Protocol for Surgery or Cast of the EpicoNdyle in Children's Elbows (SCIENCE).

Aims: The management of fractures of the medial epicondyle is one of the greatest controversies in paediatric fracture care, with uncertainty concerning the need for surgery. The British Society of Children's Orthopaedic Surgery prioritized this as their most important research question in paediatric trauma. This is the protocol for a randomized controlled, multicentre, prospective superiority trial of operative fixation versus nonoperative treatment for displaced medial epicondyle fractures: the Surgery or Cast of the EpicoNdyle in Children's Elbows (SCIENCE) trial. Methods: Children aged seven to 15 years old inclusive, who have sustained a displaced fracture of the medial epicondyle, are eligible to take part. Baseline function using the Patient-Reported Outcomes Measurement Information System (PROMIS) upper limb score, pain measured using the Wong Baker FACES pain scale, and quality of life (QoL) assessed with the EuroQol five-dimension questionnaire for younger patients (EQ-5D-Y) will be collected. Each patient will be randomly allocated (1:1, stratified using a minimization algorithm by centre and initial elbow dislocation status (i.e. dislocated or not-dislocated at presentation to the emergency department)) to either a regimen of the operative fixation or non-surgical treatment. Outcomes: At six weeks, and three, six, and 12 months, data on function, pain, sports/music participation, QoL, immobilization, and analgesia will be collected. These will also be repeated annually until the child reaches the age of 16 years. Four weeks after injury, the main outcomes plus data on complications, resource use, and school absence will be collected. The primary outcome is the PROMIS upper limb score at 12 months post-randomization. All data will be obtained through electronic questionnaires completed by the participants and/or parents/guardians. The NHS number of participants will be stored to enable future data linkage to sources of routinely collected data (i.e. Hospital Episode Statistics).

Offer of a bandage versus rigid immobilisation in 4- to 15-year-olds with distal radius torus fractures: the FORCE equivalence RCT.

BACKGROUND: Torus (buckle) fractures of the wrist are the most common fractures in children involving the distal radius and/or ulna. It is unclear if children require rigid immobilisation and follow-up or would recover equally as well by being discharged without any immobilisation or a bandage. Given the large number of these injuries, identifying the optimal treatment strategy could have important effects on the child, the number of days of school absence and NHS costs. OBJECTIVES: To establish whether or not treating children with a distal radius torus fracture with the offer of a soft bandage and immediate discharge (i.e. offer of a bandage) provides the same recovery, in terms of pain, function, complications, acceptability, school absence and resource use, as treatment with rigid immobilisation and follow-up as per usual practice (i.e. rigid immobilisation). DESIGN: A pragmatic, multicentre, randomised controlled equivalence trial. SETTING: Twenty-three UK emergency departments. PARTICIPANTS: A total of 965 children (aged 4-15 years) with a distal radius torus fracture were randomised from January 2019 to July 2020 using a secure, centralised, online-encrypted randomisation service. Exclusion criteria included presentation > 36 hours after injury, multiple injuries and an inability to complete follow-up. INTERVENTIONS: A bandage was offered to 489 participants and applied to 458, and rigid immobilisation was carried out in 476 participants. Participants and clinicians were not blinded to the treatment allocation. MAIN OUTCOME MEASURES: The pain at 3 days post randomisation was measured using the Wong-Baker FACES Pain Rating Scale. Secondary outcomes were the patient-reported outcomes measurement system upper extremity limb score for children, health-related quality of life, complications, school absence, analgesia use and resource use collected up to 6 weeks post randomisation. RESULTS: A total of 94% of participants provided primary outcome data. At 3 days, the primary outcome of pain was equivalent in both groups. With reference to the prespecified equivalence margin of 1.0, the adjusted difference in the intention-to-treat population was -0.10 (95% confidence interval -0.37 to 0.17) and the per-protocol population was -0.06 (95% confidence interval -0.34 to 0.21). There was equivalence of pain in both age subgroups (i.e. 4-7 years and 8-15 years). There was no difference in the rate of complications, with five complications (1.0%) in the offer of a bandage group and three complications (0.6%) in the rigid immobilisation group. There were no differences between treatment groups in functional recovery, quality of life or school absence at any point during the follow-up. Analgesia use was marginally higher at day 1 in the offer of a bandage group than it was in the rigid immobilisation group (83% vs. 78% of participants), but there was no difference at other time points. The offer of a bandage significantly reduced the cost of treatment and had a high probability of cost-effectiveness at a willingness-to-pay threshold of £30,000 per quality-adjusted life-year. LIMITATIONS: Families had a strong pre-existing preference for the rigid immobilisation treatment. Given this, and the inability to blind families to the treatment allocation, observer bias was a concern. However, there was clear evidence of equivalence. CONCLUSIONS: The study findings support the offer of a bandage in children with a distal radius torus fracture. FUTURE WORK: A clinical decision tool to determine which children require radiography is an important next step to prevent overtreatment of minor wrist fractures. There is also a need to rationalise interventions for other common childhood injuries (e.g. 'toddler's fractures' of the tibia). TRIAL REGISTRATION: This trial is registered as ISRCTN13955395 and UKCRN Portfolio 39678. FUNDING: This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 26, No. 33. See the NIHR Journals Library website for further project information.

