Optimizing Surgical Wound Care in Obstetrics and Gynecology.

Importance: Obstetrics and gynecology (OB/GYN) accounts for at least half of all open abdominal surgeries performed. Rates of surgical wound complications after open procedures in OB/GYN range from 5% to 35%. Therefore, optimizing management of surgical wound complications has the potential to significantly reduce cost and morbidity. However, guidelines addressing best practices for wound care in OB/GYN are limited. Objective: The objectives of this review are to describe the fundamentals of wound healing and to evaluate available evidence addressing surgical wound care. Based on these data, we provide recommendations for management of extrafascial surgical wound dehiscence after OB/GYN procedures. Evidence Acquisition: Literature search was performed in PubMed, Medline, OVID, and the Cochrane database. Relevant guidelines, systematic reviews, and original research articles investigating mechanisms of wound healing, types of wound closure, and management of surgical wound complications were reviewed. Results: Surgical wound complications in OB/GYN are associated with significant cost and morbidity. One of the most common complications is extrafascial dehiscence, which may occur in the setting of hematomas, seromas, or infection. Management includes early debridement and treatment of any underlying infection until healthy granulation tissue is present. For wounds healing by secondary intention, advanced moisture retentive dressings reduce time to healing and are cost-effective when compared with conventional wet-to-dry gauze dressings. Negative pressure wound therapy can be applied to deeper wounds healing by secondary intention. Review of published evidence also supports the use of delayed reclosure to expedite wound healing for select patients. Conclusions: Optimizing surgical wound care has the potential to reduce the cost and morbidity associated with surgical wound complications in OB/GYN. Advanced moisture retentive dressings should be considered for wounds healing by secondary intention. Data support delayed reclosure for select patients, although further studies are needed.

Implementing venous leg ulcer education and clinical decision support: a quality improvement project.

BACKGROUND: Venous leg ulcers (VLU) require early identification and treatment to prevent further harm. Health care providers often fail to initiate evidenced-based VLU treatment promptly because of a lack of knowledge of VLU guidelines. PURPOSE: To improve early treatment for patients with VLUs presenting to outpatient clinic settings. METHODS: Plan-Do-Study-Act cycles were used for this quality improvement project. Virtual education and a comprehensive clinical decision support (CDS) order set were implemented. Outcome metrics included the rate of ankle-brachial index (ABI) testing, mechanical compression therapy, and home health service referrals for patients with VLUs. The frequency with which the CDS order set was used was also measured. RESULTS: Forty health care providers attended the virtual education sessions among 3 outpatient clinics. There was an increase in ankle-brachial index testing from pre (n = 7; 15.9%) to post (n = 10; 18.2%) (P = .796), but there was a decline in mechanical compression therapy from pre (n = 15; 34.1%) to post (n = 4; 7.3%) (P = .002) and home health service referrals from pre (n = 11; 25%) to post (n = 9; 16.4%) (P = .322). The CDS order set was used 9 times over 13 weeks. CONCLUSION: Future Plan-Do-Study-Act cycles will include completing in-person education and reducing the VLU CDS order set length. Future projects should consider these approaches when implementing evidence-based VLU guidelines.

Viral transport media for COVID-19 testing.

Precautionary measures of physical isolation, social distancing, and masks have all aided in controlling the spread of COVID-19. However, detection of the virus is crucial to implement isolation of infected individuals. This paper presents the innovative repurposing of lab materials, workspace, and personnel in response to the COVID-19-induced shutdown and consequential shortage of commercially made virus transport media (VTM). This method for VTM production highlights the ability of standard research labs to fulfill the needs of those affected by the pandemic and potential recurrence of outbreaks. Further, the collaboration of the various entities at The Ohio State University Wexner Medical Center (OSUWMC) allowed for efficient production and distribution of VTM tubes to facilitate mass COVID-19 testing. We propose that implementation of this process by university research labs would enable quicker interventions, potentially better outcomes, and prevention of further spread of disease.

Development and validation of the Karitane Family Outcomes Tool.

