Abdominal SurgeryPhase 3FALCONNCT03700749
FALCON Trial Testing Measures to Reduce Surgical Site Infection
A Phase 3 study testing 2% chlorhexidine + non-coated suture, 2% chlorhexidine + coated suture and 10%povidone-iodine + non-coated suture in people with Abdominal Surgery and Surgical Site Infection, run by University of Birmingham at 1 site in Nigeria.
Trial summary
FALCON is a Pragmatic multi-centre trial testing measures to reduce superficial or deep skin infection following abdominal surgery in low and middle income countries. The trial will recruit patients undergoing abdominal surgery. Read more about this study
- Who is it for?
- Ages Up to 100 years
- Conditions the study is for
- Abdominal Surgery, Surgical Site Infection
- What is being tested?
- 2% chlorhexidine + non-coated suture, 2% chlorhexidine + coated suture and 10%povidone-iodine + non-coated suture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,480 participants
- Where
- 1 siteNigeria
- Study dates
- 29 Nov 2018to 31 Jul 2021
- Phase
- Phase 3
- 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 Up to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with at least one abdominal incision that is ≥5cm (open or laparoscopic extraction site), with an anticipated clean-contaminated, contaminated or dirty surgical wound.
- Patients undergoing emergency (surgery on an unplanned admission) or elective (surgery on a planned admission) operations.
- Any operative indication, including trauma surgery.
- Patient able and willing to provide written informed consent (signature or a fingerprint).
- Paediatric and adult patients. This criteria is made country-specific. Each country decides the lower age limit for the trial. This is dependent on country-specific regulatory approvals. Age eligibility will vary by country.
Who cannot join
- Patients with a documented or suspected allergy to iodine, shellfish, or chlorhexidine skin preparation solution.
- Patient unable to complete post-operative follow-up (i.e. will not be contactable after discharge).
Trial locations and contacts
1 site in 1 country.
Nigeria1 site, 1 recruiting
- Recruiting
Lagos University Teaching Hospital
Lagos
About this study
Official title: Pragmatic Multicentre FActorial Randomised Controlled triaL Testing Measures to reduCe Surgical Site Infection in lOw and Middle Income couNtries
FALCON is a Pragmatic multi-centre trial testing measures to reduce superficial or deep skin infection following abdominal surgery in low and middle income countries. The trial will recruit patients undergoing abdominal surgery. Recruited participants will be randomly assigned to four arms to receive different combinations of skin preparation and sutures for would closure:
- In this arm surgeon will use 2% alcoholic chlorhexidine for skin cleansing and non-coated suture for wound closure; B. In this arm surgeon will use 2% alcoholic chlorhexidine for skin cleansing and triclosan coated suture for wound closure; C. In this arm surgeon will use for operation 10% aqueous povidone-iodine for skin cleansing and non-coated suture for wound closure; D. In this arm surgeon will use 10% aqueous povidone-iodine for skin cleansing and triclosan-coated suture.
Read the detailed description
FALCON is a pragmatic, blinded (patient and outcome assessor), 2x2 factorial, stratified, multi-centre randomised controlled trial, with an internal pilot, to evaluate measures to reduce Surgical Site Infection (SSI) rates in patients undergoing surgery with an abdominal incision.
Surgical site infection (SSI) represents a major burden for patients, doctors, and health systems across all settings. SSI is the commonest postoperative complication worldwide and the commonest healthcare-associated infection in low and middle income countries (LMICs). SSIs cause pain, discomfort, disability, and increase the time taken to return to work (3). SSIs increase healthcare costs in all health settings. Whilst there is no direct data on the costs of SSI in LMICs, within the UK National Health Service, SSIs cost approximately £3500 per patient and £700 million per year in total. The impact of increased healthcare costs on patients, communities, and providers can be major in LMICs where personal income is low and patients may be required to pay for their own treatment. SSI has also been associated with one-third of postoperative deaths and accounts for 8% of all deaths caused by a hospital acquired infection.
