Early postoperative water exposure does not increase complications in cutaneous surgeries: A randomized, investigator-blinded, controlled trial.

BACKGROUND: Patients are often advised to keep the initial postoperative dressings dry and undisturbed for 24 to 72 hours. However, these requirements may result in significant disruption of patients' activities of daily living, such as bathing, leisure, and exercise. OBJECTIVE: Compare standard management of keeping wounds dry and covered (48 hours) with early (6 hours) postoperative water exposure. METHODS: Investigator-blinded, randomized (1:1), controlled trial evaluating rate of infection and additional outcomes of interest. RESULTS: Overall, 437 patients were randomized to either the early (6-hour) water exposure (n = 218) intervention group or the standard cohort (n = 219). The incidence of culture-proven infection in the intervention group (1.8%) was similar to the standard group (1.4%) (P > .99). There was also no difference in rates of bleeding or bruising. Scar assessment using the Patient and Observer Scar Assessment Scale revealed similar scar outcomes. LIMITATIONS: Single site, academic center. CONCLUSION: Surgical wounds can be allowed to get wet in the immediate postoperative period with no increased incidence of infection or other complications and with similar cosmesis.

Rosacea Core Domain Set for Clinical Trials and Practice: A Consensus Statement.

Importance: Inconsistent reporting of outcomes in clinical trials of rosacea is impeding and likely preventing accurate data pooling and meta-analyses. There is a need for standardization of outcomes assessed during intervention trials of rosacea. Objective: To develop a rosacea core outcome set (COS) based on key domains that are globally relevant and applicable to all demographic groups to be used as a minimum list of outcomes for reporting by rosacea clinical trials, and when appropriate, in clinical practice. Evidence Review: A systematic literature review of rosacea clinical trials was conducted. Discrete outcomes were extracted and augmented through discussions and focus groups with key stakeholders. The initial list of 192 outcomes was refined to identify 50 unique outcomes that were rated through the Delphi process Round 1 by 88 panelists (63 physicians from 17 countries and 25 patients with rosacea in the US) on 9-point Likert scale. Based on feedback, an additional 11 outcomes were added in Round 2. Outcomes deemed to be critical for inclusion (rated 7-9 by ≥70% of both groups) were discussed in consensus meetings. The outcomes deemed to be most important for inclusion by at least 85% of the participants were incorporated into the final core domain set. Findings: The Delphi process and consensus-building meetings identified a final core set of 8 domains for rosacea clinical trials: ocular signs and symptoms; skin signs of disease; skin symptoms; overall severity; patient satisfaction; quality of life; degree of improvement; and presence and severity of treatment-related adverse events. Recommendations were also made for application in the clinical setting. Conclusions and Relevance: This core domain set for rosacea research is now available; its adoption by researchers may improve the usefulness of future trials of rosacea therapies by enabling meta-analyses and other comparisons across studies. This core domain set may also be useful in clinical practice.

Treatment of Periorbital Vascularity, Erythema, and Hyperpigmentation.

Periorbital hyperpigmentation (POH) is a common aesthetic concern that impacts patients' emotional well-being and quality of life. POH can be difficult to manage as the etiology is often multifactorial or difficult to elucidate. An understanding of different contributing factors and ability to classify hyperpigmentation can aid in the management of POH. Classification of POH is divided into pigmented, vascular, structural, and mixed subtypes. A wide array of treatment options has been proposed belying the challenges inherent to improving POH. Modalities vary from topical therapies, chemical peels, dermal fillers, and lasers, to surgical intervention. Because POH can be multifactorial, successful management of POH will depend on elucidating the etiology and often requires a combination of therapies.

Treatment of Periorbital Vascularity, Erythema, and Hyperpigmentation.

Periorbital hyperpigmentation (POH) is a common aesthetic concern that impacts patients' emotional well-being and quality of life. POH can be difficult to manage as the etiology is often multifactorial or difficult to elucidate. An understanding of different contributing factors and ability to classify hyperpigmentation can aid in the management of POH. Classification of POH is divided into pigmented, vascular, structural, and mixed subtypes. A wide array of treatment options has been proposed belying the challenges inherent to improving POH. Modalities vary from topical therapies, chemical peels, dermal fillers, and lasers, to surgical intervention. Because POH can be multifactorial, successful management of POH will depend on elucidating the etiology and often requires a combination of therapies.

