NCT03700749

Brief 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. Recruited participants will be randomly assigned to four arms to receive different combinations of skin preparation and sutures for would closure: A. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
5,480

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Nov 2018

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 9, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

November 29, 2018

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2021

Completed
Last Updated

September 26, 2019

Status Verified

September 1, 2019

Enrollment Period

2.7 years

First QC Date

August 23, 2018

Last Update Submit

September 24, 2019

Conditions

Abdominal SurgerySurgical Site Infection

Outcome Measures

Primary Outcomes (1)

  • 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.

    At 30-days post-surgery

Secondary Outcomes (9)

  • Physiological parameter - SSI at discharge from hospital

    Within 30-days post surgery from index operation

  • Mortality - patient mortality status

    Within 30-days post surgery from index operation

  • Physiological parameter - Unplanned wound opening

    Within 30-days post surgery from index operation

  • Re-operation for SSI

    Within 30-days post surgery from index operation

  • Length of hospital stay for index admission

    Within 30-days post surgery from index operation

  • +4 more secondary outcomes

Study Arms (4)

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.

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.

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.

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.

Drug: 10%povidone-iodine + coated suture

Interventions

2% chlorhexidine + non-coated sutureDRUG

Interventions: 2% alcoholic chlorhexidine non-coated suture

2%chlorhexidine + non-coated suture
2% chlorhexidine + coated sutureDRUG

Interventions: 2% alcoholic chlorhexidine triclosan coated suture

2%chlorhexidine + coated suture
10%povidone-iodine + non-coated sutureDRUG

Interventions: 10% povidone-iodine non-coated suture non-coated suture

10% povidone-iodine + non-coated suture
10%povidone-iodine + coated sutureDRUG

Interventions: 10% povidone-iodine triclosan coated suture

10%povidone-iodine + coated suture

Eligibility Criteria

AgeUp to 100 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lagos University Teaching Hospital

Lagos, Nigeria

RECRUITING

Related Publications (5)

  • 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.

    PMID: 39245053DERIVED

  • NIHR 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.

    PMID: 38747515DERIVED

  • Monahan 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.

    PMID: 37086854DERIVED

  • NIHR 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.

    PMID: 36328045DERIVED

  • NIHR 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.

    PMID: 34710362DERIVED

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Chlorhexidine

Condition Hierarchy (Ancestors)

Wound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Dion Morton

    University of Birmingham

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tina Griffin, BMedSc

CONTACT

0121 414 4762falcon@trials.bham.ac.uk

Rachel Lillywhite, BA

CONTACT

0121 414 4762GlobalSurg@trials.bham.ac.uk

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Patients and outcome assessors will be blinded. The operating surgeon will not perform outcome assessment.
Purpose
TREATMENT
Intervention Model
FACTORIAL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2018

First Posted

October 9, 2018

Study Start

November 29, 2018

Primary Completion

July 31, 2021

Study Completion

July 31, 2021

Last Updated

September 26, 2019

Record last verified: 2019-09

Locations

NG(1)