Antiseptic efficacy and plasma chlorhexidine levels following two different methods of application of 1% aqueous chlorhexidine gluconate for skin disinfection in preterm newborns: a randomized controlled trial.

Objective: Many neonatal units have started using Chlorhexidine gluconate for neonatal skin antisepsis. However, there is in-vitro evidence of inhibition of neurite growth. The current study aimed to compare two methods of its local application, for the extent of systemic absorption and antiseptic efficacy.
Study Design: Parallel group, blinded, randomised trial, at a Level III, neonatal intensive care unit. Between December 2020 to July 2022, neonates from 28 to 34 weeks gestation, were randomized to local skin antisepsis by either- (a) 1% aqueous chlorhexidine (CHG aq) followed by cleansing off the residual agent with sterile water swab (Cleansing group) or (b)1% CHG aq followed by air drying (No cleansing group). The outcome measures were the proportion of post antisepsis skin swabs with no/insignificant growth, and the plasma chlorhexidine levels.
Results: Of the total of 457 enrollments (Cleansing: n = 230; No Cleansing: n = 227), 216 (93.91%) in "Cleansing" vs. 221 (97.36%) in "No cleansing" (risk difference -3.45%, 95% CI -7.2 to 0.28%; p = 0.072) had no/insignificant growth post-antisepsis. The lower bound of the confidence interval crossed the pre-specified non-inferiority limit of 5%. The median (IQR) plasma chlorhexidine levels were not significantly different between the two groups (7.9 (5.6, 17.9)) ng/mL in Cleansing vs. 6.5 (4.6, 17.7) in No cleansing groups (p = 0.437).
Conclusion: Cleansing with sterile water after application of chlorhexidine in preterm neonates was not shown to be non-inferior compared to no cleansing, for skin antisepsis efficacy. Systemic absorption occurred to a similar extent despite cleansing off the residual agent.
Trial Registration Number: CTRI/2020/10/028719.
Competing Interests: Competing interests: The authors declare no competing interests. Study approval statement: This study protocol was reviewed and approved by the Institutional Ethics Committee of the All India Institute of Medical Sciences, New Delhi with approval number IECPG-429/26.08.2020, RT-20/ 23.09.2020 and was prospectively registered in Clinical Trials Registry- India (CTRI) with registration number CTRI/2020/10/028719. Consent to participate statement: Written informed consent was obtained from parents/legal guardians for the neonates to participate in the study.
(© 2024. The Author(s), under exclusive licence to Springer Nature America, Inc.)