Correspondence
high quality. Inclusion of a study that further investi­gation.
confounds the assessment of deep
versus superficial infections when only
deep sutures are triclosan-coated and
contributes 45% of the data weighting
in the meta-analysis could lead to a
bias towards the null.
We believe that a re-analysis of
only the deep incisional infections in
the FALCON trial would help inform
our collective understanding of the
contribution of triclosan-coated
sutures to SSI prevention.
N-DS, SZ, and JC are currently employees of Johnson
& Johnson. JB is an adjunct faculty member at
Rutgers University and is a statistical editor for JAMA
Network Open; he is being paid as a consultant to
contribute to this work. LO is a retired employee of
Ethicon, currently working as a paid consultant.
*Niels-Derrek Schmitz, Liza Ovington,
Jesse Berlin, Shumin Zhang, John Collier
nschmit3@its.jnj.com
Ethicon, Bridgewater, NJ 08807, USA (N-DS, JC, LO);
Johnson & Johnson, New Brunswick, NJ, USA (SZ);
Center for Pharmacoepidemiology and Treatment,
Rutgers University, New Brunswick, NJ, USA (JB)
1 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;
398: 1687–99.
2 Elek SD, Conen PE. The virulence of
Staphylococcus pyogenes for man; a study of
the problems of wound infection.
Br J Exp Pathol 1957; 38: 573–86.
3 National Institute of Health Research Unit on
Global Surgery. Alcoholic chlorhexidine skin
preparation or triclosan-coated sutures to
reduce surgical site infection: a systematic
review and meta-analysis of high-quality
randomised controlled trials. Lancet Infect Dis
2022; 22: 1242–51.
Authors’ response
We thank Niels-Derrek Schmitz and
colleagues for their letter about the
FALCON trial.1 In keeping with our
hypothesis, we did not test triclosan-
coated sutures for skin closure but we
did test them for closure of the deep
abdominal wall fascia. The deep fascia
is where our network identified clinical
equipoise and the highest likelihood of a
clinically meaningful effect. Since we are
unable to comment on the effectiveness
of triclosan-coated skin sutures (which
are a different product to that used to
close the fascia), these could influence
minor superficial infections, warranting
1498
Adesoji Ademuyiwa,
We combined the definitions of
deep and superficial surgical site
infections (SSIs) of the abdominal wall
in the FALCON trial for two reasons.
First, the difference between deep
and superficial infections is subjective
and differentiating these is unlikely
to be reliable in widespread clinical
practice. Second, there is likely to be
substantial overlap between deep
and superficial infections, making it
practically hard to separate them as
entities in real-world practice. This
overlap between deep and superficial
infections contrasts with organ space
infections, which are clearly separate
and which we did not include, as
there is no biological rationale. We
did not collect data that would permit
the suggested secondary analysis of
superficial versus deep infections since
we concentrated on our prespecified,
protocolised primary hypothesis and
focused data collection towards that,
for more efficient front-line delivery
of the trial. Our analysis of reoperation
rates (a treatment for some deep
SSIs), however, did not show any
difference between coated and non-
coated sutures.
The authors also comment on our
meta-analysis in The Lancet Infectious
Diseases. 2 Like all meta-analyses,
this meta-analysis was designed to
inform debate in clinical practice
and policy by applying evidence-
based medicine. It does suggest that
the profound benefits seen for both
interventions tested in the FALCON
trial (skin preparation and coated
sutures) might be explained by high
levels of bias.
Further secondary analysis of
FALCON trial data could identify
subgroups where a signal of effect
justifies further evaluation. Such
analysis needs to be pre-planned and
executed to a high methodological
standard. We would be delighted
to collaborate with the authors
to achieve this, which is currently
beyond the scope of this response.
We declare no competing interests.
Dmitri Nepogodiev, Stephen Tabiri,
*Aneel Bhangu
a.a.bhangu@bham.ac.uk
Department of Surgery, College of Medicine,
University of Lagos, Lagos, Nigeria (AA); Institute of
Applied Health Research, University of Birmingham,
Birmingham B15 2TH, UK (DN, AB); School of
Medicine and Health Sciences, University for
Development Studies, Tamale, Ghana (ST)
1 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;
398: 1687–99.
2 National Institute of Health Research Unit on
Global Surgery. Alcoholic chlorhexidine skin
preparation or triclosan-coated sutures to
reduce surgical site infection: a systematic
review and meta-analysis of high-quality
randomised controlled trials. Lancet Infect Dis
2022; 22: 1242–51.
Department of Error
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established status epilepticus by age group
(ESETT): a double-blind, responsive-adaptive,
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395: 1217–24—For this Article,
Angela Lumba-Brown’s name has been
corrected in the list of Pediatric Emergency
Care Applied Research Network investigators
and in the appendix. This correction has been
made to the online version as of May 4, 2023.
Allinson JP, Chaturvedi N, Wong A, et al. Early
childhood lower respiratory tract infection and
premature adult death from respiratory disease in
Great Britain: a national birth cohort study.
Lancet 2023; 401: 1183–93—In figure 4D of
this Article, the red line and blue line in the key
were inverted. This correction has been made
to the online version as of May 4, 2023.
www.thelancet.com Vol 401 May 6, 2023