Evidence-Based Clinical Practice Guidelines for Extramammary Paget Disease.

IMPORTANCE: Extramammary Paget disease (EMPD) is a frequently recurring malignant neoplasm with metastatic potential that presents in older adults on the genital, perianal, and axillary skin. Extramammary Paget disease can precede or occur along with internal malignant neoplasms. OBJECTIVE: To develop recommendations for the care of adults with EMPD. EVIDENCE REVIEW: A systematic review of the literature on EMPD from January 1990 to September 18, 2019, was conducted using MEDLINE, Embase, Web of Science Core Collection, and Cochrane Libraries. Analysis included 483 studies. A multidisciplinary expert panel evaluation of the findings led to the development of clinical care recommendations for EMPD. FINDINGS: The key findings were as follows: (1) Multiple skin biopsies, including those of any nodular areas, are critical for diagnosis. (2) Malignant neoplasm screening appropriate for age and anatomical site should be performed at baseline to distinguish between primary and secondary EMPD. (3) Routine use of sentinel lymph node biopsy or lymph node dissection is not recommended. (4) For intraepidermal EMPD, surgical and nonsurgical treatments may be used depending on patient and tumor characteristics, although cure rates may be superior with surgical approaches. For invasive EMPD, surgical resection with curative intent is preferred. (5) Patients with unresectable intraepidermal EMPD or patients who are medically unable to undergo surgery may receive nonsurgical treatments, including radiotherapy, imiquimod, photodynamic therapy, carbon dioxide laser therapy, or other modalities. (6) Distant metastatic disease may be treated with chemotherapy or individualized targeted approaches. (7) Close follow-up to monitor for recurrence is recommended for at least the first 5 years. CONCLUSIONS AND RELEVANCE: Clinical practice guidelines for EMPD provide guidance regarding recommended diagnostic approaches, differentiation between invasive and noninvasive disease, and use of surgical vs nonsurgical treatments. Prospective registries may further improve our understanding of the natural history of the disease in primary vs secondary EMPD, clarify features of high-risk tumors, and identify superior management approaches.

Ultrasound-guided foam sclerotherapy is safe and effective in the management of superficial venous insufficiency of the lower extremity.

BACKGROUND: Superficial venous disease of the lower extremity has a significant impact on quality of life. Both truncal and tributary vein reflux contribute to this disease process. Endovenous foam sclerotherapy is a widely used technique throughout the world for the management of superficial venous reflux and ultrasound guidance improves its safety and efficacy. METHODS: A PubMed search for ultrasound-guided foam sclerotherapy (UGFS) was conducted and all abstracts were reviewed to identify clinical trials and systematic reviews for a full-text analysis. Additional articles were also identified through searching the references of the selected studies. RESULTS: The production of foam for sclerotherapy in a 1:3 or 1:4 ratio of air to sclerosant is optimal in a low silicone, low-volume syringe system. Physiologic gas may decrease any side effects, with the trade-off of decreased foam stability. Proper technique with appropriate sterility and cleansing protocols are paramount for safe and effective treatment. The technical success of UGFS for great saphenous vein disease is inferior to endothermal and surgical modalities and retreatment is more common. However, the clinical improvement in patient-reported quality of life is similar between these three modalities. When used for tributary veins in combination with endothermal approaches of the truncal veins, UGFS has high rates of success with excellent patient satisfaction. UGFS has demonstrated an excellent safety profile comparable with or superior to other modalities. CONCLUSIONS: With proper technique, UGFS is safe and effective for the management of superficial venous disease.

Core Outcome Set for Actinic Keratosis Clinical Trials.

