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1. Prophylactic biological mesh reinforcement versus standard closure of stoma site (ROCSS): a multicentre, randomised controlled trial

Author

Aneel Bhangu, Dmitri Nepogodiev, Natalie Ives, Laura Magill, James Glasbey, Colm Forde, Thue Bisgaard, Kelly Handley, Samir Mehta, Dion Morton, Thomas Pinkney, James Brown, Kaori Futaba, Sarah Khan, Arvind Pallan, Abhilasha Patel, Steve Ashdown-Phillips, Tracy Roberts, Susan Jowett, Lorraine Munetsi, Andrew Torrance, Nicholas Hilken, Matt Hill, Mark Hunter, Susan Leek, Helen Lilly, Amruta Sawant, Alexandra Vince, Michael Walters, Willem Bemelman, Marjolein Blussé, Wernard Borstlap, Olivier RC Busch, Christianne Buskens, Charlotte Klaver, Hendrik Marsman, Oddeke van Ruler, Pieter Tanis, Emma Westerduin, Dennis Wicherts, Parthasarathi Das, Sharadah Essapen, Victoria Frost, Ana Glennon, Catherine Gray, Anwar Hussain, Lisa McNichol, Pasha Nisar, Humphrey Scott, Jonathan Trickett, Prateesh Trivedi, Daniel White, Talakalukoppa Amarnath, Rohan Ardley, Robin Gupta, Emily Hall, Kathryn Hodgkins, Harjeet Narula, Terri-Ann Sewell, John M Simms, Julie Toms, Tim White, Angela Atkinson, Dan Beral, Nicola Lancaster, Felicity Mackenzie, Tim Wilson, David Cruttenden-Wood, Jackie Gibbins, Mark Halls, Dennise Hill, Karen Hogben, Stephanie Jones, Michael J Lamparelli, Mark Lewis, Sarah Moreton, Paul Ng, Arabis Oglesby, James Orbell, Benjamin Stubbs, Krishnan Subramanian, Anjay Talwar, Simon Wilsher, Mohammed Al-Rashedy, Catherine Fensom, Muhammed Gok, Lisa Hardstaff, Kamran Malik, Mohammed Sadat, Barbara Townley, Lesley Wilkinson, Tracey Cosier, Sudhakar Mangam, Mohamed Rabie, Graham Broadley, John Canny, Simon Fallis, Nikki Green, Ahmed Hawash, Sharad Karandikar, Mehboob Mirza, Edward Rawstorne, Julie Reddan, Jonathan Richardson, Chris Thompson, Kathryn Waite, Haney Youssef, Lindsey De Nes, Steffen Rosenstock, Pernille Strandfelt, Mikkel Westen, Kamal Aryal, Kirosh Shankar Kshatriya, Roshan Lal, Vamsi Velchuru, Elva Wilhelmsen, Ayesha Akbar, Anthony Antoniou, Sue Clark, Pooja Datt, Jason Goh, Ian Jenkins, Robin Kennedy, Yasuko Maeda, Piero Nastro, Harriet Owen, Robin KS Phillips, Janindra Warusavitarne, Joanne Bradley-Potts, Peter Charleston, Hamish Clouston, Sarah Duff, Taher Fatayer, Anna Gipson, Nick Heywood, Muneer Junejo, James Kennedy, Helen Lalor, Chris Manning, Richard McCormick, Kathryn Parmar, Stephen Preston, Aswatha Ramesh, Abhiram Sharma, Karen Telford, Abidemi Adeosun, Toby Hammond, Susan Smolen, Joanne Topliffe, James G Docherty, Michael Lim, Kathleen Macleod, Eimar Monaghan, Lesley Patience, Ian Thomas, Kenneth G Walker, Michael Walker, Angus JM Watson, Amanda Burgess, Yasser Ghanem, Georgina Glister, Sandeep Kapur, Abhilash Paily, Atanu Pal, Rathinam Ravikumar, Melissa Rosbergen, Kevin Sargen, Christopher Speakman, Anil K Agarwal, Amlan Banerjee, David Borowski, Dharmendra Garg, Talvinder Gill, Tracey Johnston, Susan Kelsey, Phanibhushana Chakravarthy Munipalle, Mohamed Tabaqchali, Deborah Wilson, Austin Acheson, Heather Cripps, Ahmed El-Sharkawy, Oliver Ng, Parveen Sharma, Kym Ward, Dawne Chandler, Edward Courtney, John Bunni, Katrina Butcher, Stephen Dalton, Ian Flindall, Joyce Katebe, Pratik Roy, Jeremy Tate, Tracy Vincent, Michael ER Williamson, James Wood, Mark