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.

A single-blinded randomised clinical trial of permissive underfeeding in patients requiring parenteral nutrition.

BACKGROUND & AIMS: The importance of adequate nutritional support is well established, but characterising what 'adequate nutrition' represents remains contentious. In recent years there has been increasing interest in the concept of 'permissive underfeeding' where patients are intentionally prescribed less nutrition than their calculated requirements. The aim of this study was to evaluate the effect of permissive underfeeding on septic and nutrition related morbidity in patients requiring short term parenteral nutrition (PN). METHODS: This was a single-blinded randomised clinical trial of 50 consecutive patients requiring parenteral nutritional support. Patients were randomized to receive either normocaloric or hypocaloric feeding (respectively 100% vs. 60% of estimated requirements). The primary end point was septic complications. Secondary end points included the metabolic, physiological and clinical outcomes to the two feeding protocols. RESULTS: Permissive underfeeding was associated with fewer septic complications (3 vs. 12 patients; p = 0.003), and a lower incidence of the systemic inflammatory response syndrome (9 vs. 16 patients; p = 0.017). Permissively underfed patients had fewer feed related complications (2 vs. 9 patients; p = 0.016). CONCLUSION: Permissive underfeeding in patients requiring short term PN appears to be safe and may results in reduced septic and feed-related complications. TRIAL REGISTRATION: NCT01154179 TRIAL REGISTRY: http://clinicaltrials.gov/ct2/show/NCT01154179.

Colonoscopy in the octogenarian population: diagnostic and survival outcomes from a large series of patients.

OBJECTIVE: Our aim was to audit the diagnostic and survival outcomes of colonoscopy in octogenarians and to determine if it confers any survival benefit. METHODS: A review of a prospectively maintained database over a two year period between October 2005 and September 2007 was undertaken. Data on numerous outcome variables and survival were collected and analysed. Categorical variables were compared using the Chi-square test. Kaplan-Meier survival curves were constructed and log rank test were used to compare survival curves. RESULTS: There were 1905 patients, of which 289 (15%) were over the age of 80 years. Caecal intubation was significantly lower in octogenarians when compared with young patients (239/289, (82%) vs. 1411/1616 (88%), p = 0.025). The most common reason for failure to intubate the caecum was presence of stenosing pathology in distal bowel (octogenarians 46% (23 out of 50 failed intubations) vs. young 23% (49 out of 205 failed intubations), p = 0.002). A greater proportion of octogenarians had poor bowel preparation when compared with the young (20% vs. 13%, p = 0.001). Significantly more pathology was detected in octogenarians (72% vs. 59%, p = 0.001). Forty-four (15.2%) octogenarians were found to have malignancy. Of these, only 23 (52%) underwent subsequent surgery. Median survival of octogenarians who had surgery was not statistically better (31 (IQR 12-38) months vs. 16 (IQR 5-31) months, p = 0.10) than those who did not. CONCLUSION: Colonoscopy is safe in octogenarians and provides a high yield. Our results suggest that it does not appear to result in any survival benefit. However, to establish this, further research with larger cohorts and longer follow-up periods would be required.

Could pre-mortem computerised tomography scans reduce the need for coroner's post-mortem examinations?

INTRODUCTION: Post-mortem examinations may result in considerable distress to the bereaved family. This audit was undertaken to examine whether computerised tomography (CT) scanning prior to death might reduce the need for post-mortems without compromising the accuracy of recording the cause of death. SUBJECTS AND METHODS: The case notes of 100 consecutive patients who had a coroner's post-mortem, because the cause of death was unknown, were reviewed by four senior clinicians. Along with the likely cause of death, the clinicians gave their opinion as to whether a CT scan would have enabled certification of death without the need for a post-mortem. Concordance between the post-mortem findings and the clinical events surrounding death was explored. RESULTS: It would have been possible to perform a pre-mortem CT scan on 90 of the 100 patients. A pre-mortem CT scan would have given the cause of death in 59 (66%) of these. In 30 patients, the cause of death established by the post-mortem was at variance with the clinical events surrounding death and clinically relevant information, such as recent surgery, was not recorded on the death certificates of 26 patients. CONCLUSIONS: The use of a pre-mortem CT scan and involvement of senior clinicians in the process of establishing cause of death will improve the accuracy and may obviate the need for a post-mortem in some patients. However, if a post-mortem is needed, the clinical notes should always be available for the pathologists and a senior member of the patient's team should attend the post-mortem to help accurate death certification.

