Study protocol for a cluster randomised trial of sterile glove and instrument change at the time of wound closure to reduce surgical site infection in low- and middle-income countries (CHEETAH)

NIHR Global Health Research Unit on Global Surgery, Adesoji O Ademuyiwa, Adewale O Adisa, Aneel Bhangu, Peter Brocklehurst, Sohini Chakrabortee, Dhruva Ghosh, James Glasbey, Parvez D Haque, Pollyanna Hardy, Ewen Harrison, Jc Allen Ingabire, Lawani Ismail, Bryar Kadir, Rachel Lillywhite, Laura Magill, Antonio Ramos de la Medina, Rachel Moore, Mark Monahan, Dion Morton, Dmitri Nepogodiev, Faustin Ntirenganya, Omar Omar, Thomas Pinkney, Donna Smith, Stephen Tabiri, Neil Winkles, NIHR Global Health Research Unit on Global Surgery, Adesoji O Ademuyiwa, Adewale O Adisa, Aneel Bhangu, Peter Brocklehurst, Sohini Chakrabortee, Dhruva Ghosh, James Glasbey, Parvez D Haque, Pollyanna Hardy, Ewen Harrison, Jc Allen Ingabire, Lawani Ismail, Bryar Kadir, Rachel Lillywhite, Laura Magill, Antonio Ramos de la Medina, Rachel Moore, Mark Monahan, Dion Morton, Dmitri Nepogodiev, Faustin Ntirenganya, Omar Omar, Thomas Pinkney, Donna Smith, Stephen Tabiri, Neil Winkles

Abstract

Background: Surgical site infection (SSI) represents a major burden for patients, doctors, and health systems around the world. The aim of this trial is to assess whether the practice of using separate sterile gloves and instruments to close wounds at the end of surgery compared to current routine hospital practice can reduce surgical site infection at 30-days post-surgery for patients undergoing clean-contaminated, contaminated, or dirty abdominal surgery.

Methods: This study protocol describes a pragmatic, international, multi-centre, 2-arm, cluster randomised controlled trial, with an internal pilot. Clusters are defined as hospitals within low- and middle-income countries (LMICs) defined by the Development Assistance Committee (DAC) Official Development Assistance (ODA) list, where there are at least 4 eligible hospitals per country. Hospitals (clusters) must be in LMICs where glove and instrument change are not currently routine practice. Patients (adults and children) undergoing emergency or elective abdominal surgery for a clean-contaminated, contaminated, or dirty operation are eligible for inclusion. Before closing the abdominal wall, surgeons and the scrub nurse will change gloves and use separate, sterile instruments (intervention), versus no changing gloves or using separate, sterile instruments (standard practice, control). The primary outcome is SSI within 30 days after surgery, using the Centre for Disease Control (CDC) criteria. Secondary outcomes are SSI before point of hospital discharge, and readmission, reoperation, length of hospital stay, return to normal activities, and death up to 30-days after surgery. A 12-month internal pilot, including 12 clusters and approximately 600 participants, aims to assess adherence to allocation and follow-up of patients. The main trial is powered to detect a minimum reduction in the primary outcome from 16 to 12%. A total of 12,800 participants will be recruited from 64 clusters (hospitals) each including at least 200 participants.

Discussion: Change of gloves and sterile instruments prior to fascial closure in abdominal surgery is a low-cost, simple, intraoperative intervention which involves all members of the surgical and scrub team. If effective at reducing SSI, this practice could be readily implemented across all contexts. The findings of this trial will inform future guideline updates from international healthcare organisations, including the World Health Organization.

Trial registration: ClinicalTrials.gov NCT03980652. Registered on 9 July 2019.

Keywords: Abdominal surgery; Cluster randomised trial; Gastrointestinal surgery; Infection control; Sterile gloves and instruments; Study protocol; Surgical site infection.

Conflict of interest statement

The authors declare that they have no competing interests.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
Trial schema
Fig. 2
Fig. 2
CHEETAH patient inclusion pathway