Strata in FALCON trial are defined according to the anticipated category of wound contamination: (1) clean-contaminated and (2) contaminated/dirty. Eligible patients will be randomised at the level of the individual in a 1:1:1:1 ratio between:
- 2% alcoholic chlorhexidine and non-coated suture B. 2% alcoholic chlorhexidine and triclosan-coated suture C. 10% aqueous povidone-iodine and non-coated suture D. 10% aqueous povidone-iodine and triclosan-coated suture.
Participant will be recruited from hospitals in Low and Middle Income Countries (LMICs). Participants who is undergoing abdominal surgery with an anticipated clean-contaminated, contaminated or dirty surgical wound will be selected to enter the trial.
The 6 month internal pilot will assess the feasibility of recruitment, compliance with treatment allocation and patient retention and follow-up rates. The main RCT will recruit 5480 participants.
- Conditions
- Abdominal Surgery, Surgical Site Infection
- Being tested
- 2% chlorhexidine + non-coated suture, 2% chlorhexidine + coated suture, 10%povidone-iodine + non-coated suture, 10%povidone-iodine + coated suture
- 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.
2% chlorhexidine + non-coated sutureDrug
Interventions:
2% alcoholic chlorhexidine non-coated suture
2% chlorhexidine + coated sutureDrug
Interventions:
2% alcoholic chlorhexidine triclosan coated suture
10%povidone-iodine + non-coated sutureDrug
Interventions:
10% povidone-iodine non-coated suture non-coated suture
10%povidone-iodine + coated sutureDrug
Interventions:
10% povidone-iodine triclosan coated suture
| Study group | Role | What they receive |
|---|---|---|
| 2%chlorhexidine + non-coated suture | Active comparator | 2%alcoholic chlorhexidine + non-coated suture. Intervention: skin preparation with 2%alcoholic chlorhexidine in combination with non-coated suture for abdominal fascial closure. Receives: Drug: 2% chlorhexidine + non-coated suture |
| 2%chlorhexidine + coated suture | Active comparator | 2%alcoholic chlorhexidine + triclosan-coated suture. Intervention: skin preparation with 2%alcoholic chlorhexidine in combination with triclosan-coated suture for abdominal fascia closure. Receives: Drug: 2% chlorhexidine + coated suture |
| 10% povidone-iodine + non-coated suture | Active comparator | 10% povidone-iodine and non-coated suture. Intervention: skin preparation with 10% povidone-iodine in combination with non-coated suture for abdominal fascial closure. Receives: Drug: 10%povidone-iodine + non-coated suture |
| 10%povidone-iodine + coated suture | Active comparator | 10%povidone-iodine/triclosan-coated suture. Intervention: skin preparation with 10% povidone-iodine in combination with triclosan-coated suture for abdominal fascial closure. Receives: Drug: 10%povidone-iodine + coated suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical site infection (SSI)
Deep incisional or superficial incisional SSI which must occur within 30 days of the index operation. The infection must involve the skin, subcutaneous, muscular or fascial layers of the incision. Patient must at least have one of the following: (1) purulent discharge from wound; (2) organisms detected from wound swab; (3) Wound opened spontaneously or by a clinician AND, at the surgical wound, the patient has at least one of: pain or tenderness; localised swelling; redness; heat; systemic fever (>38°C); (4) Diagnosis of SSI by a clinician or on imaging.
Measured: At 30-days post-surgery
Secondary outcomes (9)
Physiological parameter - SSI at discharge from hospital
Deep incisional or superficial incisional SSI. The infection must involve the skin, subcutaneous, muscular or fascial layers of the incision and the patient must have one of the following: (1) purulent discharge from wound; (2) organisms detected from wound swab; (3) Wound opened spontaneously or by a clinician AND, at the surgical wound, the patient has at least one of: pain or tenderness; localised swelling; redness; heat; systemic fever (>38°C); (4) Diagnosis of SSI by a clinician or on imaging.
