative delirium prevention interventions for older surgical patients at intermediate to high risk of developing delirium, assess outcomes and identify gaps in knowledge.

DETAILS: A systematic search was conducted of the literature published from 1990 to October 2022 in Medline, CINAHL and Ageline and of the grey literature in Google Scholar. Randomised controlled trials were retrieved that assessed the effectiveness of preoperative delirium prevention interventions for older surgical patients at intermediate to high risk of delirium. Data were extracted using a data extraction tool, and results were tabulated. Studies were assessed for bias using the Cochrane Collaboration Risk of Bias tool. Twenty-one studies met the selection criteria including N = 5096 participants. Two studies tested cognitive training, two studies tested fascia iliaca compartment block and one study assessed femoral nerve block. Ten studies tested prophylactic medications including methylprednisolone. Five studies investigated geriatric assessment and management. One study assessed transcutaneous electrical acupoint stimulation. In the two studies testing fascia iliaca compartment block, there was a reduction in postoperative delirium for orthopaedic patients. Methylprednisolone reduced postoperative delirium in orthopaedic patients and in those undergoing gastrointestinal surgery. Results of all other interventions on the occurrence of postoperative delirium and additional outcomes including the severity and duration of delirium were inconclusive.

Copyright © John Wiley & Sons Ltd. All rights reserved.

Source: Lay, N., Foley, P., and Allen, J. (2024). The Effectiveness Of Preoperative Delirium Prevention In Intermediate To High-Risk Older Surgical Patients: A Systematic Review. J Clin Nurs. 2024; 33(5): 1666-1683. Published: May, 2024. DOI: 10.1111/jocn.17020.

A Real-World Clinical Study of 126 Patients

[Posted 19/Mar/2024]

AUDIENCE: General Surgery, Family Medicine

KEY FINDINGS: FMR is a safe and effective treatment modality for improving facial atrophic acne scars, and the number of FMR treatment sessions and pulse width are associated with clinical efficacy.

BACKGROUND: Purpose of this study is to analyze the clinical efficacy and safety of fractional microneedle radiofrequency (FMR) for facial atrophic acne scars in a real-world setting.

DETAILS: The clinical data of patients with atrophic acne scars who had received FMR therapy from February 2018 to August 2022 were retrospectively analyzed. The improvement of atrophic acne scars was assessed using the ECCA Grading Scale (échelle d'évaluation clinique des cicatrices d'acné), Global Aesthetic Improvement Scale (GAIS), and modified Manchester Scar Scale (mMSS). Adverse reactions during FMR treatment were also recorded. Univariate and multivariate logistic regression analyses were performed to evaluate the efficacy and safety of FMR for atrophic acne scars. A total of 126 patients with facial atrophic acne scars were included. A total of 590 FMR treatment sessions were accomplished, with each of 82 patients receiving 4 or more treatment sessions, and 1 receiving a maximum of 14 sessions. All patients showed improvement in symptoms after FMR treatment, with moderate to significant improvement (ECCA score reduction of 26%–100%) in 92 (73.0%) patients. As the number of treatment sessions increased, the ECCA score gradually decreased from an average of 85.6 before to 35.0 after FMR. The average scores for distortion, color, and visual analogue scale (VAS) of mMSS all showed certain reductions. The change in GAIS score indicated improvement after treatment, with minimal improvement in 16 patients (12.7%), good improvement in 57 patients (45.2%), significant improvement in 45 patients (35.7%), and optimal improvement in 8 patients (6.4%). The univariate and multivariate logistic regression analyses revealed that the long pulse width and the number of FMR treatment sessions were positively associated with clinical efficacy. Compared to the short pulse-width group (200 ms), the longer pulse-width group (300 ms) (odds ratio [OR] = 8.3, p = 0.003) and the even longer pulse-width group (400–500 ms) (OR = 52.6, p 0.001) demonstrated stronger efficacies. Patients who received more than three treatment sessions had better outcomes compared to those who received three or fewer treatment sessions (OR = 4.0, p = 0.036). All patients experienced posttreatment transient erythema, but no crusting, infection, or blister. Six cases developed grid-like erythema around 1 month posttreatment and one case experienced hyperpigmentation, both of which resolved within 1–3 months after appropriate management.

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Source: Ziwei, D., Yuan, G., Yuehong, G., et al. (2024). Efficacy and Safety of Fractional Microneedle Radiofrequency for Atrophic Acne Scars: A Real-World Clinical Study of 126 Patients. Lasers Surg. Med.. 2024; 56(2): 150-164. Published: February, 2024. DOI: 10.1002/lsm.23759.