Bignell, Graham Branagan, Jack Broardhurst, Helen Chave, Hilary Dean, Nigel D'Souza, Gemma Foster, Simon Sleight, Rupesh Sutaria, Ishmail Ahmed, Misra Rai Budhoo, Julie Colley, Neil Cruickshank, Kathryn Gill, Anne Hayes, Howard Joy, Carrington Kamabjha, James Plowright, Simon Radley, Mr Rea, Vijay Thumbe, Philip Varghese, Richard Wilkin, Elzbieta Zulueta, Lynne Allsop, Bence Atkari, Krishnamurthy Badrinath, Prita Daliya, Mukul Dube, Cheryl Heeley, Richard Hind, Dominic Nash, Andrea Palfreman, Oliver Peacock, Nicholas Watson, Michelle Blodwell, Ali Javaid, Ashiq Mohamad, Karim Muhammad, Nafees Qureshi, Stephanie Ridgway, Kamran Siddiqui, Mamoon Solkar, Joanne Vere, Alexander Wordie, Jessica Chang, Sanaa Elgaddal, Marie Green, Marianne Hollyman, Nazzia Mirza, Jayne Rankin, Graham Williams, Wadah Ali, Anne Hardwick, Zakir Mohamed, Ahmad Navid, Kimberley Netherton, Mugurel Obreja, Milind Rao, Joanna Stringer, Athula Tennakoon, Timothy Bullen, Mansoor Butt, Robin Dawson, Sarah Dawson, Martin Farmer, Veerabhadram Garimella, Zoe Gates, Lisa Wilkings, Neil Yeomans, Olufunso Adedeji, Rashid Alalawi, Aamed Al Araimi, Shazad Ashraf, Simon Bach, Andrew Beggs, Carmen Cagigas, Mit Dattani, Nikolletta Dimitriou, Manijeh Ghods-Ghorbani, David Gourevitch, Geoffrey Haydon, Tariq Ismail, Christopher Keh, Dion G Morton, Mandip Narewal, Trifonas Papettas, Tom Pinkney, Aaron Poh, Edward Ranstorne, Timothy J Royle, Tahir Shah, Jagdeep Singh, Chris Smart, Nigel Suggett, Muhammad Tayyab, Deepak Vijayan, Ravinder Vohra, Naseem Wairaich, Denise Yeung, Richard Bamford, Joanne Chambers, David Cotton, Rebecca Houlihan, James Kynaston, Rob Longman, Amelia Lowe, David Messenger, Anwar Owais, Catherine Phillpott, Jamshed Shabbir, Phil Baragwanath, Charlotte El-Sayed, Anne Gaunt, Chetan Khatri, Peter McCullough, Stephen Ward, Ross Obukofe, Robert Stroud, David Mason, Nigel Williams, Ling S Wong, Sanjay Chaudhri, Jill Cooke, Melissa Cunha, Howard Fairey, Michael Norwood, Baljit Singh, Sarah Thomasset, Sian Abbott, Sarah Addison, James Archer, Robert Church, Erika Holford, Fionnaula Lenehan, Steve Odogwu, Lisa Richardson, Jane Sidebotham, Elaine Swan, Alison Tilley, Lynda Wagstaff, Isobel Amey, Yolanda Baird, Neil Cripps, Susanna Greenslade, Guy Harris, Bruce Levy, Paul Mckenzie, Alison Misselbrook, Sally Moore, Angela Skull, Deborah Nicol, Bala Reddy, Jessica Thrush, Miriam Iglesias Vecchio, Yvonne Dunn, Claire Williams, Sanjay Furtado, Michael Gill, Lydia Gilmore, Paul Goldsmith, Cezary Kocialkowski, Sadasivam Loganathan, Rabindra Nath, Marius Paraoan, Tracey Taylor, Andrew Allison, Joanna Allison, Nathan Curtis, Richard Dalton, Conrad D'Costa, Godwin Dennison, Jake Foster, Nader Francis, James Gibbons, Mohammed Hamdan, Alison Lewis, Jonathan Ockrim, Rishabha Sharma, Katie Spurdle, Saseendran Varadharajan, Assad Aghahoseini, David J Alexander, Dibyendu Bandyopadhyay, Ian Bradford, Praminthra Chitsabesan, Zoe Coleman, Andrew Gibson, Kostas Lasithiotakis, Dimitrios Panagiotou, Konstantinos Polyzois, Stevan Stojkovic, Nicholas Woodcock, Monica Wright, Rachel Hargest, Richard Jackson, Arumugam Rajesh, Olagunju Ogunbiyi, Andrew Slater, Ly-Mee Yu, Surgery, AGEM - Digestive immunity, AGEM - Re-generation and cancer of the digestive system, AGEM - Endocrinology, metabolism and nutrition, and Graduate School

