Reported Outcome Measures in Mohs Micrographic Surgery in Studies With Defined Techniques for Embedding and Processing of Tissue: A Systematic Review.

BACKGROUND: Mohs micrographic surgery (MMS) is a technique that combines surgical excision and histologic evaluation to achieve higher cure rates for skin cancer than traditional surgical excision. Competing performance measures have fostered numerous histologic techniques for MMS. OBJECTIVE: To analyze differences in primary outcomes in the published literature regarding the technique of tissue processing and embedding during the MMS process. METHODS: A systematic review was performed of the published literature in MEDLINE, PubMed, Embase, and Cochrane library that included a description of the manipulation of tissue during the grossing and embedding steps of MMS. RESULTS: Inclusion criteria were met by 61 articles. Of these studies, the cure/recurrence rate was assessed in 1 article (1.6%), tissue conservation was assessed in 47 (77%), time-saving was assessed in 35 (57%), cost-saving was assessed in 6 (10%), and decreased artifact were assessed in 20 (33%). CONCLUSION: There is a lack of standardization for assessing clinical outcomes in the published literature regarding MMS process techniques. Cure is a critical outcome in studies comparing MMS processing methodologies.

Pain Intensity Assessment Scales for Dermatologic Surgery Patients: A Systematic Review.

BACKGROUND: Pain assessment plays an important role in dermatologic surgery. The numeric rating scale (NRS), visual analog scale (VAS), verbal rating scale (VRS), and Faces Pain Scale (FPS) are commonly used scales for pain measurement. Conflicting evidence exists regarding the use of each. Prompt pain recognition and treatment during procedures result in higher patient satisfaction. OBJECTIVE: Determine the most applicable scale for acute pain measurement in dermatologic surgery. MATERIALS AND METHODS: This systematic review was performed in accordance with PRISMA-Supplemental Digital Content 4, http://links.lww.com/DSS/A976 (PROSPERO; CRD42018091058). PubMed, Cochrane, EMBASE, Scopus, and Web of Science were searched between April 24, 2018, and May 06, 2018. The search query consisted of pain, pain measurement (NRS, VAS, VRS, and FPS), and assessment/comparison. The inclusion criteria included English language literature with primary/secondary outcome objectives directly comparing ≥2 pain scales in acute pain (age: 13+). Study end points included interscale correlations, patient preferences, provider preferences, study author recommendations, and failure rates. RESULTS: Eight hundred seven studies were retrieved: A total of 42 studies were included. The visual analog scale (n = 42) was most studied, followed by NRS (n = 29), VRS (n = 27), and FPS (n = 11). 93.1% studies showed a high statistical correlation between VAS and NRS. Patients preferred NRS (n = 8/11), followed by FPS (n = 3/11), VRS (n = 2/11), and VAS (n = 1/11). Study authors recommended NRS/VAS (n = 8/19), VRS (n = 6/19), and FPS (n = 1/19). Providers preferred NRS (n = 2/3) and VRS (n = 1/3). The visual analog scale had the highest failure rate (n = 11/12). CONCLUSION: The numeric rating scale is most applicable for dermatologic surgery because of reported patient and provider preferences, lowest failure rates, and most frequent study author recommendations.

Postoperative Infections in Dermatologic Surgery: The Role of Wound Cultures.

BACKGROUND: Dermatologic surgery is associated with low postoperative infection rates, averaging from approximately 1% to 4.25%. Often, postoperative infections are treated empirically based on clinical diagnosis of infection, given it can take 48 to 72 hours for a wound culture to identify a pathogen. OBJECTIVE: We aimed to evaluate the efficacy of empiric antibiotics in dermatologic surgery postoperative infections and if wound cultures change postoperative antibiotic therapy. METHODS: A 7-center, retrospective analysis of postoperative infections, with culture data, in dermatologic surgery patients was performed. RESULTS: Of 91 cases of clinically diagnosed postoperative infection, 82.4% (n = 75) were successfully treated with empiric oral antibiotics (95% confidence interval [0.73-0.89], p < .0001). In 16 (17.6%) cases, initial empiric antibiotics were unsuccessful, and wound culture results altered antibiotic therapy in 9 cases (9.9%) with 6 (6.6%) of these cases requiring additional coverage for methicillin-resistant Staphylococcus aureus (MRSA). CONCLUSION: Empiric antibiotic treatment is usually appropriate for patients with postoperative surgical-site infections with wound cultures altering antibiotic management in a minority of cases. When empiric antibiotics fail, lack of MRSA coverage is usually the cause; therefore, providers should be aware of local MRSA prevalence and susceptibilities.

Differential Analgesia From Vibratory Stimulation During Local Injection of Anesthetic: A Randomized Clinical Trial.

BACKGROUND: Inadequate pain reduction during anesthetic injection is a significant medical and surgical problem. Vibratory distraction reduces this pain; however, there are minimal data identifying those who respond best. OBJECTIVE: To quantify analgesia from vibration before anesthetic injection. MATERIALS AND METHODS: In this partially blinded, single-institution trial, adult participants were randomized to intervention (vibratory anesthetic device, VAD ON) or placebo (VAD OFF). Pain was assessed using the 11-point numeric rating scale (NRS). Relative reduction in NRS between VAD OFF and ON was used to identify minimum clinically important and substantially clinically important difference in pain. RESULTS: One hundred one tested sites from 87 subjects were assessed. Sixty-three percent were men with a median age of 66 years. From univariate analysis, males, subjects aged <60, and head and neck (HN) treated subjects had a significant reduction in NRS (p < .05). Multivariate analysis identified NRS reductions in females <60 (p = .012), males ≥70 (p = .002), females and males treated on HN (p = .048 and p = .035, respectively), and males ≥70 treated on HN (p = .012). Substantially clinically important difference (≥57% NRS reduction) included subjects <60, females <70, HN treatment aged 60 to 69, males ≥70, and females treated on HN. CONCLUSION: Vibratory anesthetic device reduces pain during anesthetic injection, primarily for HN treatments and older male subjects.