Measured: Within 30-days post surgery from index operation
Mortality - patient mortality status
Mortality within 30-days post surgery
Measured: Within 30-days post surgery from index operation
Physiological parameter - Unplanned wound opening
Whether an unplanned wound opening has occurred at abdominal surgical site within 30-days post surgery, spontaneously opened or by clinician
Measured: Within 30-days post surgery from index operation
Re-operation for SSI
Re-operation for SSI within 30-days post surgery
Measured: Within 30-days post surgery from index operation
Length of hospital stay for index admission
Length of hospital stay for index admission will be collected and will measure time from surgery to time of discharge.
Measured: Within 30-days post surgery from index operation
Participant's Readmission
Whether patient readmitted within 30-days post surgery
Measured: Within 30-days post surgery from index operation
Questionnaire - return to normal activities
Return to normal activities (e.g. work, school, or family duties) ascertained by trial specific questionnaire
Measured: Within 30-days post surgery from index operation
Resistance of organisms
Resistance of organisms detected from wound swabs to prophylactic antibiotics administered within 1 hour of incision
Measured: Within 30-days post surgery from index operation
Questionnaire - Health resource usage
Health resource usage within 30-days post surgery ascertained by trial specific questionnaire
Measured: Within 30-days post surgery. Health resource usage will only be collected for adult patients (aged 18 and above) at pre-selected centres. This will include costs of post-operative visits to various healthcare professionals.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start29 Nov 2018
- Primary completion31 Jul 2021 (estimated)
- Study completion31 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Abdominal SurgeryStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- FALCON 2x2 factorial trial with strata: (1) clean-contaminated and (2) contaminated/dirty. Eligible patients will be randomised at the level of the individual in a 1:1:1:1 ratio between: A. 2% alcoholic chlorhexidine and non-coated suture B. 2% alcoholic chlorhexidine and triclosan-coated suture C. 10% aqueous povidone-iodine and non-coated suture D. 10% aqueous povidone-iodine and triclosan-coated suture
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 5,480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Lagos State University, Universidad Francisco Marroquín, Kigali University Teaching Hospital, Christian Medical College and Hospital, Ludhiana, India, University of Edinburgh, University of the Philippines, King Edward Medical University, University of Witwatersrand, South Africa, Universidad Peruana Cayetano Heredia, Centre National Hospitalier Universitaire, Ndola Teaching Hospital, Hospital Espanol de Veracruz, Ministry of Health, Ghana
- Responsible party
- Sponsor
- Investigators
- Dion Morton, Principal investigator, University of Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03700749
- Sponsor's protocol ID
- RG_17-126
- Acronym
- FALCON
- Status last verified
- Sep 2019
- First submitted
- 23 Aug 2018
- Last updated
- 26 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
NIHR Global Health Research Unit on Global Surgery. Mechanisms and causes of death after abdominal surgery in low-income and middle-income countries: a secondary analysis of the FALCON trial. Lancet Glob Health. 2024 Nov;12(11):e1807-e1815. doi: 10.1016/S2214-109X(24)00318-8. Epub 2024 Sep 5.
PubMed 39245053NIHR Global Health Research Unit on Global Surgery. Accuracy of the Wound Healing Questionnaire in the diagnosis of surgical-site infection after abdominal surgery in low- and middle-income countries. Br J Surg. 2024 Jan 31;111(2):znad446. doi: 10.1093/bjs/znad446.
PubMed 38747515Monahan M, Glasbey J, Roberts TE, Jowett S, Pinkney T, Bhangu A, Morton DG, de la Medina AR, Ghosh D, Ademuyiwa AO, Ntirenganya F, Tabiri S; NIHR Global Research Health Unit on Global Surgery. The costs of surgical site infection after abdominal surgery in middle-income countries: Key resource use In Wound Infection (KIWI) study. J Hosp Infect. 2023 Jun;136:38-44. doi: 10.1016/j.jhin.2023.03.023. Epub 2023 Apr 21.