PURPOSE: The purpose of this study was to develop the Karitane Family Outcomes Tool (KFOT), a brief parent-report questionnaire to measure outcomes of Australian Early Parenting Centres (EPCs) and similar programmes worldwide. DESIGN AND METHODS: The study was conducted in two stages. In Stage One, an initial item pool (80 items) was developed via focus group discussions with clinical experts and parents. In Stage Two, three samples of parents were recruited (online community sample: n = 849, clinical sample 1: n = 141, clinical sample 2: n = 109). The online community sample completed the 80-items and then non-normally distributed items were culled, leaving a total item pool of 57 items. The online community sample was then split into two subsamples (subsample 1: n = 650, subsample 2: n = 199). Exploratory factor analysis (EFA) was then conducted on online community subsample 1 and confirmatory factor analysis (CFA) on online community subsample 2 and clinical sample 1. Using clinical sample 2, concurrent validity was assessed by examining correlations between KFOT factor scores with scores on the Parenting Stress Index. Finally, discriminant validity was assessed by examining the KFOTs sensitivity to change following EPC intervention and by comparing KFOT scores of clinical and community samples. RESULTS: EFA revealed 13 items loading onto three factors: "Parental feelings," "Reading cues & meeting the child's needs" and "Perceptions of child behaviour." The factor structure was confirmed using CFA in both the community and clinical samples. Significant differences on all three KFOT factors and on the total score were found between the clinical and community samples, suggesting that the scale is able to discriminate between clinical and nonclinical groups. Significant differences were also found between pre- and postintervention scores, and between pre- and follow-up scores, on all three KFOT factors, providing further indication of discriminant validity. The KFOT factors correlated in the expected direction with scores on the Parenting Stress Index, showing concurrent validity. PRACTICAL IMPLICATIONS: Results indicate that the KFOT is a brief, valid and reliable parent-report scale that can be used by nurses to evaluate outcomes of EPC and similar parenting programmes.

Suitability of the isolated chicken eye test for classification of extreme pH detergents and cleaning products.

A.I.S.E. investigated the suitability of the regulatory adopted ICE in vitro test method (OECD TG 438) with or without histopathology to identify detergent and cleaning formulations having extreme pH that require classification as EU CLP/UN GHS Category 1. To this aim, 18 extreme pH detergent and cleaning formulations were tested covering both alkaline and acidic extreme pHs. The ICE standard test method following OECD Test Guideline 438 showed good concordance with in vivo classification (83%) and good and balanced specificity and sensitivity values (83%) which are in line with the performances of currently adopted in vitro test guidelines, confirming its suitability to identify Category 1 extreme pH detergent and cleaning products. In contrast to previous findings obtained with non-extreme pH formulations, the use of histopathology did not improve the sensitivity of the assay whilst it strongly decreased its specificity for the extreme pH formulations. Furthermore, use of non-testing prediction rules for classification showed poor concordance values (33% for the extreme pH rule and 61% for the EU CLP additivity approach) with high rates of over-prediction (100% for the extreme pH rule and 50% for the additivity approach), indicating that these non-testing prediction rules are not suitable to predict Category 1 hazards of extreme pH detergent and cleaning formulations.

Suitability of histopathology as an additional endpoint to the Isolated Chicken Eye Test for classification of non-extreme pH detergent and cleaning products.

A.I.S.E. investigated the suitability of histopathological evaluations as an additional endpoint to the regulatory adopted ICE in vitro test method (OECD TG 438) to identify non-extreme pH detergent and cleaning products that require classification as EU CLP/UN GHS Category 1 (serious eye damage). To this aim, a total of 30 non-extreme pH products covering the range of in vivo classifications for eye irritation, and representing various product categories were tested. Epithelium vacuolation (mid and lower layers) and erosion (at least moderate) were found to be the most relevant histopathological effects induced by products classified in vivo as Category 1. Histopathology criteria specifically developed for non-extreme pH detergent and cleaning products were shown to correctly identify materials classified as Category 1 based on in vivo persistent effects, and to significantly increase the overall sensitivity of the standard ICE prediction model for Category 1 identification (to 75%) whilst maintaining a good concordance (73%). In contrast, use of EU CLP additivity approach for classification of mixtures was considerably less predictive, with a concordance of only 27%, and 100% over-predictions of non-Category 1 products. As such, use of histopathology as an addition to the ICE test method was found suitable to identify EU CLP/UN GHS Category 1 non-extreme pH detergent and cleaning products and to allow a better discrimination from Category 2 products.

A tiered approach to the use of alternatives to animal testing for the safety assessment of cosmetics: skin irritation.

Evaluation of the skin irritancy and corrosivity potential of an ingredient is a necessity in the safety assessment of cosmetic ingredients. To date, there are two formally validated alternatives to the rabbit Draize test for skin corrosivity in place, namely the rat skin transcutaneous electrical resistance (TER) assay and the Human Skin Model Test using EpiSkin, EpiDerm and SkinEthic reconstructed human epidermal equivalents. For skin irritation, EpiSkin, EpiDerm and SkinEthic are validated as stand-alone test replacements for the rabbit Draize test. Data from these tests are rarely considered in isolation and are evaluated in combination with other factors to establish the overall irritating or corrosive potential of an ingredient. In light of the deadlines established in the Cosmetics Directive for cessation of animal testing for cosmetic ingredients, a COLIPA scientific meeting was held in Brussels on 30th January, 2008 to review the use of alternative approaches and to set up a decision tree approach for their integration into tiered testing strategies for hazard and safety assessment of cosmetic ingredients and their use in products. In conclusion, the safety assessments for skin irritation/corrosion of new chemicals for use in cosmetics can be confidently accomplished using exclusively alternative methods.