Importance: Although various treatments have been found in clinical trials to be effective in treating actinic keratosis (AK), researchers often report different outcomes. Heterogeneous outcome reporting precludes the comparison of results across studies and impedes the synthesis of treatment effectiveness in systematic reviews. Objective: To establish an international core outcome set for all clinical studies on AK treatment using systematic literature review and a Delphi consensus process. Evidence Review: Survey study with a formal consensus process. The keywords actinic keratosis and treatment were searched in PubMed, Embase, CINAHL, and the Cochrane Library to identify English-language studies investigating AK treatments published between January 1, 1980, and July 13, 2015. Physician and patient stakeholders were nominated to participate in Delphi surveys by the Measurement of Priority Outcome Variables in Dermatologic Surgery Steering Committee members. All participants from the first round were invited to participate in the second round. Outcomes reported in randomized controlled clinical trials on AK treatment were rated via web-based e-Delphi consensus surveys. Stakeholders were asked to assess the relative importance of each outcome in 2 Delphi survey rounds. Outcomes were provisionally included, pending the final consensus conference, if at least 70% of patient or physician stakeholders rated the outcome as critically important in 1 or both Delphi rounds and the outcome received a mean score of 7.5 from either stakeholder group. Data analysis was performed from November 5, 2018, to February 27, 2019. Findings: A total of 516 outcomes were identified by reviewing the literature and surveying key stakeholder groups. After deduplication and combination of similar outcomes, 137 of the 516 outcomes were included in the Delphi surveys. Twenty-one physicians and 12 patients participated in round 1 of the eDelphi survey, with 17 physicians (81%) retained and 12 patients (100%) retained in round 2. Of the 137 candidate outcomes, 9 met a priori Delphi consensus criteria, and 6 were included in the final outcomes set after a consensus meeting: complete clearance of AKs, percentage of AKs cleared, severity of adverse events, patient perspective on effectiveness, patient-reported future treatment preference, and recurrence rate. It was recommended that treatment response be assessed at 2 to 4 months and recurrence at 6 to 12 months, with the AK rate of progression to cutaneous squamous cell carcinoma reported whenever long-term follow-up was possible. Conclusions and Relevance: Consensus was reached regarding a core outcome set for AK trials. Further research may help determine the specific outcome measures used to assess each of these outcomes.

Sebaceous carcinoma: evidence-based clinical practice guidelines.

Sebaceous carcinoma usually occurs in adults older than 60 years, on the eyelid, head and neck, and trunk. In this Review, we present clinical care recommendations for sebaceous carcinoma, which were developed as a result of an expert panel evaluation of the findings of a systematic review. Key conclusions were drawn and recommendations made for diagnosis, first-line treatment, radiotherapy, and post-treatment care. For diagnosis, we concluded that deep biopsy is often required; furthermore, differential diagnoses that mimic the condition can be excluded with special histological stains. For treatment, the recommended first-line therapy is surgical removal, followed by margin assessment of the peripheral and deep tissue edges; conjunctival mapping biopsies can facilitate surgical planning. Radiotherapy can be considered for cases with nerve or lymph node involvement, and as the primary treatment in patients who are ineligible for surgery. Post-treatment clinical examination should occur every 6 months for at least 3 years. No specific systemic therapies for advanced disease can be recommended, but targeted therapies and immunotherapies are being developed.

Evidence-Based Clinical Practice Guidelines for Microcystic Adnexal Carcinoma: Informed by a Systematic Review.