PubMed 37086854NIHR Global Research Health Unit on Global Surgery. Routine sterile glove and instrument change at the time of abdominal wound closure to prevent surgical site infection (ChEETAh): a pragmatic, cluster-randomised trial in seven low-income and middle-income countries. Lancet. 2022 Nov 19;400(10365):1767-1776. doi: 10.1016/S0140-6736(22)01884-0. Epub 2022 Oct 31.
PubMed 36328045NIHR Global Research Health 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 Nov 6;398(10312):1687-1699. doi: 10.1016/S0140-6736(21)01548-8. Epub 2021 Oct 25.
PubMed 34710362
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pragmatic Multicentre FActorial Randomised Controlled triaL Testing Measures to reduCe Surgical Site Infection in lOw and Middle Income couNtries
- ClinicalTrials.gov ID
- NCT03700749
- Acronym / sponsor ID
- FALCON / RG_17-126
- Conditions
- Abdominal Surgery, Surgical Site Infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5,480 participants (estimated)
- Lead sponsor
- University of BirminghamUniversity, hospital or other
- Collaborators
- Lagos State University, Universidad Francisco Marroquín, Kigali University Teaching Hospital, Christian Medical College and Hospital, Ludhiana, India, University of Edinburgh, University of the Philippines, King Edward Medical University, University of Witwatersrand, South Africa, Universidad Peruana Cayetano Heredia, Centre National Hospitalier Universitaire, Ndola Teaching Hospital, Hospital Espanol de Veracruz, Ministry of Health, Ghana
- Study start
- 29 Nov 2018 (actual)
- Primary completion
- 31 Jul 2021 (estimated)
- Study completion
- 31 Jul 2021 (estimated)
- First posted
- 9 Oct 2018 (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.
FALCON is a Pragmatic multi-centre trial testing measures to reduce superficial or deep skin infection following abdominal surgery in low and middle income countries. The trial will recruit patients undergoing abdominal surgery. Recruited participants will be randomly assigned to four arms to receive different combinations of skin preparation and sutures for would closure:
- In this arm surgeon will use 2% alcoholic chlorhexidine for skin cleansing and non-coated suture for wound closure; B. In this arm surgeon will use 2% alcoholic chlorhexidine for skin cleansing and triclosan coated suture for wound closure; C. In this arm surgeon will use for operation 10% aqueous povidone-iodine for skin cleansing and non-coated suture for wound closure; D. In this arm surgeon will use 10% aqueous povidone-iodine for skin cleansing and triclosan-coated suture.
Detailed description
FALCON is a pragmatic, blinded (patient and outcome assessor), 2x2 factorial, stratified, multi-centre randomised controlled trial, with an internal pilot, to evaluate measures to reduce Surgical Site Infection (SSI) rates in patients undergoing surgery with an abdominal incision.
Surgical site infection (SSI) represents a major burden for patients, doctors, and health systems across all settings. SSI is the commonest postoperative complication worldwide and the commonest healthcare-associated infection in low and middle income countries (LMICs). SSIs cause pain, discomfort, disability, and increase the time taken to return to work (3). SSIs increase healthcare costs in all health settings. Whilst there is no direct data on the costs of SSI in LMICs, within the UK National Health Service, SSIs cost approximately £3500 per patient and £700 million per year in total. The impact of increased healthcare costs on patients, communities, and providers can be major in LMICs where personal income is low and patients may be required to pay for their own treatment. SSI has also been associated with one-third of postoperative deaths and accounts for 8% of all deaths caused by a hospital acquired infection.