A giant colonic diverticulum presenting as a 'phantom mass': a case report.

INTRODUCTION: Diverticulosis coli is the most common disease of the colon in Western countries. Giant colonic diverticulum, defined as a colonic diverticulum measuring 4 cm in size or larger, represents an unusual manifestation of this common clinical entity. CASE PRESENTATION: A 68-year-old Caucasian British woman with a history of intermittent lower abdominal mass, leg swelling and focal neurological symptoms underwent extensive non-diagnostic investigations over a significant period under a number of disciplines. The reason for a diagnosis being elusive in part related to the fact that the mass was never found on clinical and ultrasound examination. As a result, the patient's validity was questioned. Ultimately, this 'phantom-mass' was diagnosed as a giant colonic diverticulum causing intermittent compression of the iliac vein and obturator nerve. CONCLUSION: Intermittent compression of the iliac vein and the obturator nerve by a colonic diverticulum has not previously been reported. A giant colonic diverticulum presenting as an intermittent mass is very rare. This case also illustrates two factors. First, the patient is often right. Second, the optimal mode of investigation for any proven or described abdominal mass with referred symptoms is cross-sectional imaging, typically a computed tomography scan, irrespective whether the mass or symptoms are constant or intermittent.

Whose appendicectomy?--Do laparoscopic appendicectomies impair SHO training?

INTRODUCTION: Open appendicectomy is an ideal procedure for junior surgical trainees to develop operative skills. However, in recent years, we have noticed a decline in the number of appendicectomies performed by basic surgical trainees and a shift towards increasing use of laparoscopic appendicectomy. The aim of this study was to determine whether the growing popularity of laparoscopic appendicectomy is having a detrimental impact on the training experience of SHOs. PATIENTS AND METHODS: We undertook a retrospective review of all cases of appendicectomies performed in one district hospital over a 7-year period (August 1999 to August 2006.) A standard performa was used to extract data from the original case notes of these patients relating to the operating surgeon and technique. RESULTS: Data were obtained for 857 appendicectomies. Between February 2002 and July 2003, there was a significant decline in the proportion of appendicectomies performed by SHOs from 78.7% to 29.3% (P < 0.001). Either side of this decline there were no significant changes in the proportion of SHO appendicectomies. The number of appendicectomies performed laparoscopically only began to rise after February 2004, with a year-on-year increase. The number of appendicectomies performed by SHOs remained stable during this time. No laparoscopic appendicectomy was performed by an SHO. CONCLUSIONS: We found no evidence that the popularisation of laparoscopic appendicectomy has contributed to the decline of appendicectomies performed by SHOs. Nevertheless, with the continual rise in popularity of this procedure, it is important to balance training opportunities for both junior and higher surgical trainees.

Aortoduodenal fistula and streptococcal myonecrosis.

Pyomyositis is a rare primary bacterial infection of the skeletal muscles. Pyomyonecrosis is the most severe manifestation of this disease and is associated with a potentially devastating outcome. Patients with peripheral vascular disease presenting with pyomyositis may be difficult to distinguish from those with critical ischemia or synthetic graft sepsis. This article reports on a patient with aortobifemoral bypass graft and severe vitamin B(12) deficiency who developed pyomyonecrosis and aortoduodenal fistula. This article highlights the etiologic dilemma, diagnostic difficulties, and management challenges inherent in such cases. Pitfalls in our management of this patient are discussed.