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)

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

doi:10.1186/s13063-022-06102-5

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)

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 NepogodievFaustin Ntirenganya, Omar Omar, Thomas Pinkney, Donna Smith^*, Stephen Tabiri, Neil Winkles

^*Corresponding author for this work

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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

Original language	English
Article number	204
Number of pages	14
Journal	Trials
Volume	23
Issue number	1
DOIs	https://doi.org/10.1186/s13063-022-06102-5
Publication status	Published - 9 Mar 2022

Keywords

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

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Correction: 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 & Morton, D., 15 Apr 2022, In: Trials. 23, 1, 1 p., 320.
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Ademuyiwa, A. O., Adisa, A. O., Bhangu, A., Brocklehurst, P., Chakrabortee, S., Ghosh, D., Glasbey, J., Haque, P. D., Hardy, P., Harrison, E., Ingabire, J. A., Ismail, L., Kadir, B., Lillywhite, R., Magill, L., De la medina, A. R., Moore, R., Monahan, M., Morton, D., ... Winkles, N. (2022). 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). Trials, 23(1), Article 204. https://doi.org/10.1186/s13063-022-06102-5

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title = "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)",

abstract = "BackgroundSurgical 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.MethodsThis 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.DiscussionChange 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 registrationClinicalTrials.gov NCT03980652. Registered on 9 July 2019",

keywords = "Surgical site infection, Sterile gloves and instruments, Infection control, Cluster randomised trial, Study protocol, Abdominal surgery, Gastrointestinal surgery",

author = "Ademuyiwa, {Adesoji O} and Adisa, {Adewale O.} and Aneel Bhangu and Peter Brocklehurst and Sohini Chakrabortee and Dhruva Ghosh and James Glasbey and Haque, {Parvez D} and Pollyanna Hardy and Ewen Harrison and Ingabire, {Jc Allen} and Lawani Ismail and Bryar Kadir and Rachel Lillywhite and Laura Magill and {De la medina}, {Antonio Ramos} and Rachel Moore and Mark Monahan and Dion Morton and Dmitri Nepogodiev and Faustin Ntirenganya and Omar Omar and Thomas Pinkney and Donna Smith and Stephen Tabiri and Neil Winkles",

year = "2022",

month = mar,

day = "9",

doi = "10.1186/s13063-022-06102-5",

language = "English",

volume = "23",

journal = "Trials",

issn = "1745-6215",

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number = "1",

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Ademuyiwa, AO, Adisa, AO, Bhangu, A , Brocklehurst, P, Chakrabortee, S, Ghosh, D, Glasbey, J, Haque, PD, Hardy, P, Harrison, E, Ingabire, JA, Ismail, L, Kadir, B, Lillywhite, R, Magill, L, De la medina, AR, Moore, R, Monahan, M, Morton, D , Nepogodiev, D, Ntirenganya, F, Omar, O , Pinkney, T, Smith, D, Tabiri, S & Winkles, N 2022, '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)', Trials, vol. 23, no. 1, 204. https://doi.org/10.1186/s13063-022-06102-5

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). / Ademuyiwa, Adesoji O; Adisa, Adewale O.; Bhangu, Aneel et al.
In: Trials, Vol. 23, No. 1, 204, 09.03.2022.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - 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)

AU - Ademuyiwa, Adesoji O

AU - Adisa, Adewale O.

AU - Bhangu, Aneel

AU - Brocklehurst, Peter

AU - Chakrabortee, Sohini

AU - Ghosh, Dhruva

AU - Glasbey, James

AU - Haque, Parvez D

AU - Hardy, Pollyanna

AU - Harrison, Ewen

AU - Ingabire, Jc Allen

AU - Ismail, Lawani

AU - Kadir, Bryar

AU - Lillywhite, Rachel

AU - Magill, Laura

AU - De la medina, Antonio Ramos

AU - Moore, Rachel

AU - Monahan, Mark

AU - Morton, Dion

AU - Nepogodiev, Dmitri

AU - Ntirenganya, Faustin

AU - Omar, Omar

AU - Pinkney, Thomas

AU - Smith, Donna

AU - Tabiri, Stephen

AU - Winkles, Neil

PY - 2022/3/9

Y1 - 2022/3/9

N2 - BackgroundSurgical 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.MethodsThis 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.DiscussionChange 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 registrationClinicalTrials.gov NCT03980652. Registered on 9 July 2019

AB - BackgroundSurgical 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.MethodsThis 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.DiscussionChange 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 registrationClinicalTrials.gov NCT03980652. Registered on 9 July 2019

KW - Surgical site infection

KW - Sterile gloves and instruments

KW - Infection control

KW - Cluster randomised trial

KW - Study protocol

KW - Abdominal surgery

KW - Gastrointestinal surgery

U2 - 10.1186/s13063-022-06102-5

DO - 10.1186/s13063-022-06102-5

M3 - Article

SN - 1745-6215

VL - 23

JO - Trials

JF - Trials

IS - 1

M1 - 204

ER -

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)

Abstract

Keywords

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Research output

Correction: 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)

Cite this