Observational study to estimate the proportion of surgical site infection following excision of ulcerated skin tumours (OASIS study).

BACKGROUND: Ulceration is a recognized risk factor for surgical site infection (SSI); however, the proportion of patients developing SSI after excision of an ulcerated skin cancer is unknown. AIM: To determine the proportion of participants with SSI after surgical excision of an ulcerated skin cancer. A secondary aim was to assess feasibility outcomes to inform the design of a randomized controlled trial to investigate the benefits and harms of perioperative antibiotics following excision of ulcerated tumours. METHODS: This was a multicentre, prospective, observational study of patients undergoing excision of an ulcerated skin cancer between March 2019 and March 2020. Prior to surgical excision, surface swabs of the ulcerated tumours of participants recruited from one centre were undertaken to determine organism growth. At 4 weeks after surgery, all participants were e-mailed or posted the Wound Healing Questionnaire (WHQ) to determine whether they had developed SSI. RESULTS: In total, 148 participants were recruited 105 (70.9%) males; mean ± SD age 77.1 ± 12.3 years. Primary outcome data were available for 116 (78.4%) participants, of whom 35 (30.2%) were identified as having an SSI using the WHQ with a cutoff score of 8, and 47 (40.5%) were identified with a cutoff score of 6. Using the modified WHQ in participants with wounds left to heal by secondary intention, 33 (28.4%) and 43 (37.1%) were identified to have SSI respectively. CONCLUSION: This prospective evaluation of SSI identified with the WHQ following excision of ulcerated skin cancers demonstrated a high proportion with SSI. The WHQ was acceptable to patients; however, further evaluation is required to ensure validity in assessing skin wounds.

Levels of wound calprotectin and other inflammatory biomarkers aid in deciding which patients with a diabetic foot ulcer need antibiotic therapy (INDUCE study).

AIMS: Deciding if a diabetic foot ulcer is infected in a community setting is challenging without validated point-of-care tests. Four inflammatory biomarkers were investigated to develop a composite algorithm for mildly infected diabetic foot ulcers: venous white cell count, C-reactive protein (CRP) and procalcitonin, and a novel wound exudate calprotectin assay. Calprotectin is a marker of neutrophilic inflammation. METHODS: In a prospective study, people with uninfected or mildly infected diabetic foot ulcers who had not received oral antibiotics in the preceding 2 weeks were recruited from community podiatry clinics for measurement of inflammatory biomarkers. Antibiotic prescribing decisions were based on clinicians' baseline assessments and participants were reviewed 1 week later; ulcer infection was defined by clinicians' overall impression from their two assessments. RESULTS: Some 363 potential participants were screened, of whom 67 were recruited, 29 with mildly infected diabetic foot ulcers and 38 with no infection. One participant withdrew early in each group. Ulcer area was 1.32 cm2 [interquartile range (IQR) 0.32-3.61 cm2 ] in infected ulcers and 0.22 cm2 (IQR 0.09-1.46 cm2 ) in uninfected ulcers. Baseline CRP for mild infection was 9.00 mg/ml and 6.00 mg/ml for uninfected ulcers; most procalcitonin levels were undetectable. Median calprotectin level in infected diabetic foot ulcers was 1437 ng/ml and 879 ng/ml in uninfected diabetic foot ulcers. Area under the receiver operating characteristic curve for a composite algorithm incorporating calprotectin, CRP, white cell count and ulcer area was 0.68 (95% confidence intervals 0.52-0.82), sensitivity 0.64, specificity 0.81. CONCLUSIONS: A composite algorithm including CRP, calprotectin, white cell count and ulcer area may help to distinguish uninfected from mildly infected diabetic foot ulcers. Venous procalcitonin is unhelpful for mild diabetic foot ulcer infection.

Development and evaluation by a cluster randomised trial of a psychosocial intervention in children and teenagers experiencing diabetes: the DEPICTED study.

OBJECTIVE: To develop and evaluate a health-care communication training programme to help diabetes health-care professionals (HCPs) counsel their patients more skilfully, particularly in relation to behaviour change. DESIGN: The HCP training was assessed using a pragmatic, cluster randomised controlled trial. The primary and secondary analyses were intention-to-treat comparisons of outcomes using multilevel modelling to allow for cluster (service) and individual effects, and involved two-level linear models. SETTING: Twenty-six UK paediatric diabetes services. PARTICIPANTS: The training was delivered to HCPs (doctors, nurses, dietitians and psychologists) working in paediatric diabetes services and the effectiveness of this training was measured in 693 children aged 4-15 years and families after 1 year (95.3% follow-up). INTERVENTIONS: A blended learning programme was informed by a systematic review of the literature, telephone and questionnaire surveys of professional practice, focus groups with children and parents, experimental consultations and three developmental workshops involving a stakeholder group. The programme focused on agenda-setting, flexible styles of communication (particularly guiding) and a menu of strategies using web-based training and practical workshops. MAIN OUTCOME MEASURES: The primary trial outcome was a change in glycosylated haemoglobin (HbA1c) levels between the start and finish of a 12-month study period. Secondary trial outcomes included change in quality of life, other clinical [including body mass index (BMI)] and psychosocial measures (assessed at participant level as listed above) and cost (assessed at service level). In addition, patient details (HbA1c levels, height, weight, BMI, insulin regimen), health service contacts and patient-borne costs were recorded at each clinic visit, along with details of who patients consulted with, for how long, and whether or not patients consulted on their own at each visit. Patients and carers were also asked to complete an interim questionnaire assessing patient enablement (or feelings towards clinic visit for younger patients aged 7-10 years) at their first clinic visit following the start of the trial. The cost of the intervention included the cost of training intervention teams. RESULTS: Trained staff showed better skills than control subjects in agenda-setting and consultation strategies, which waned from 4 to 12 months. There was no effect on HbA1c levels (p = 0.5). Patients in intervention clinics experienced a loss of confidence in their ability to manage diabetes, whereas controls showed surprisingly reduced barriers (p = 0.03) and improved adherence (p = 0.05). Patients in intervention clinics reported short-term increased ability (p = 0.04) to cope with diabetes. Parents in the intervention arm experienced greater excitement (p = 0.03) about clinic visits and improved continuity of care (p = 0.01) without the adverse effects seen in their offspring. The mean cost of training was £13,145 per site or £2163 per trainee. There was no significant difference in total NHS costs (including training) between groups (p = 0.1). CONCLUSIONS: Diabetes HCPs can be trained to improve consultation skills, but these skills need reinforcing. Over 1 year, no benefits were seen in children, unlike parents, who may be better placed to support their offspring. Further modification of this training is required to improve outcomes that may need to be measured over a longer time to see effects. TRIAL REGISTRATION: Current Controlled Trials ISRCTN61568050. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 15, No. 29. See the HTA programme website for further project information.