Three wound-dressing strategies to reduce surgical site infection after abdominal surgery: the Bluebelle feasibility study and pilot RCT.

BACKGROUND: Surgical site infection (SSI) affects up to 20% of people with a primary closed wound after surgery. Wound dressings may reduce SSI. OBJECTIVE: To assess the feasibility of a multicentre randomised controlled trial (RCT) to evaluate the effectiveness and cost-effectiveness of dressing types or no dressing to reduce SSI in primary surgical wounds. DESIGN: Phase A - semistructured interviews, outcome measure development, practice survey, literature reviews and value-of-information analysis. Phase B - pilot RCT with qualitative research and questionnaire validation. Patients and the public were involved. SETTING: Usual NHS care. PARTICIPANTS: Patients undergoing elective/non-elective abdominal surgery, including caesarean section. INTERVENTIONS: Phase A - none. Phase B - simple dressing, glue-as-a-dressing (tissue adhesive) or 'no dressing'. MAIN OUTCOME MEASURES: Phase A - pilot RCT design; SSI, patient experience and wound management questionnaires; dressing practices; and value-of-information of a RCT. Phase B - participants screened, proportions consented/randomised; acceptability of interventions; adherence; retention; validity and reliability of SSI measure; and cost drivers. DATA SOURCES: Phase A - interviews with patients and health-care professionals (HCPs), narrative data from published RCTs and data about dressing practices. Phase B - participants and HCPs in five hospitals. RESULTS: Phase A - we interviewed 102 participants. HCPs interpreted 'dressing' variably and reported using available products. HCPs suggested practical/clinical reasons for dressing use, acknowledged the weak evidence base and felt that a RCT including a 'no dressing' group was acceptable. A survey showed that 68% of 1769 wounds (727 participants) had simple dressings and 27% had glue-as-a-dressing. Dressings were used similarly in elective and non-elective surgery. The SSI questionnaire was developed from a content analysis of existing SSI tools and interviews, yielding 19 domains and 16 items. A main RCT would be valuable to the NHS at a willingness to pay of £20,000 per quality-adjusted life-year. Phase B - from 4 March 2016 to 30 November 2016, we approached 862 patients for the pilot RCT; 81.1% were eligible, 59.4% consented and 394 were randomised (simple, n = 133; glue, n = 129; no dressing, n = 132); non-adherence was 3 out of 133, 8 out of 129 and 20 out of 132, respectively. SSI occurred in 51 out of 281 participants. We interviewed 55 participants. All dressing strategies were acceptable to stakeholders, with no indication that adherence was problematic. Adherence aids and patients' understanding of their allocated dressing appeared to be key. The SSI questionnaire response rate overall was 67.2%. Items in the SSI questionnaire fitted a single scale, which had good reliability (test-retest and Cronbach's alpha of > 0.7) and diagnostic accuracy (c-statistic = 0.906). The key cost drivers were hospital appointments, dressings and redressings, use of new medicines and primary care appointments. LIMITATIONS: Multiple activities, often in parallel, were challenging to co-ordinate. An amendment took 4 months, restricting recruitment to the pilot RCT. Only 67% of participants completed the SSI questionnaire. We could not implement photography in theatres. CONCLUSIONS: A main RCT of dressing strategies is feasible and would be valuable to the NHS. The SSI questionnaire is sufficiently accurate to be used as the primary outcome. A main trial with three groups (as in the pilot) would be valuable to the NHS, using a primary outcome of SSI at discharge and patient-reported SSI symptoms at 4-8 weeks. TRIAL REGISTRATION: Phase A - Current Controlled Trials ISRCTN06792113; Phase B - Current Controlled Trials ISRCTN49328913. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 39. See the NIHR Journals Library website for further project information. Funding was also provided by the Medical Research Council ConDuCT-II Hub (reference number MR/K025643/1).

Wound infections are common after surgery. Some are cured with simple treatment, but others may lead to serious problems. Reducing the risk of a wound infection is important. We do not know if the type of dressing, or not using a dressing, influences the risk of infection. A study that allocated patients to receive different dressings (or no dressing) would answer this question. We did preliminary research to explore whether or not such a study is possible. We interviewed doctors, nurses and patients about their views on dressings and a future study. We also described dressings currently being used in the NHS and found that simple dressings and tissue adhesive (glue) 'as-a-dressing' are used most frequently. We studied existing evidence and interviewed experts to develop a questionnaire, completed by patients, to identify wound infections after patients leave hospital and tested its accuracy. We also explored taking photographs of wounds. We investigated whether or not a major study would be worth the cost and designed a pilot study to test its feasibility. The pilot study recruited 394 patients undergoing abdominal operations in five NHS hospitals. These patients were allocated to have a simple dressing, glue-as-a-dressing or no dressing, and 92% received the allocated dressing method. Patients and their doctors and nurses found the dressing methods to be acceptable. We showed that the new patient questionnaire accurately identified infections. Patients or their carers also found it acceptable to photograph their wounds. Our research suggests that a future large study would be worth the investment and is possible.