IMPORTANCE: Microcystic adnexal carcinoma (MAC) occurs primarily in older adults of white race/ethnicity on sun-exposed skin of the head and neck. There are no formal guiding principles based on expert review of the evidence to assist clinicians in providing the highest-quality care for patients. OBJECTIVE: To develop recommendations for the care of adults with MAC. EVIDENCE REVIEW: A systematic review of the literature (1990 to June 2018) was performed using MEDLINE, Embase, Web of Science, and the Cochrane Library. The keywords searched were microcystic adnexal carcinoma, sclerosing sweat gland carcinoma, sclerosing sweat duct carcinoma, syringomatous carcinoma, malignant syringoma, sweat gland carcinoma with syringomatous features, locally aggressive adnexal carcinoma, and combined adnexal tumor. A multidisciplinary expert committee critically evaluated the literature to create recommendations for clinical practice. Statistical analysis was used to estimate optimal surgical margins. FINDINGS: In total, 55 studies met our inclusion criteria. The mean age of 1968 patients across the studies was 61.8 years; 54.1% were women. Recommendations were generated for diagnosis, treatment, and follow-up of MAC. There are 5 key findings of the expert committee based on the available evidence: (1) A suspect skin lesion requires a deep biopsy that includes subcutis. (2) MAC confined to the skin is best treated by surgery that examines the surrounding and deep edges of the tissue removed (Mohs micrographic surgery or complete circumferential peripheral and deep margin assessment). (3) Radiotherapy can be considered as an adjuvant for MAC at high risk for recurrence, surgically unresectable tumors, or patients who cannot have surgery for medical reasons. (4) Patients should be seen by a physician familiar with MAC every 6 to 12 months for the first 5 years after treatment. Patient education on photoprotection, periodic skin self-examination, postoperative healing, and the possible normal changes in local sensation (eg, initial hyperalgesia) should be considered. (5) There is limited evidence to guide the treatment of metastasis in MAC due to its rarity. Limitations of our findings are that the medical literature on MAC comprises only retrospective reviews and descriptions of individual patients and there are no controlled studies to guide management. CONCLUSIONS AND RELEVANCE: The presented clinical practice guidelines provide an outline for the diagnosis and management of MAC. Future efforts using multi-institutional registries may improve our understanding of the natural history of the disease in patients with lymph node or nerve involvement, the role of radiotherapy, and the treatment of metastatic MAC with drug therapy.

Assessing Skin Biopsy Rates for Histologic Findings Indicative of Nonpathological Cutaneous Disease.

BACKGROUND: Recent increase in skin biopsies has been attributed to an epidemic of skin cancer. This may be avoidable, with potential savings. OBJECTIVE: To determine whether the increase in skin biopsies is attributable to increasing frequency of biopsies associated with histology lacking pathological cutaneous disease. Pathological cutaneous disease was defined as (1) a malignancy, precancerous lesion, or lesion of uncertain behavior; or (2) disease symptomatic or associated with adverse quality of life impact. PATIENTS AND METHODS: Retrospective cohort study, 2006 to 2013 of dermatology practice serving Florida and Ohio. Data were a consecutive sample of skin biopsies for diagnosis of dermatologic disease. RESULTS: A total of 267,706 biopsies by an average of 52 providers per month from January 06 to December 13 were analyzed. Number of biopsies per visit increased 2% per year (RR: 1.02, CI: 1.00-1.04). Likelihood of biopsy associated with histology indicative of nonpathological cutaneous disease did not increase over time (OR: 0.99, CI: 0.95-1.03, p = .6302). CONCLUSION: Rates of biopsies associated with nonpathological cutaneous disease is not increasing. Overall biopsy rates per visit have gradually increased; this seems attributable to greater rates of detection of pathological dermatologic disease.

Patient-Centered Outcomes for Skin Cancer Management: Utilization of a Patient Delphi Process to Identify Important Treatment Themes.

BACKGROUND: Patient-reported outcomes are critical to research directed at maximizing patient benefit. The outcomes patients consider most relevant in the treatment of skin cancer have not been directly investigated. OBJECTIVE: To develop a ranked list of outcomes deemed most important by patients with skin cancer through a proctored Delphi process. METHODS: Twenty-one patients with a history of skin cancer volunteered to participate in the patient summit. The patient members participated in a guided discussion to generate a long list of potentially relevant outcomes. The list was then condensed and ranked through 2 rounds of a proctored Delphi process. RESULTS: Patients were diverse in their skin cancer histories and complexities, ages, and states of residence. Twelve themes were rated as highly important by 70% or more of participants. Most of these themes related to patient education and the collaborative nature of the physician-patient relationship. Fear of recurrence and cosmetic outcome were also highly rated. Limitations include a preponderance of older patients and patients from the midwest and northeast. CONCLUSION: Patients with skin cancer overwhelmingly prioritize a shared decision-making process, in which they are actively engaged and value detailed education regarding their disease. This should inform future research directed at skin cancer treatment and current physician-patient interactions.

Quantification of noninvasive fat reduction: A systematic review.