Effect of a Vibratory Anesthetic Device on Pain Anticipation and Subsequent Pain Perception Among Patients Undergoing Cutaneous Cancer Removal Surgery: A Randomized Clinical Trial.

IMPORTANCE: Vibration has been shown to decrease injection site pain in patients; however, to date, this effect has not been assessed for patients who catastrophize pain (ie, patients who anticipate a higher pain level). The anticipation of a pain score greater than 4 on the 11-point Numeric Rating Scale (NRS) has been associated with an increase in a patient's perception of procedural pain. OBJECTIVE: To assess the efficacy of vibration during cutaneous anesthetic injection for dermatologic surgery for patients who catastrophize pain (NRS score >4) and patients who do not (NRS score ≤4). DESIGN, SETTING, AND PARTICIPANTS: Randomized, parallel-group clinical trial from June 19 to September 4, 2018, at a tertiary dermatologic surgery clinic among 87 adults undergoing cutaneous cancer removal surgery. Patients completed a preprocedural questionnaire detailing their baseline pain, anticipated pain, and drug use. Analysis was performed on an intent-to-treat basis. INTERVENTIONS: Use of a vibratory anesthetic device (VAD) on the treatment site prior to anesthetic injection in the on (VAD ON) or off (VAD OFF) mode. MAIN OUTCOMES AND MEASURES: Pain was reported using the 11-point NRS (where 0 indicates no pain and 11 indicates the worst pain imaginable). A minimum clinically important difference of 22% or more and a substantial clinically important difference of 57% or more were used to assess the efficacy of vibration in patient-reported NRS score during anesthetic injection (iNRS score). RESULTS: A total of 87 patients were included, with 101 unique events reported (among the unique events, 37 were reported in women and 64 were reported in men; mean [SD] age, 66.0 [11.3] years). The mean (confidence level [CL]) iNRS score for patients who catastrophized pain was 2.27 (0.66) compared with 1.44 (0.39) for patients who did not (P = .03). A 38.9% decrease in mean (CL) iNRS score was reported with VAD ON compared with VAD OFF in all participants (1.24 [0.38] vs 2.04 [0.54]). Patients who catastrophized pain reported a 25.5% decrease in mean (CL) iNRS score with VAD ON vs VAD OFF (1.91 [0.99] vs 2.57 [0.98]), and patients who did not reported a 79.4% decrease (1.02 [0.40] vs 1.84 [0.66]). VAD ON was the only statistically significant variable to affect iNRS score (F statistic, 2.741; P = .03). CONCLUSIONS AND RELEVANCE: This trial demonstrates that those who catastrophize pain prior to a procedure report a higher perceived level of pain. The application of vibration during local anesthetic injection resulted in a minimum clinically important difference in pain level for patients who catastrophize pain and a substantial clinically important difference in pain level for patients who do not. LEVEL OF EVIDENCE: 2. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT03467685.

GBR 830, an anti-OX40, improves skin gene signatures and clinical scores in patients with atopic dermatitis.

BACKGROUND: GBR 830 is a humanized mAb against OX40, a costimulatory receptor on activated T cells. OX40 inhibition might have a therapeutic role in T cell-mediated diseases, including atopic dermatitis (AD). OBJECTIVE: This exploratory phase 2a study investigated the safety, efficacy, and tissue effects of GBR 830 in patients with AD. METHODS: Patients with moderate-to-severe AD (affected body surface area, ≥10%; Eczema Area and Severity Index score, ≥12; and inadequate response to topical treatments) were randomized 3:1 to 10 mg/kg intravenous GBR 830 or placebo on day 1 (baseline) and day 29. Biopsy specimens were collected (n = 40) at days 1, 29, and 71. Primary end points included treatment-emergent adverse events (TEAEs) and changes from baseline in biomarkers (epidermal hyperplasia/cytokines) at days 29 and 71. RESULTS: GBR 830 was well tolerated, with equal TEAE distribution (GBR 830, 63.0% [29/46]; placebo, 63.0% [10/16]). One serious TEAE in the GBR 830 group was deemed unrelated to study drug. At day 71, the proportion of intent-to-treat subjects achieving 50% or greater improvement in Eczema Area and Severity Index score was greater with GBR 830 (76.9% [20/26]) versus placebo (37.5% [3/8]). GBR 830 induced significant progressive reductions in TH1 (IFN-γ/CXCL10), TH2 (IL-31/CCL11/CCL17), and TH17/TH22 (IL-23p19/IL-8/S100A12) mRNA expression in lesional skin. Significant progressive reductions until day 71 in the drug group were seen in OX40+ T cells and OX40L+ dendritic cells (P < .001). Hyperplasia measures (thickness/keratin 16/Ki67) showed greater reductions with GBR 830 (P < .001). CONCLUSIONS: Two doses of GBR 830 administered 4 weeks apart were well tolerated and induced significant progressive tissue and clinical changes until day 71 (42 days after the last dose), highlighting the potential of OX40 targeting in patients with AD.