Oncological outcomes of abdominoperineal resection for the treatment of low rectal cancer: A retrospective review of a single UK tertiary centre experience.

BACKGROUND: The use of abdominoperineal resection (APR) in the management of low rectal cancer has received criticism over high rates of incomplete resection due to tumour involvement at the circumferential resection margin. Extralevator abdominoperineal resection has been advocated as a means of improving complete resection. However, Extralevator abdominoperineal resection can result in increased cost, morbidity and reduced quality of life.This study aims to assess the histological features and long-term outcomes of patients undergoing standard abdominoperineal resection and discusses the potential role of Extralevator abdominoperineal resection in this cohort. METHOD: A retrospective review of a prospectively maintained database of rectal cancer patients at a single centre. Patients undergoing standard APR were included from 01/06/2007 to 31/05/2012 to allow a minimum 2-year follow-up. Data was collected on age, gender, co-morbidity, pre-operative stage, neo-adjuvant therapy, histology, recurrence and mortality. RESULTS: Seventy patients were identified (45 (64%) male, median age 67; (range 36-85)). 12 (17.1%) patients had a positive circumferential resection margin; 4 (6.1%) tumours were located anteriorly, 8 (11%) were located posteriorly or laterally and may potentially have been completely resected with extralevator abdomino-perineal resection, Number-needed to treat = 9. Positive circumferential resection margin was more common in advanced tumours (p < 0.001). Local recurrence was more common with positive circumferential resection margins (16.7% Vs 0%, p = 0.027), with no statistically significant difference in 5-year survival, although there was a tendency towards worse survival in these patients. CONCLUSION: Positive circumferential resection margin following APR resulted in significantly increased local recurrence with a trend towards poorer survival outcomes. Extralevator abdomino-perineal resection may have benefited some of these patients with locally advanced tumours and postero-lateral recurrences. However, this has to be balanced against exposing patients to increased risk of adverse events. We would recommend selective use of Extralevator abdominoperineal resection for locally advanced and node-positive tumours although further studies to help refine selection criteria are required with long-term follow-up.

Has integrated 18F FDG PET/CT improved staging, reduced early recurrence or increased survival in oesophageal cancer?

BACKGROUND: Survival in oesophageal cancer remains poor with high post-operative recurrence rates. PET/CT was introduced to the Three-Counties Cancer Network (3CCN) in 2006 to detect 'occult' metastatic disease not seen with conventional staging modalities. This study aims to determine whether the introduction of Integrated fluorodeoxyglucose (18F) Positron Emission Tomography (PET/CT) has changed the management, improved survival or reduced the rate of early post-operative recurrence in patients with operable oesophageal cancer. METHODS: A retrospective review was undertaken of all patients diagnosed with oesophageal cancer in the 3CCN from 2005 to 2009. Early recurrence was defined as proven recurrence locally or at a distant site within one year of resection. RESULTS: 725 patients were identified. 200 (27.6%) patients underwent staging PET/CT. PET/CT altered treatment intent in 19 (9.5%) patients. 128 (17.7%) patients underwent oesophageal resection, 90 (70.3%) of which had a staging PET/CT. No significant difference was noted in post-operative mortality (4.4% Vs 5.3%, p = 0.8) or early recurrence where PET/CT was performed when adjusted for age, sex, stage or neo-adjuvant chemotherapy (p = 0.761, OR 1.136[95% CI 0.499-2.585]). PET/CT had no significant effect on survival (log-rank test; Chi-square 0.710, p = 0.4). CONCLUSION: PET/CT has improved the accuracy of oesophageal cancer staging avoiding potentially unnecessary surgery. Ultimately however, its use has had no effect on early recurrence or survival rates. Inaccurate identification of occult metastatic disease prior to the introduction of staging PET/CT does not appear to be the primary cause of early recurrence in patients with oesophageal cancer.

Emergency surgery in the elderly: challenges and solutions.

Elderly patients frequently present with surgical emergencies to health care providers, and outcomes in this group of patients remain poor. Contributing factors include frailty, preexisting comorbidity, polypharmacy, delayed diagnosis, and lack of timely and consultant-led treatment. In this review, we address common emergency surgical presentations in the elderly and highlight the specific challenges in caring for these patients. We summarize 20 years of reports by various medical bodies that have aimed to improve the care of these patients. To improve morbidity and mortality, several aspects of care need to be addressed. These include accurate and timely preoperative assessment to identify treatable pathology and, where possible, to consider and correct age-specific disease processes. Identification of patients in whom treatment would be futile or associated with high risk is needed to avoid unnecessary interventions and to give patients and carers realistic expectations. The use of multidisciplinary teams to identify common postoperative complications and age-specific syndromes is paramount. Prevention of complications is preferable to rescue treatment due to the high proportion of patients who fail to recover from adverse events. Even with successful surgical treatment, long-term functional decline and increased dependency are common. More research into emergency surgery in the elderly is needed to improve care for this growing group of vulnerable patients.