Strata in FALCON trial are defined according to the anticipated category of wound contamination: (1) clean-contaminated and (2) contaminated/dirty. Eligible patients will be randomised at the level of the individual in a 1:1:1:1 ratio between:
- 2% alcoholic chlorhexidine and non-coated suture B. 2% alcoholic chlorhexidine and triclosan-coated suture C. 10% aqueous povidone-iodine and non-coated suture D. 10% aqueous povidone-iodine and triclosan-coated suture.
Participant will be recruited from hospitals in Low and Middle Income Countries (LMICs). Participants who is undergoing abdominal surgery with an anticipated clean-contaminated, contaminated or dirty surgical wound will be selected to enter the trial.
The 6 month internal pilot will assess the feasibility of recruitment, compliance with treatment allocation and patient retention and follow-up rates. The main RCT will recruit 5480 participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- FALCON 2x2 factorial trial with strata: (1) clean-contaminated and (2) contaminated/dirty. Eligible patients will be randomised at the level of the individual in a 1:1:1:1 ratio between: A. 2% alcoholic chlorhexidine and non-coated suture B. 2% alcoholic chlorhexidine and triclosan-coated suture C. 10% aqueous povidone-iodine and non-coated suture D. 10% aqueous povidone-iodine and triclosan-coated suture
| Arm | Type | Receives |
|---|---|---|
| 2%chlorhexidine + non-coated suture | Active comparator | Drug: 2% chlorhexidine + non-coated suture2%alcoholic chlorhexidine + non-coated suture. Intervention: skin preparation with 2%alcoholic chlorhexidine in combination with non-coated suture for abdominal fascial closure. |
| 2%chlorhexidine + coated suture | Active comparator | Drug: 2% chlorhexidine + coated suture2%alcoholic chlorhexidine + triclosan-coated suture. Intervention: skin preparation with 2%alcoholic chlorhexidine in combination with triclosan-coated suture for abdominal fascia closure. |
| 10% povidone-iodine + non-coated suture | Active comparator | Drug: 10%povidone-iodine + non-coated suture10% povidone-iodine and non-coated suture. Intervention: skin preparation with 10% povidone-iodine in combination with non-coated suture for abdominal fascial closure. |
| 10%povidone-iodine + coated suture | Active comparator | Drug: 10%povidone-iodine + coated suture10%povidone-iodine/triclosan-coated suture. Intervention: skin preparation with 10% povidone-iodine in combination with triclosan-coated suture for abdominal fascial closure. |
Who may qualify
- Ages
- Up to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with at least one abdominal incision that is ≥5cm (open or laparoscopic extraction site), with an anticipated clean-contaminated, contaminated or dirty surgical wound.
- Patients undergoing emergency (surgery on an unplanned admission) or elective (surgery on a planned admission) operations.
- Any operative indication, including trauma surgery.
- Patient able and willing to provide written informed consent (signature or a fingerprint).
- Paediatric and adult patients. This criteria is made country-specific. Each country decides the lower age limit for the trial. This is dependent on country-specific regulatory approvals. Age eligibility will vary by country.
Key exclusion criteria (2 listed)
- Patients with a documented or suspected allergy to iodine, shellfish, or chlorhexidine skin preparation solution.
- Patient unable to complete post-operative follow-up (i.e. will not be contactable after discharge).
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 |
|---|---|---|
| 2% chlorhexidine + non-coated sutureInterventions: 2% alcoholic chlorhexidine non-coated suture | Drug | 2%chlorhexidine + non-coated suture |
| 2% chlorhexidine + coated sutureInterventions: 2% alcoholic chlorhexidine triclosan coated suture | Drug | 2%chlorhexidine + coated suture |
| 10%povidone-iodine + non-coated sutureInterventions: 10% povidone-iodine non-coated suture non-coated suture | Drug | 10% povidone-iodine + non-coated suture |
| 10%povidone-iodine + coated sutureInterventions: 10% povidone-iodine triclosan coated suture | Drug | 10%povidone-iodine + coated suture |
Primary outcome
Surgical site infection (SSI)
Time frame: At 30-days post-surgery
Deep incisional or superficial incisional SSI which must occur within 30 days of the index operation. The infection must involve the skin, subcutaneous, muscular or fascial layers of the incision. Patient must at least have one of the following: (1) purulent discharge from wound; (2) organisms detected from wound swab; (3) Wound opened spontaneously or by a clinician AND, at the surgical wound, the patient has at least one of: pain or tenderness; localised swelling; redness; heat; systemic fever (>38°C); (4) Diagnosis of SSI by a clinician or on imaging.