BACKGROUND AND OBJECTIVE: Noninvasive fat reduction appears effective, but there are various methods for quantifying changes. The objective of this review is to assess comparative utility measures of subcutaneous fat. STUDY DESIGN/MATERIALS AND METHODS: Articles describing noninvasive fat reduction were searched using MEDLINE, EMBASE, CINAHL and Scopus electronic databases on two dates (January 28, 2014 and February 16, 2016). Titles of studies and abstracts were screened for eligibility. Manual review was performed by two investigators to detect those that: (1) included original data; (2) were randomized controlled trials, or prospective or retrospective cohort studies; (3) quantified fat outcomes; and (4) enrolled at least 10 subjects. RESULTS: Of 1,057 retrieved articles, 36 met criteria. Most reported four or more measurement techniques. Circumference measurements were most commonly cited. Other objective techniques, like caliper thickness, ultrasound, magnetic resonance imaging (MRI), and three-dimensional (3D) photography, were also used. Common subjective methods were evaluation of standardized photographs by blinded raters and patient satisfaction surveys. CONCLUSIONS: For quantifying noninvasive fat reduction, all available methods had significant limitations: photographic comparisons were subjective; circumference or caliper measurements were confounded; ultrasound was operator dependent; MRI was expensive; computed models and simulations were in early development. As new technologies are developed, the need for reliable, accurate and practical measures of subcutaneous fat will increase. Lasers Surg. Med. 50:96-110, 2018. © 2017 Wiley Periodicals, Inc.

Development of a core outcome set for clinical trials in basal cell carcinoma: study protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey.

BACKGROUND: Basal cell carcinoma is the most common skin cancer worldwide. Treatment options include both surgical and topical modalities. Although risk of metastasis is low, basal cell carcinoma can be invasive and infiltrate important underlying structures such as bone or cartilage. While many clinical trials examining therapies for basal cell carcinoma exist, the lack of consensus in outcome reporting across all trials poses a concern. Proper evaluation and comparison of treatment modalities is challenging. In order to address the inconsistencies present, this project aims to determine a core set of outcomes which should be evaluated in all clinical trials of basal cell carcinoma. METHODS/DESIGN: Outcomes will be extracted over four phases: (1) a systematic literature review, (2) patient interviews, (3) other published sources, and (4) stakeholder involvement. Potential outcomes will then be examined by the Steering Committee, who may add or remove outcomes. The Delphi process will then be performed to condense the list of outcomes generated. Two rounds of Delphi surveys will be performed with two groups of participants - physicians and patients. A consensus meeting with relevant stakeholders will be conducted after the Delphi exercise to further select outcomes, taking into account participant scores. By the end of the meeting, members will vote and decide on a final recommended set of core outcomes. For the duration of the study, we will be in collaboration with both the Core Outcome Measures in Effectiveness Trials (COMET) initiative and the Cochrane Skin Group - Core Outcome Set Initiative (CSG-COUSIN). DISCUSSION: This study aims to develop a core outcome set to guide assessment in clinical trials on basal cell carcinoma. The end-goal is to improve the consistency of outcome reporting and allow proper evaluation of treatment effectiveness.

Development of a core outcome set for clinical trials in squamous cell carcinoma: study protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey.

BACKGROUND: Squamous cell carcinoma (SCC) is a common skin cancer that poses a risk of metastasis. Clinical investigations into SCC treatment are common, but the outcomes reported are highly variable, omitted, or clinically irrelevant. The outcome heterogeneity and reporting bias of these studies leave clinicians unable to accurately compare studies. Core outcome sets (COSs) are an agreed minimum set of outcomes recommended to be measured and reported in all clinical trials of a given condition or disease. Although COSs are under development for several dermatologic conditions, work has yet to be done to identify core outcomes specific for SCC. METHODS/DESIGN: Outcome extraction for COS generation will occur via four methods: (1) systematic literature review; (2) patient interviews; (3) other published sources; and (4) input from stakeholders in medicine, pharmacy, and other relevant industries. The list of outcomes will be revaluated by the Measuring PRiority Outcome Variables via Excellence in Dermatologic surgery (IMPROVED) Steering Committee. Delphi processes will be performed separately by expert clinicians and patients to condense the list of outcomes generated. A consensus meeting with relevant stakeholders will be conducted after the Delphi exercise to further select outcomes, taking into account participant scores. At the end of the meeting, members will vote and decide on a final recommended set of core outcomes. The Core Outcome Measures in Effectiveness Trials (COMET) organization and the Cochrane Skin Group - Core Outcome Set Initiative (CSG-COUSIN) will serve as advisers throughout the COS generation process. DISCUSSION: Comparison of clinical trials via systematic reviews and meta-analyses is facilitated when investigators study outcomes that are relevant and similar. The aim of this project is to develop a COS to guide use for future clinical trials.

