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. 2023 Jan 30;2023(1):CD006207. doi: 10.1002/14651858.CD006207.pub6

Millar 2016.

Study characteristics
Methods Cluster‐RCT, open‐label study, factorial design
Participants Around 30,000 healthy, male army trainees aged 18 to 42 years at Fort Benning, Georgia were included. Inclusion criteria: trainees assigned to 1 of the 6 selected training battalions, trainees who present with an SSTI at the clinic or the hospital, provide informed consent. Exclusion criteria: fails to meet inclusion criteria. No denominator breakdown by arm is reported.
Interventions Promotion of hand‐washing in addition to a once‐weekly application of chlorhexidine‐based body wash. See Table 4 for details.
Outcomes This study was nested in a large field‐based RCT and utilised clinic‐based medical records.
Laboratory: none
Effectiveness: incidence of ARI at 20 months. The case definition was any occurrence of the following ICD‐9 symptom or disease‐specific codes: 460 to 466, 480 to 488, and specifically 465.9, 482.9, 486, and 487.1.
Safety: adverse effects neither planned nor reported by the investigators
Notes The period study conducted: May 2010 to January 2012
Government funded.
Declaration of interests: none declared.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk quote: "computer‐generated random numbers to 1 of the 3 study groups"
Allocation concealment (selection bias) Unclear risk No information provided.
Blinding of participants and personnel (performance bias)
All outcomes High risk The study was open‐label and self‐reporting of ARI. It is planned as secondary objective of an original trial. Data abstractors were blinded to group assignment.
Blinding of outcome assessment (detection bias)
All outcomes Low risk Data abstractors were blinded to group assignment.
Incomplete outcome data (attrition bias)
All outcomes High risk There is a statistically significant difference between attrition rates in the 3 groups. The reasons for attrition are briefly reported in Table 1 of the original study (Ellis and colleagues 2014), but are unlikely to be related to the outcomes of this study. ARI cases were captured utilising clinic‐based medical records, but this outcome is not prespecified in the protocol.
Selective reporting (reporting bias) High risk The study was conducted for another purpose. According to the study protocol, the outcomes of interest in the current report were not mentioned as outcomes when the study was planned. ARI is not prespecified as an outcome in the protocol published on ClinicalTrials.gov.