BACKGROUND: Torus fractures (also called buckle fractures) of the wrist are the most common type of broken bone in children, affecting 60,000 children in the UK per year. They are the mildest form of broken bone, in which the bone crushes (or buckles). Despite these fractures being so common, there is no 'standard treatment'. The traditional treatment is to use a plaster cast and arrange outpatient follow-up. Recent medical research has suggested that wearing a bandage, or even having no treatment, might result in similar healing. In this study, we looked into whether or not a bandage (which was optional to wear) and no further follow-up resulted in the same recovery as a hard splint and usual follow-up. A total of 965 children aged 4­15 years from 23 emergency departments in the UK took part in the study. Children were evenly divided between the bandage and hard splint groups in a process called randomisation. Prior to the study, families told us that managing pain after injury was the most important issue to them. We asked children and their families to tell us about pain, recovery using the arm, quality of life, complications encountered and school absences. We also looked at the financial costs to families and the NHS. WHAT DID THE TRIAL FIND?: The two treatments resulted in the same outcomes. The majority of those offered a bandage chose to wear it immediately. There was no difference at all in the levels of pain between those treated with a hard splint and usual outpatient follow-up and those offered a bandage and discharge (i.e. no further follow up) from hospital the same day. Similarly, there was no difference in the recovery using the arm, quality of life, complications encountered or school absences. There was a very slight increase in pain killer use in the bandage group at day 1, but not at any other time point. Overall, the cost of the offer of a bandage was slightly lower for families and the NHS. In conclusion, the findings of this study support offering a bandage to be used at the discretion of families to treat children with a torus fracture of the wrist.

Does digital, multimedia information increase recruitment and retention in a children's wrist fracture treatment trial, and what do people think of it? A randomised controlled Study Within A Trial (SWAT).

OBJECTIVES: To evaluate digital, multimedia information (MMI) for its effects on trial recruitment, retention, decisions about participation and acceptability by patients, compared with printed information. DESIGN: Study Within A Trial using random cluster allocation within the Forearm Fracture Recovery in Children Evaluation (FORCE) study. SETTING: Emergency departments in 23 UK hospitals. PARTICIPANTS: 1409 children aged 4-16 years attending with a torus (buckle) fracture, and their parents/guardian. Children's mean age was 9.2 years, 41.0% were female, 77.4% were ethnically White and 90.0% spoke English as a first language. INTERVENTIONS: Participants and their parents/guardian received trial information either via multimedia, including animated videos, talking head videos and text (revised for readability and age appropriateness when needed) on tablet computer (MMI group; n=681), or printed participant information sheet (PIS group; n=728). OUTCOME MEASURES: Primary outcome was recruitment rate to FORCE. Secondary outcomes were Decision-Making Questionnaire (nine Likert items, analysed summatively and individually), three 'free text' questions (deriving subjective evaluations) and trial retention. RESULTS: MMI produced a small, not statistically significant increase in recruitment: 475 (69.8%) participants were recruited from the MMI group; 484 (66.5%) from the PIS group (OR=1.35; 95% CI 0.76 to 2.40, p=0.31). A total of 324 (23.0%) questionnaires were returned and analysed. There was no difference in total Decision-Making Questionnaire scores: adjusted mean difference 0.05 (95% CI -1.23 to 1.32, p=0.94). The MMI group was more likely to report the information 'very easy' to understand (89; 57.8% vs 67; 39.4%; Z=2.60, p=0.01) and identify information that was explained well (96; 62.3% vs 71; 41.8%). Almost all FORCE recruits were retained at the 6 weeks' timepoint and there was no difference in retention rate between the information groups: MMI (473; 99.6%); PIS (481; 99.4%). CONCLUSIONS: MMI did not increase recruitment or retention in the FORCE trial, but participants rated multimedia as easier to understand and were more likely to evaluate it positively. TRIAL REGISTRATION NUMBER: ISRCTN73136092 and ISRCTN13955395.

Negative-pressure wound therapy compared with standard dressings following surgical treatment of major trauma to the lower limb: the WHiST RCT.