9 secondary outcomes
Physiological parameter - SSI at discharge from hospital
Time frame: Within 30-days post surgery from index operation
Mortality - patient mortality status
Time frame: Within 30-days post surgery from index operation
Physiological parameter - Unplanned wound opening
Time frame: Within 30-days post surgery from index operation
Re-operation for SSI
Time frame: Within 30-days post surgery from index operation
Length of hospital stay for index admission
Time frame: Within 30-days post surgery from index operation
Participant's Readmission
Time frame: Within 30-days post surgery from index operation
Questionnaire - return to normal activities
Time frame: Within 30-days post surgery from index operation
Resistance of organisms
Time frame: Within 30-days post surgery from index operation
Questionnaire - Health resource usage
Time frame: Within 30-days post surgery. Health resource usage will only be collected for adult patients (aged 18 and above) at pre-selected centres. This will include costs of post-operative visits to various healthcare professionals.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2019.
- Derived from this study: PubMed 39245053NIHR Global Health Research Unit on Global Surgery. Mechanisms and causes of death after abdominal surgery in low-income and middle-income countries: a secondary analysis of the FALCON trial. Lancet Glob Health. 2024 Nov;12(11):e1807-e1815. doi: 10.1016/S2214-109X(24)00318-8. Epub 2024 Sep 5.
- Derived from this study: PubMed 38747515NIHR Global Health Research Unit on Global Surgery. Accuracy of the Wound Healing Questionnaire in the diagnosis of surgical-site infection after abdominal surgery in low- and middle-income countries. Br J Surg. 2024 Jan 31;111(2):znad446. doi: 10.1093/bjs/znad446.
- Derived from this study: PubMed 37086854Monahan M, Glasbey J, Roberts TE, Jowett S, Pinkney T, Bhangu A, Morton DG, de la Medina AR, Ghosh D, Ademuyiwa AO, Ntirenganya F, Tabiri S; NIHR Global Research Health Unit on Global Surgery. The costs of surgical site infection after abdominal surgery in middle-income countries: Key resource use In Wound Infection (KIWI) study. J Hosp Infect. 2023 Jun;136:38-44. doi: 10.1016/j.jhin.2023.03.023. Epub 2023 Apr 21.
- Derived from this study: PubMed 36328045NIHR Global Research Health Unit on Global Surgery. Routine sterile glove and instrument change at the time of abdominal wound closure to prevent surgical site infection (ChEETAh): a pragmatic, cluster-randomised trial in seven low-income and middle-income countries. Lancet. 2022 Nov 19;400(10365):1767-1776. doi: 10.1016/S0140-6736(22)01884-0. Epub 2022 Oct 31.
- Derived from this study: PubMed 34710362NIHR Global Research Health 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 Nov 6;398(10312):1687-1699. doi: 10.1016/S0140-6736(21)01548-8. Epub 2021 Oct 25.
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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.
Dion Morton principal investigator
University of Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 2% chlorhexidine + non-coated suture, 2% chlorhexidine + coated suture and 10%povidone-iodine + non-coated suture in people with Abdominal Surgery and Surgical Site Infection, run by University of Birmingham at 1 site in Nigeria.
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 5 inclusion and 2 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 26 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nigeria. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Tina Griffin, BMedSc (0121 414 4762, falcon@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) (time frame: At 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 NCT03700749, which also lists 5 linked publications.
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 26 Sep 2019.