References

    1. Allegranzi B, Bagheri Nejad S, Combescure C, Graafmans W, Attar H, Donaldson L, et al. Burden of endemic health-care-associated infection in developing countries: systematic review and meta-analysis. Lancet. 2011;377(9761):228–241. doi: 10.1016/S0140-6736(10)61458-4.
    1. Horan TC, Andrus M, Dudeck MA. CDC/NHSN surveillance definition of health care-associated infection and criteria for specific types of infections in the acute care setting. Am J Infect Control. 2008;36(5):309–332. doi: 10.1016/j.ajic.2008.03.002.
    1. Astagneau P, Rioux C, Golliot F, Brucker G. Morbidity and mortality associated with surgical site infections: results from the 1997-1999 INCISO surveillance. J Hosp Infect. 2001;48(4):267–274. doi: 10.1053/jhin.2001.1003.
    1. Pinkney TD, Calvert M, Bartlett DC, Gheorghe A, Redman V, Dowswell G, Hawkins W, Mak T, Youssef H, Richardson C, Hornby S, Magill L, Haslop R, Wilson S, Morton D, West Midlands Research Collaborative. ROSSINI Trial Investigators Impact of wound edge protection devices on surgical site infection after laparotomy: multicentre randomised controlled trial (ROSSINI Trial) Bmj. 2013;347(jul31 2):f4305. doi: 10.1136/bmj.f4305.
    1. Andersson AE, Bergh I, Karlsson J, Nilsson K. Patients’ experiences of acquiring a deep surgical site infection: an interview study. Am J Infect Control. 2010;38(9):711–717. doi: 10.1016/j.ajic.2010.03.017.
    1. Leaper DJ, van Goor H, Reilly J. Surgical site infection—a European perspective of incidence and economic burden. Int Wound J. 2004;1(4):247–273. doi: 10.1111/j.1742-4801.2004.00067.x.
    1. GlobalSurg C. Surgical site infection after gastrointestinal surgery in high-income, middle-income, and low-income countries: a prospective, international, multicentre cohort study. Lancet Infect Dis. 2018;18(5):516–525. doi: 10.1016/S1473-3099(18)30101-4.
    1. GlobalSurg C. Determining the worldwide epidemiology of surgical site infections after gastrointestinal resection surgery: protocol for a multicentre, international, prospective cohort study (GlobalSurg 2) BMJ Open. 2017;7(7):e012150. doi: 10.1136/bmjopen-2016-012150.
    1. Meara JG, Hagander L, Leather AJM. Surgery and global health: a Lancet Commission. Lancet. 2014;383(9911):12–13. doi: 10.1016/S0140-6736(13)62345-4.
    1. Allegranzi B, Bischoff P, de Jonge S, Kubilay NZ, Zayed B, Gomes SM, Abbas M, Atema JJ, Gans S, van Rijen M, Boermeester MA, Egger M, Kluytmans J, Pittet D, Solomkin JS, WHO Guidelines Development Group New WHO recommendations on preoperative measures for surgical site infection prevention: an evidence-based global perspective. Lancet Infect Dis. 2016;16(12):e276–ee87. doi: 10.1016/S1473-3099(16)30398-X.
    1. Allegranzi B, Zayed B, Bischoff P, Kubilay NZ, de Jonge S, de Vries F, Gomes SM, Gans S, Wallert ED, Wu X, Abbas M, Boermeester MA, Dellinger EP, Egger M, Gastmeier P, Guirao X, Ren J, Pittet D, Solomkin JS, WHO Guidelines Development Group New WHO recommendations on intraoperative and postoperative measures for surgical site infection prevention: an evidence-based global perspective. Lancet Infect Dis. 2016;16(12):e288–e303. doi: 10.1016/S1473-3099(16)30402-9.
    1. NIHR Global Health Research Unit on Global Surgery Prioritizing research for patients requiring surgery in low-and middle-income countries. Br J Surg. 2019;106(2):e113–ee20. doi: 10.1002/bjs.11037.
    1. Hashimoto D, Chikamoto A, Arima K, Taki K, Inoue R, Imai K, Yamashita Y, Baba H. Unused sterile instruments for closure prevent wound surgical site infection after pancreatic surgery. J Surg Res. 2016;205(1):38–42. doi: 10.1016/j.jss.2016.02.044.
    1. Ventolini G, Neiger R, McKenna D. Decreasing infectious morbidity in cesarean delivery by changing gloves. J Reprod Med. 2004;49(1):13–16. doi: 10.1097/00006254-200407000-00009.
    1. Zdanowski Z, Danielsson G, Jonung T, Norgren L, Ribbe E, Thörne J, Kamme C, Schalén C. Intraoperative contamination of synthetic vascular grafts. Effect of glove change before graft implantation. A prospective randomised study. Eur J Vasc Endovasc Surg. 2000;19(3):283–287. doi: 10.1053/ejvs.1999.1035.