BACKGROUND: Major trauma is the leading cause of death in people aged < 45 years. Patients with major trauma usually have lower-limb fractures. Surgery to fix the fractures is complicated and the risk of infection may be as high as 27%. The type of dressing applied after surgery could potentially reduce the risk of infection. OBJECTIVES: To assess the deep surgical site infection rate, disability, quality of life, patient assessment of the surgical scar and resource use in patients with surgical incisions associated with fractures following major trauma to the lower limbs treated with incisional negative-pressure wound therapy versus standard dressings. DESIGN: A pragmatic, multicentre, randomised controlled trial. SETTING: Twenty-four specialist trauma hospitals representing the UK Major Trauma Network. PARTICIPANTS: A total of 1548 adult patients were randomised from September 2016 to April 2018. Exclusion criteria included presentation > 72 hours after injury and inability to complete questionnaires. INTERVENTIONS: Incisional negative-pressure wound therapy (n = 785), in which a non-adherent absorbent dressing covered with a semipermeable membrane is connected to a pump to create a partial vacuum over the wound, versus standard dressings not involving negative pressure (n = 763). Trial participants and the treating surgeon could not be blinded to treatment allocation. MAIN OUTCOME MEASURES: Deep surgical site infection at 30 days was the primary outcome measure. Secondary outcomes were deep infection at 90 days, the results of the Disability Rating Index, health-related quality of life, the results of the Patient and Observer Scar Assessment Scale and resource use collected at 3 and 6 months post surgery. RESULTS: A total of 98% of participants provided primary outcome data. There was no evidence of a difference in the rate of deep surgical site infection at 30 days. The infection rate was 6.7% (50/749) in the standard dressing group and 5.8% (45/770) in the incisional negative-pressure wound therapy group (intention-to-treat odds ratio 0.87; 95% confidence interval 0.57 to 1.33; p = 0.52). There was no difference in the deep surgical site infection rate at 90 days: 13.2% in the standard dressing group and 11.4% in the incisional negative-pressure wound therapy group (odds ratio 0.84, 95% confidence interval 0.59 to 1.19; p = 0.32). There was no difference between the two groups in disability, quality of life or scar appearance at 3 or 6 months. Incisional negative-pressure wound therapy did not reduce the cost of treatment and was associated with a low probability of cost-effectiveness. LIMITATIONS: Owing to the emergency nature of the surgery, we anticipated that some patients who were randomised would subsequently be unable or unwilling to participate. However, the majority of the patients (85%) agreed to participate. Therefore, participants were representative of the population with lower-limb fractures associated with major trauma. CONCLUSIONS: The findings of this study do not support the use of negative-pressure wound therapy in patients having surgery for major trauma to the lower limbs. FUTURE WORK: Our work suggests that the use of incisional negative-pressure wound therapy dressings in other at-risk surgical wounds requires further investigation. Future research may also investigate different approaches to reduce postoperative infections, for example the use of topical antibiotic preparations in surgical wounds and the role of orthopaedic implants with antimicrobial coatings when fixing the associated fracture. TRIAL REGISTRATION: Current Controlled Trials ISRCTN12702354 and UK Clinical Research Network Portfolio ID20416. FUNDING: This project was funded by the National Institute for Health Research Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 38. See the NIHR Journals Library for further project information.

WHAT DID THE TRIAL FIND?: We found no evidence of a difference in the rate of surgical site infection between those patients randomised to negative-pressure wound therapy and those patients randomised to standard wound dressings. There was no difference in the rate of other wound healing complications or in the patients' self-report of disability, health-related quality of life or scar healing. Negative-pressure wound therapy is very unlikely to be cost-effective for the NHS. In conclusion, and contrary to previous reports, the findings of this study do not support the use of negative-pressure wound therapy in patients having surgery for major trauma to their legs.

Major trauma is the leading cause of death worldwide in people aged < 45 years and a significant cause of short- and long-term health problems. In 85% of major trauma patients, the injury involves broken bones. Surgery to fix broken bones in the lower limbs is complicated and has risks, one of the main ones being wound infection. In these patients, rates of wound infection have been reported to be as high as 27%. One factor that may affect the risk of infection is the type of dressing applied after surgery. In this trial, we compared standard wound dressings with a new treatment called incisional negative-pressure wound therapy. Negative-pressure wound therapy is a special type of dressing whereby gentle suction is applied to the surface of the wound. A total of 1548 patients from 24 specialist trauma hospitals in the UK agreed to take part and were assigned at random to receive either a standard wound dressing or negative-pressure wound therapy after their surgery. We reviewed the recovery of the patients for 6 months. We recorded how many had an infection in the surgical wound and asked the patients to rate the extent of their disability, their quality of life and the scar healing. We also collected information about the cost of treatment.

Wound Healing In Surgery for Trauma (WHIST): statistical analysis plan for a randomised controlled trial comparing standard wound management with negative pressure wound therapy.