A tiered approach to the use of alternatives to animal testing for the safety assessment of cosmetics: eye irritation.

The need for alternative approaches to replace the in vivo rabbit Draize eye test for evaluation of eye irritation of cosmetic ingredients has been recognised by the cosmetics industry for many years. Extensive research has lead to the development of several assays, some of which have undergone formal validation. Even though, to date, no single in vitro assay has been validated as a full replacement for the rabbit Draize eye test, organotypic assays are accepted for specific and limited regulatory purposes. Although not formally validated, several other in vitro models have been used for over a decade by the cosmetics industry as valuable tools in a weight of evidence approach for the safety assessment of ingredients and finished products. In light of the deadlines established in the EU Cosmetics Directive for cessation of animal testing for cosmetic ingredients, a COLIPA scientific meeting was held in Brussels on 30th January, 2008 to review the use of alternative approaches and to set up a decision-tree approach for their integration into tiered testing strategies for hazard and safety assessment of cosmetic ingredients and their use in products. Furthermore, recommendations are given on how remaining data gaps and research needs can be addressed.

Deep hypothermia and circulatory arrest in adults.

Brain protection during cardiopulmonary bypass has been the subject of intense research. Deep hypothermic circulatory arrest (DHCA) continues to be used for that goal during complex aortic arch and large intracranial aneurysm surgeries. The anesthetic management for adult patients undergoing these types of procedures requires specific knowledge and expertise. Based on our experience and review of the current literature, the authors highlight the key areas of the anesthetic plan, discussing the risk factors associated with adverse neurologic outcome as well as the rationale for decisions regarding specific monitors and medications. In the conclusion an anesthetic protocol for adult patients undergoing DHCA is suggested.

The ECVAM international validation study on in vitro tests for acute skin irritation: report on the validity of the EPISKIN and EpiDerm assays and on the Skin Integrity Function Test.

ECVAM sponsored a formal validation study on three in vitro tests for skin irritation, of which two employ reconstituted human epidermis models (EPISKIN, EpiDerm), and one, the skin integrity function test (SIFT), employs ex vivo mouse skin. The goal of the study was to assess whether the in vitro tests would correctly predict in vivo classifications according to the EU classification scheme, "R38" and "no label" (i.e. non-irritant). 58 chemicals (25 irritants and 33 non-irritants) were tested, having been selected to give broad coverage of physico-chemical properties, and an adequate distribution of irritancy scores derived from in vivo rabbit skin irritation tests. In Phase 1, 20 of these chemicals (9 irritants and 11 non-irritants) were tested with coded identities by a single lead laboratory for each of the methods, to confirm the suitability of the protocol improvements introduced after a prevalidation phase. When cell viability (evaluated by the MTT reduction test) was used as the endpoint, the predictive ability of both EpiDerm and EPISKIN was considered sufficient to justify their progression to Phase 2, while the predictive ability of the SIFT was judged to be inadequate. Since both the reconstituted skin models provided false predictions around the in vivo classification border (a rabbit Draize test score of 2), the release of a cytokine, interleukin-1alpha (IL-1alpha), was also determined. In Phase 2, each human skin model was tested in three laboratories, with 58 chemicals. The main endpoint measured for both EpiDerm and EPISKIN was cell viability. In samples from chemicals which gave MTT assay results above the threshold of 50% viability, IL-1alpha release was also measured, to determine whether the additional endpoint would improve the predictive ability of the tests. For EPISKIN, the sensitivity was 75% and the specificity was 81% (MTT assay only); with the combination of the MTT and IL-1alpha assays, the sensitivity increased to 91%, with a specificity of 79%. For EpiDerm, the sensitivity was 57% and the specificity was 85% (MTT assay only), while the predictive capacity of EpiDerm was not improved by the measurement of IL-1alpha release. Following independent peer review, in April 2007 the ECVAM Scientific Advisory Committee endorsed the scientific validity of the EPISKIN test as a replacement for the rabbit skin irritation method, and of the EpiDerm method for identifying skin irritants as part of a tiered testing strategy. This new alternative approach will probably be the first use of in vitro toxicity testing to replace the Draize rabbit skin irritation test in Europe and internationally, since, in the very near future, new EU and OECD Test Guidelines will be proposed for regulatory acceptance.

Thanks, MR Blair, for wasting the past three years of my life.

Three years ago last February I began my nurse training, giving up a lucrative career for a more fulfilling and family-friendly profession. Given that my husband and I had become accustomed to living on his income, we decided to start a family before my career took off.