A Systematic Review of Completeness of Reporting in Randomized Controlled Trials in Dermatologic Surgery: Adherence to CONSORT 2010 Recommendations.

BACKGROUND: Randomized controlled trials are the gold standard for comparing safety and effectiveness of surgical interventions. Reporting guidelines are available for conveying the results of such trials. OBJECTIVE: To assess adherence to standard reporting guidelines among randomized controlled trials in dermatologic surgery. MATERIALS AND METHODS: Systematic review. Data source was randomized controlled trials in the journal Dermatologic Surgery, per PubMed search, 1995 to 2014. Studies were appraised for the number of the 37 CONSORT 2010 Checklist criteria reported in each. Analysis included comparison of reporting across 4 consecutive periods. RESULTS: Three hundred sixty-three studies were eligible. The mean number of items reported per study increased monotonically from 14.5 in 1995 to 1999 to 16.2 in 2002 to 2004, 17.7 in 2005 to 2009, and 18.0 in 2010 to 2014 (p < .0001). A limitation was that study procedures may have been performed without being reported. CONCLUSION: Completeness of reporting in randomized controlled trials in dermatologic surgery has improved significantly during the preceding 2 decades. Some elements are still reported at lower rates.

Development of a core outcome set for clinical trials in rosacea: study protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey.

BACKGROUND: Rosacea is a chronic inflammatory disorder affecting millions of individuals worldwide. Diagnosis is based on signs and symptoms with management and treatment aimed to suppress inflammatory lesions, erythema, and telangiectasia. While many clinical trials of rosacea exist, the lack of consensus in outcome reporting across all trials poses a concern. Proper evaluation and comparison of treatment modalities is challenging. In order to address the inconsistencies present, this project aims to determine a core set of outcomes which should be evaluated in all clinical trials of rosacea. METHODS/DESIGN: This project will utilize a methodology similar to previous core outcome set research. A long list of outcomes will be extracted over four phases: (1) systematic literature review, (2) patient interviews, (3) other published sources, and (4) stakeholder involvement. Potential outcomes will be examined by the Steering Committee to provide further insight. The Delphi process will then be performed to prioritize and condense the list of outcomes generated. Two homogenous groups of physicians and patients will participate in two consecutive rounds of Delphi surveys. A consensus meeting, composed of physicians, patients, and stakeholders, will be conducted after the Delphi exercise to further select outcomes, taking into account participant scores. By the end of the meeting, members will vote and decide on a final recommended set of core outcomes. For the duration of the study, we will be in collaboration with both the Core Outcome Measures in Effectiveness Trials (COMET) and Cochrane Skin Group - Core Outcome Set Initiative (CSG-COUSIN). DISCUSSION: This study aims to develop a core outcome set to guide assessment in clinical trials of rosacea. The end-goal is to improve the reliability and consistency of outcome reporting, thereby allowing sufficient evaluation of treatment effectiveness and patient satisfaction.

Practice and Educational Gaps in Light, Laser, and Energy Treatments.

This article discusses current practice in laser dermatology, the gaps in practice, and recommendations for improvement. As is the case with other areas of cosmetic dermatology, there is a rapid development of new laser and light devices with limited epidemiologic data available to inform best practice. The high fixed cost associated with new laser devices, limited space available in some practices, and inconsistent training may limit the adoption of needed therapies. Improving research in this area; training opportunities for physicians, residents, and staff; and cost-effective laser/light device rentals programs could improve quality of current practice.