BACKGROUND: In the context of major trauma, the rate of wound infection in surgical incisions created during fracture fixation amongst patients with closed high-energy injuries is high. One of the factors which may reduce the risk of surgical site infection is the type of dressing applied over the closed incision. The WHIST trial evaluates the effects of negative-pressure wound therapy (NPWT) compared with standard dressings. METHODS/DESIGN: The WHIST trial is a multicentre, parallel group, randomised controlled trial. The primary outcome is the rate of deep surgical site infection at 30 days after major trauma. Secondary outcomes are measured at 3 and 6 months post-randomisation and include the Disability Rating Index, the EuroQoL EQ-5D-5 L, the Doleur Neuropathique Questionnaire, a patient-reported scar assessment, and record of complications. The analysis approaches for the primary and secondary outcomes are described here, as are the descriptive statistics which will be reported. The full WHIST protocol has already been published. DISCUSSION: This paper provides details of the planned statistical analyses for this trial and will reduce the risks of outcome reporting bias and data driven results. TRIAL REGISTRATION: International Standard Randomised Controlled Trials database, ISRCTN12702354 . Registered on 9 December 2015.

Standard wound management versus negative-pressure wound therapy in the treatment of adult patients having surgical incisions for major trauma to the lower limb-a two-arm parallel group superiority randomised controlled trial: protocol for Wound Healing in Surgery for Trauma (WHIST).

INTRODUCTION: Patients with closed high-energy injuries associated with major trauma have surprisingly high rates of surgical site infection in incisions created during fracture fixation. One factor that may reduce the risk of surgical site infection is the type of dressing applied over the closed surgical incision. In this multicentre randomised clinical trial, negative-pressure wound therapy will be compared with standard dressings with outcomes of deep infection, quality of life, pain and disability. METHODS AND ANALYSIS: Adult patients presenting to hospital within 72 hours of sustaining major trauma, requiring a surgical incision to treat a fractured lower limb, are eligible for inclusion. Randomisation, stratified by trial centre, open/closed fracture at presentation and Injury Severity Score (ISS) ≤15 versus ISS ≥16 will be administered via a secure web-based service using minimisation. The random allocation will be to either standard wound management or negative-pressure wound therapy.Trial participants will usually have clinical follow-up at the local fracture clinic for a minimum of 6 months, as per standard National Health Service practice. Diagnosis of deep infection will be recorded at 30 days. Functional, pain and quality of life outcome data will be collected using the Disability Rating Index, Douleur Neuropathique Questionnaire and Euroqol - 5 Dimension - 5 level (EQ-5D-5L) questionnaires at 3 months and 6 months postinjury. Further data will be captured on resource use and any late postoperative complications.Longer term outcomes will be assessed annually for 5 years and reported separately. ETHICS AND DISSEMINATION: National Research Ethics Committee approved this study on 16 February 2016 16/WM/0006.The National Institute for Health Research Health Technology Assessment monograph and a manuscript to a peer-reviewed journal will be submitted on completion of this trial. The results of this trial will inform clinical practice on the clinical and cost-effectiveness of the treatment of this injury. TRIAL REGISTRATION NUMBER: ISRCTN12702354; Pre-results.

Hypoxia of sleep apnoea: cardiopulmonary and cerebral changes after intermittent hypoxia in rats.

Sleep apnoea (SA) is common, especially in elderly people. In severe cases, arterial P(O2) may be lowered for a third or more in a night of sleep. To simulate the degree and duration of severe SA we exposed rats in a normobaric environmental chamber to 10% O(2) for 4h daily for 56 days (intermittent hypoxia: IH group) and compared them with rats continuously exposed for 8 weeks (continuous hypoxia: CH group) and control rats breathing room air (normoxic: N group). We found significant cardiopulmonary and cerebral changes. Right ventricular hypertrophy developed in IH and to a greater extent in CH. Small peripheral lung vessels developed thicker walls (assessed by a new method), which reduced their lumen, more in CH than IH. Coronal brain sections were immunostained for the glucose-transporter 1 (GLUT1) and the vascular endothelial growth factor (VEGF). The percentages of immunoreactivity in the frontal and temporal cortex, hippocampus, accumbens and putamen were determined by image-capture analysis. We noted GLUT1 immunoreactivity of the capillaries was similarly increased in all regions after CH but less so after IH. However, there was a significant linear trend in GLUT1 reactivity from N to IH to CH (R(2) = 0.73, P = 0.007) that was also confirmed by analysis of variance. The extent of VEGF-stained neurones and glial cells was significantly increased in all regions after IH but not after CH. This suggests that the signals for angiogenesis were complete or arrested after CH. Our findings have implications for the elderly subjected to hypoxic episodes during sleep apnoea.