Subjects
Adult, Male, medicine.medical_specialty, Hernia, Incisional hernia, Colon, medicine.medical_treatment, 030204 cardiovascular system & hematology, Article, law.invention, Abdominal wall, 03 medical and health sciences, Ileostomy, 0302 clinical medicine, Ileus, Postoperative Complications, Randomized controlled trial, Double-Blind Method, law, General & Internal Medicine, medicine, Incisional Hernia, Humans, 030212 general & internal medicine, Prospective Studies, 11 Medical and Health Sciences, Aged, Intention-to-treat analysis, business.industry, Incidence (epidemiology), Surgical Stomas, Abdominal Wound Closure Techniques, General Medicine, Prostheses and Implants, Middle Aged, Surgical Mesh, medicine.disease, 3. Good health, Surgery, medicine.anatomical_structure, Relative risk, Female, Collagen, business, Reinforcement of Closure of Stoma Site (ROCSS) Collaborative and West Midlands Research Collaborative
Abstract

Summary Background Closure of an abdominal stoma, a common elective operation, is associated with frequent complications; one of the commonest and impactful is incisional hernia formation. We aimed to investigate whether biological mesh (collagen tissue matrix) can safely reduce the incidence of incisional hernias at the stoma closure site. Methods In this randomised controlled trial (ROCSS) done in 37 hospitals across three European countries (35 UK, one Denmark, one Netherlands), patients aged 18 years or older undergoing elective ileostomy or colostomy closure were randomly assigned using a computer-based algorithm in a 1:1 ratio to either biological mesh reinforcement or closure with sutures alone (control). Training in the novel technique was standardised across hospitals. Patients and outcome assessors were masked to treatment allocation. The primary outcome measure was occurrence of clinically detectable hernia 2 years after randomisation (intention to treat). A sample size of 790 patients was required to identify a 40% reduction (25% to 15%), with 90% power (15% drop-out rate). This study is registered with ClinicalTrials.gov, NCT02238964. Findings Between Nov 28, 2012, and Nov 11, 2015, of 1286 screened patients, 790 were randomly assigned. 394 (50%) patients were randomly assigned to mesh closure and 396 (50%) to standard closure. In the mesh group, 373 (95%) of 394 patients successfully received mesh and in the control group, three patients received mesh. The clinically detectable hernia rate, the primary outcome, at 2 years was 12% (39 of 323) in the mesh group and 20% (64 of 327) in the control group (adjusted relative risk [RR] 0·62, 95% CI 0·43–0·90; p=0·012). In 455 patients for whom 1 year postoperative CT scans were available, there was a lower radiologically defined hernia rate in mesh versus control groups (20 [9%] of 229 vs 47 [21%] of 226, adjusted RR 0·42, 95% CI 0·26–0·69; p

Published
2019

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

Author

Mohammed Hamdan, Elizabeth Armstrong, William Seligman, Natalie S Blencowe, Tonia Munder, Tim Draycott, Rhiannon C Macefield, Benjamin R Waterhouse, Rachael Gooberman-Hill, Jonathan Mathers, Melanie Calvert, Robert J Longman, Katarzyna Bera, Joanna Coast, Sean Strong, Matthew Mason, O. Brown, David Cotton, James Glasbey, Stephen O'Brien, Dimitrios Siassakos, Vijay Korwar, Tom Milne, Jo C Dumville, Christel McMullan, Kathryn Lee, Morwena Marshall, Madeleine Clout, A. Torrance, Dmitri Nepogodiev, George Hill, Jenny L Donovan, Lazaros Andronis, Jessica Lloyd, Thomas Pinkney, Khaldoun Nadi, Jamie O’Callaghan, Caroline Pope, Daniel Hughes, Danya Bakhbakhi, Jane M Blazeby, Chris A Rogers, Anwar Owais, Hannah Gould Brown, Mark Woodward, Richard Bamford, Barnaby C Reeves, Jeffrey Lim, Nicky J Welton, Lucy Ellis, David E. Messenger, Piriyankan Ananthavarathan, Lloyd Rickard, Charlotte E Murkin, Richard Lovegrove, Muhammad Atif, Benjamin E Byrne, Anne Pullyblank, Joanne Bennett, Rosie A Harris, Samir Pathak, Daisy Elliott, Kate Ashton, Caroline Fryer, and Leila Rooshenas

