Surgical Site InfectionCheetahNCT03980652
Cheetah - Sterile Glove and Clean Instrument Change at the Time of Wound Closure to Reduce Surgical Site Infection
A study testing Change of gloves and sterile instruments in people with Surgical Site Infection, run by University of Birmingham.
Trial summary
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 Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Surgical Site Infection
- What is being tested?
- Change of gloves and sterile instruments
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12,800 participants
- Where
- No sites listed yet
- Study dates
- May 2020to Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Countries: LMICs defined by the Development Assistance Committee (DAC) Official Development Assistance (ODA) list where there are at least 4 eligible hospitals per country in HIC-CHEETAH protocol (HICs are those that do not appear on the Organisation for Economic Co-operation and Development's Official Development Assistance (ODA) list
- Hospitals (clusters): in LMICs where glove and instrument change is not currently routine hospital practice
- Participants: Patients undergoing abdominal surgery who satisfy the following criteria are eligible:
- Emergency (surgery on an unplanned admission) or elective (surgery on a planned admission)
- Intraoperative finding of clean-contaminated, contaminated or dirty surgery
- with at least one abdominal incision that is ≥5cm
Show all 9Show fewer
- Aged 16 years and over on the day of surgery (applicable to HIC-CHEETAH protocol only)
- Participant Exclusion Criteria:
- Patients undergoing caesarean section
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Cheetah - a Cluster Randomized Trial of Sterile Glove and Clean Instrument Change at the Time of Wound Closure to Reduce Surgical Site Infection (SSI). A Trial in Low and Middle Income Countries (LMICs) and A Trial in High Income Countries (HICs)
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
Read the detailed description
Internal Pilot
The aim of the 12-month internal pilot is to assess:
- whether hospitals adhere to their allocation
- what proportion of patients who are eligible for ChEETAh can be followed up successfully at 30 days after their surgery
Main Study
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
- Conditions
- Surgical Site Infection
- Being tested
- Change of gloves and sterile instruments
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Change of gloves and sterile instrumentsProcedure or surgery
Change of gloves and use of separate , sterile instruments before closing the abdominal wall
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Other | Change of gloves and use of separate, sterile instruments before closing the abdominal wall Receives: Procedure: Change of gloves and sterile instruments |
| Current routine hospital practice | No intervention | No change of gloves or use of separate, sterile instruments before closing the abdominal wall |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical Site Infection (SSI) at 30-days post-surgery
The Centre for Disease Control (CDC) definition will be used in ChEETAh to identify deep incisional or superficial incisional SSIs
Measured: 30-days post-surgery
Secondary outcomes (5)
SSI before discharge from hospital
SSI will be assessed following the index operation, at the point of discharge, and assessed according to the Centre for Disease Control (CDC) criteria
Measured: up to 30 days
Re-admission
Unexpected re-admission into hospital for a wound-related problem within 30-days post surgery
Measured: within 30-days post-surgery
Length of hospital stay
Length of hospital stay following surgery
Measured: Length of hospital stay for the index operation and assessed at the point of discharge up to 30 days
Return to normal activities e.g (work, school, or family duties)
Return to normal activities from the date of the index operation will be assessed by a questionnaire via telephone and analysed by the Centre for Disease Control (CDC) criteria.
Measured: The assessment will be made up to 30-days from the index operation.
Death
within 30 days of surgery
Measured: within 30 days post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2019
- Study startMay 2020 (estimated)
- Primary completionJun 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Surgical Site InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster randomised controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mr Aneel Bhangu, Principal investigator, University of Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03980652
- Sponsor's protocol ID
- 1234
- Acronym
- Cheetah
- Status last verified
- Apr 2020
- First submitted
- 3 Jun 2019
- Last updated
- 24 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
NIHR Global Health Research Unit on Global Surgery. 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. 2022 Mar 9;23(1):204. doi: 10.1186/s13063-022-06102-5.
PubMed 35264227
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cheetah - a Cluster Randomized Trial of Sterile Glove and Clean Instrument Change at the Time of Wound Closure to Reduce Surgical Site Infection (SSI). A Trial in Low and Middle Income Countries (LMICs) and A Trial in High Income Countries (HICs)
- ClinicalTrials.gov ID
- NCT03980652
- Acronym / sponsor ID
- Cheetah / 1234
- Conditions
- Surgical Site Infection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12,800 participants (estimated)
- Lead sponsor
- University of BirminghamUniversity, hospital or other
- Study start
- May 2020 (estimated)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 10 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Internal Pilot
The aim of the 12-month internal pilot is to assess:
- whether hospitals adhere to their allocation
- what proportion of patients who are eligible for ChEETAh can be followed up successfully at 30 days after their surgery
Main Study
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Cluster randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Intervention | Other | Procedure: Change of gloves and sterile instrumentsChange of gloves and use of separate, sterile instruments before closing the abdominal wall |
| Current routine hospital practice | No intervention | –No change of gloves or use of separate, sterile instruments before closing the abdominal wall |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Countries: LMICs defined by the Development Assistance Committee (DAC) Official Development Assistance (ODA) list where there are at least 4 eligible hospitals per country in HIC-CHEETAH protocol (HICs are those that do not appear on the Organisation for Economic Co-operation and Development's Official Development Assistance (ODA) list
- Hospitals (clusters): in LMICs where glove and instrument change is not currently routine hospital practice
- Participants: Patients undergoing abdominal surgery who satisfy the following criteria are eligible:
- Emergency (surgery on an unplanned admission) or elective (surgery on a planned admission)
- Intraoperative finding of clean-contaminated, contaminated or dirty surgery
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Change of gloves and sterile instrumentsChange of gloves and use of separate , sterile instruments before closing the abdominal wall | Procedure or surgery | Intervention |
Primary outcome
Surgical Site Infection (SSI) at 30-days post-surgery
Time frame: 30-days post-surgery
The Centre for Disease Control (CDC) definition will be used in ChEETAh to identify deep incisional or superficial incisional SSIs
5 secondary outcomes
SSI before discharge from hospital
Time frame: up to 30 days
Re-admission
Time frame: within 30-days post-surgery
Length of hospital stay
Time frame: Length of hospital stay for the index operation and assessed at the point of discharge up to 30 days
Return to normal activities e.g (work, school, or family duties)
Time frame: The assessment will be made up to 30-days from the index operation.
Death
Time frame: within 30 days post-surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2020.
- Derived from this study: PubMed 35264227NIHR Global Health Research Unit on Global Surgery. 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. 2022 Mar 9;23(1):204. doi: 10.1186/s13063-022-06102-5.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mr Aneel Bhangu principal investigator
University of Birmingham
Questions about this trial
What is this clinical trial studying?
A study testing Change of gloves and sterile instruments in people with Surgical Site Infection, run by University of Birmingham.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Donna Smith (+44(0)121 415 9103, cheetah@trials.bham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical Site Infection (SSI) at 30-days post-surgery (time frame: 30-days post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03980652, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2020.