    1. Berríos-Torres SI, Umscheid CA, Bratzler DW, Leas B, Stone EC, Kelz RR, Reinke CE, Morgan S, Solomkin JS, Mazuski JE, Dellinger EP, Itani KMF, Berbari EF, Segreti J, Parvizi J, Blanchard J, Allen G, Kluytmans JAJW, Donlan R, Schecter WP, for the Healthcare Infection Control Practices Advisory Committee Centers for disease control and prevention guideline for the prevention of surgical site infection, 2017. JAMA Surgery. 2017;152(8):784–791. doi: 10.1001/jamasurg.2017.0904.
    1. Chan AW, Tetzlaff JM, Gotzsche PC, Altman DG, Mann H, Berlin JA, Dickersin K, Hrobjartsson A, Schulz KF, Parulekar WR, Krleza-Jeric K, Laupacis A, Moher D. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013;346(jan08 15):e7586. doi: 10.1136/bmj.e7586.
    1. Haynes AB, Weiser TG, Berry WR, Lipsitz SR, Breizat AH, Dellinger EP, et al. A surgical safety checklist to reduce morbidity and mortality in a global population. N Engl J Med. 2009;360(5):491–499. doi: 10.1056/NEJMsa0810119.
    1. Shrime MG, Dare AJ, Alkire BC, O'Neill K, Meara JG. Catastrophic expenditure to pay for surgery worldwide: a modelling study. Lancet Glob Health. 2015;3(Suppl 2):S38–S44. doi: 10.1016/S2214-109X(15)70085-9.
    1. Gheorghe A, Moran G, Duffy H, Roberts T, Pinkney T, Calvert M. Health utility values associated with surgical site infection: a systematic review. Value Health. 2015;18(8):1126–1137. doi: 10.1016/j.jval.2015.08.004.
    1. NIHR Global Health Research Unit on Global Surgery Reducing surgical site infections in low-income and middle-income countries (FALCON): a pragmatic, multicentre, stratified, randomised controlled trial. Lancet. 2021;398(10312):1687–1699. doi: 10.1016/S0140-6736(21)01548-8.
    1. Collaborative GS. Surgical site infection after gastrointestinal surgery in high-income, middle-income, and low-income countries: a prospective, international, multicentre cohort study. Lancet Infect Dis. 2018;18(5):516–525. doi: 10.1016/S1473-3099(18)30101-4.
    1. Bluebelle Study Group and the West Midlands Research Collaborative BLUEBELLE. Bluebelle study (phase A): a mixed-methods feasibility study to inform an RCT of surgical wound dressing strategies. BMJ Open. 2016;6(9):e012635. doi: 10.1136/bmjopen-2016-012635.
    1. Lima JL, de Aguiar RA, Leite HV, Silva HH, de Oliveira WM, Sacramento JP, et al. Surveillance of surgical site infection after cesarean section and time of notification. Am J Infect Control. 2016;44(3):273–277. doi: 10.1016/j.ajic.2015.10.022.
    1. Allegranzi B, Aiken AM, Zeynep Kubilay N, Nthumba P, Barasa J, Okumu G, Mugarura R, Elobu A, Jombwe J, Maimbo M, Musowoya J, Gayet-Ageron A, Berenholtz SM. A multimodal infection control and patient safety intervention to reduce surgical site infections in Africa: a multicentre, before-after, cohort study. Lancet Infect Dis. 2018;18(5):507–515. doi: 10.1016/S1473-3099(18)30107-5.
    1. Aiken AM, Wanyoro AK, Mwangi J, Mulingwa P, Wanjohi J, Njoroge J, Juma F, Mugoya IK, Scott JAG, Hall AJ. Evaluation of surveillance for surgical site infections in Thika Hospital. Kenya. J Hosp Infect. 2013;83(2):140–145. doi: 10.1016/j.jhin.2012.11.003.
    1. Nguhuni B, De Nardo P, Gentilotti E, Chaula Z, Damian C, Mencarini P, et al. Reliability and validity of using telephone calls for post-discharge surveillance of surgical site infection following caesarean section at a tertiary hospital in Tanzania. Antimicrob Resist Infect Control. 2017;6(1):43. doi: 10.1186/s13756-017-0205-0.
    1. Arie S. Can mobile phones transform healthcare in low and middle income countries. Bmj. 2015;350(apr22 20):h1975. doi: 10.1136/bmj.h1975.
    1. Bastawrous A, Armstrong MJ. Mobile health use in low- and high-income countries: an overview of the peer-reviewed literature. J R Soc Med. 2013;106(4):130–142. doi: 10.1177/0141076812472620.
    1. DAMOCLES Study Group A proposed charter for clinical trial data monitoring committees: helping them to do their job well. Lancet. 2005;365(9460):711–722. doi: 10.1016/S0140-6736(05)17965-3.
    1. Dron L, Taljaard M, Cheung YB, Grais R, Ford N, Thorlund K, Jehan F, Nakimuli-Mpungu E, Xavier D, Bhutta ZA, Park JJH, Mills EJ. The role and challenges of cluster randomised trials for global health. Lancet Glob Health. 2021;9(5):e701–e710. doi: 10.1016/S2214-109X(20)30541-6.

Source: PubMed

Patrocinadores e Colaboradores

Condições médicas

Intervenções de drogas

3
Se inscrever