Subjects
Male, SURGERY, medicine.medical_treatment, Cost-Benefit Analysis, Psychological intervention, Validity, Pilot Projects, Feasibility study, law.invention, surgery, 0302 clinical medicine, Randomized controlled trial, law, Surveys and Questionnaires, Abdomen, 030212 general & internal medicine, Health Policy, FEASIBILITY STUDY, Surgical wound, Middle Aged, lcsh:R855-855.5, Centre for Surgical Research, Surgical Procedures, Operative, pilot randomised controlled trial, Female, Quality-Adjusted Life Years, Research Article, Adult, medicine.medical_specialty, lcsh:Medical technology, BTC (Bristol Trials Centre), 03 medical and health sciences, Cronbach's alpha, Patient experience, medicine, Humans, Surgical Wound Infection, SURGICAL SITE INFECTION, Caesarean section, Aged, WOUND DRESSINGS, business.industry, Cesarean Section, Reproducibility of Results, QUALITATIVE RESEARCH, surgical site infection, Bandages, PILOT RANDOMISED CONTROLLED TRIAL, value of information, VALUE OF INFORMATION, Physical therapy, Feasibility Studies, business, 030217 neurology & neurosurgery, RD, qualitative research, Abdominal surgery, wound dressings
Abstract

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).

Published
2019
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3. Validation of the Bluebelle Wound Healing Questionnaire for assessment of surgical-site infection in closed primary wounds after hospital discharge

Author

Natalie S Blencowe, Dmitri Nepogodiev, Jessica Lloyd, Thomas Pinkney, Barnaby C Reeves, O. Brown, Sean Strong, Matthew Mason, Dimitrios Siassakos, Tom Milne, Hannah Gould Brown, Elizabeth Armstrong, Stephen O'Brien, Rhiannon C Macefield, Kerry N L Avery, Tim Draycott, Mark Woodward, A. Torrance, Danya Bakhbakhi, Daisy Elliott, George Hill, Robert J Longman, Richard Bamfor, Piriyankan Ananthavarathan, Daniel Hughes, Lloyd Rickard, Sara T Brookes, Richard Lovegrove, Nicky J Welton, Benjamin R. Waterhouse, Lazaros Andronis, Jane M Blazeby, Charlotte E Murkin, David Cotton, Joanna Coast, David E. Messenger, Katarzyna Bera, Benjamin E Byrne, Christel McMullan, Morwena Marshall, Muhammad Atif, James Glasbey, Caroline Pope, Lucy Ellis, Kathryn Lee, Anwar Owais, Jo C Dumville, Joanne Bennett, Samir Pathak, Rosie A Harris, Jenny L Donovan, Kate Ashton, William Seligman, Caroline Fryer, Leila Rooshenas, Khaldoun Nadi, Jamie O’Callaghan, Mohammed Hamdan, Chris A Rogers, Simon Davey, Anne Pullyblank, Vijay Korwar, Madeleine Clout, Rachael Gooberman-Hill, Jeffrey Lim, Tonia Munder, Jonathan Mathers, and Melanie Calvert

Subjects
Male, Self-assessment, medicine.medical_specialty, Observer (quantum physics), Operative Time, 030230 surgery, BTC (Bristol Trials Centre), Diagnostic Self Evaluation, 03 medical and health sciences, 0302 clinical medicine, Cronbach's alpha, Surveys and Questionnaires, Hospital discharge, Humans, Surgical Wound Infection, Medicine, Reliability (statistics), Observer Variation, Wound Healing, Receiver operating characteristic, business.industry, Reproducibility of Results, Original Articles, Middle Aged, Patient Discharge, 3. Good health, ROC Curve, Centre for Surgical Research, Physical therapy, Female, Original Article, Surgery, business, Surgical site infection, Abdominal surgery
Abstract

Background Accurate assessment of surgical‐site infection (SSI) is crucial for surveillance and research. Self‐reporting patient measures are needed because current SSI tools are limited for assessing patients after leaving hospital. The Bluebelle Wound Healing Questionnaire (WHQ) was developed for patient or observer completion; this study tested its acceptability, scale structure, reliability and validity in patients with closed primary wounds after abdominal surgery. Methods Patients completed the WHQ (self‐assessment) within 30 days after leaving hospital and returned it by post. Healthcare professionals completed the WHQ (observer assessment) by telephone or face‐to‐face. Questionnaire response rates and patient acceptability were assessed. Factor analysis and Cronbach's α examined scale structure and internal consistency. Test–retest and self‐ versus observer reliability assessments were performed. Sensitivity and specificity for SSI discrimination against a face‐to‐face reference diagnosis (using Centers for Disease Control and Prevention criteria) were examined. Results Some 561 of 792 self‐assessments (70·8 per cent) and 597 of 791 observer assessments (75·5 per cent) were completed, with few missing data or problems reported. Data supported a single‐scale structure with strong internal consistency (α greater than 0·8). Reliability between test–retest and self‐ versus observer assessments was good (κ 0·6 or above for the majority of items). Sensitivity and specificity for SSI discrimination was high (area under the receiver operating characteristic (ROC) curve 0·91). Conclusion The Bluebelle WHQ is acceptable, reliable and valid with a single‐scale structure for postdischarge patient or observer assessment of SSI in closed primary wounds., Simple and valid

Published
2019
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