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Effect of alcohol skin cleansing on vaccination-associated infections and local skin reactions: a randomized controlled trial.

ABSTRACT: OBJECTIVES:Recommendations regarding the need to use alcohol prior to vaccine injections are inconsistent and based on low-level evidence. The objective was to assess the effectiveness of alcohol in reducing local skin reactions and infection post-vaccination. METHODS:Randomized controlled trial in a pediatric clinic. A research assistant cleansed the skin with alcohol at (swab group) or adjacent to (control group) the pre-defined injection site(s). Clinicians, parents and children were blinded to group allocation. Parents reported local skin reactions using paper diaries for 15 days post-vaccination (Day 0-14). Telephone interviews were conducted Day 1, 5, and 14. The Brighton Collaboration criteria were used to diagnose cellulitis and infectious abscess Day 5 and afterward. RESULTS:170 children participated (May-November 2017). Baseline characteristics did not differ (p > 0.05) between groups. Children received 1-4 separate injections. There were no differences between swab and control groups in the incidence of any local skin reactions (58% vs. 54%), and specifically, pain (45% vs. 40%), redness (26% vs. 21%), swelling (20% vs. 13%), warmth (19% vs. 27%), and spontaneous drainage of pus (0% in both groups) over the post-vaccination follow-up period. Day 5 data was available for 99% of participants from diaries and telephone surveys; there were no cases of cellulitis or infectious abscess. CONCLUSION:These findings are the first direct evidence for vaccine injections demonstrating that cleansing the skin with alcohol may not be needed. Our study is underpowered; however, to detect a difference in incidence of skin infection, future research is recommended.

SUBMITTER: Wong H

PROVIDER: S-EPMC6605859 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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Effect of alcohol skin cleansing on vaccination-associated infections and local skin reactions: a randomized controlled trial.

Wong Horace H Moss Corinne C Moss Steven M SM Shah Vibhuti V Halperin Scott A SA Ito Shinya S Mithal Priyanjali P Qu Angie A Taddio Anna A

Human vaccines & immunotherapeutics 20190116 4

<h4>Objectives</h4>Recommendations regarding the need to use alcohol prior to vaccine injections are inconsistent and based on low-level evidence. The objective was to assess the effectiveness of alcohol in reducing local skin reactions and infection post-vaccination.<h4>Methods</h4>Randomized controlled trial in a pediatric clinic. A research assistant cleansed the skin with alcohol at (swab group) or adjacent to (control group) the pre-defined injection site(s). Clinicians, parents and childre ...[more]

PMID: 30513266

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Project description:Hospital-based data from Africa suggest that newborn skin-cleansing with chlorhexidine may reduce neonatal mortality. Evaluation of this intervention in the communities where most births occur in the home has not been done. Our objective was to assess the efficacy of a 1-time skin-cleansing of newborn infants with 0.25% chlorhexidine on neonatal mortality.The design was a community-based, placebo-controlled, cluster-randomized trial in Sarlahi District in southern Nepal. Newborn infants were cleansed with infant wipes that contained 0.25% chlorhexidine or placebo solution as soon as possible after delivery in the home (median: 5.8 hours). The primary outcome was all-cause mortality by 28 days. After the completion of the randomized phase, all newborns in study clusters were converted to chlorhexidine treatment for the subsequent 9 months.A total of 17,530 live births occurred in the enrolled sectors, 8650 and 8880 in the chlorhexidine and placebo groups, respectively. Baseline characteristics were similar in the treatment groups. Intention-to-treat analysis among all live births showed no impact of the intervention on neonatal mortality. Among live-born infants who actually received their assigned treatment (98.7%), there was a nonsignificant 11% lower neonatal mortality rate among those who were treated with chlorhexidine compared with placebo. Low birth weight infants had a statistically significant 28% reduction in neonatal mortality; there was no significant difference among infants who were born weighing > or = 2500 g. After conversion to active treatment in the placebo clusters, there was a 37% reduction in mortality among low birth weight infants in the placebo clusters versus no change in the chlorhexidine clusters.Newborn skin-wiping with chlorhexidine solution once, soon after birth, reduced neonatal mortality only among low birth weight infants. Evidence from additional trials is needed to determine whether this inexpensive and simple intervention could improve survival significantly among low birth weight infants in settings where home delivery is common and hygiene practices are poor.

Dataset Information

Effect of alcohol skin cleansing on vaccination-associated infections and local skin reactions: a randomized controlled trial.

Publications

Effect of alcohol skin cleansing on vaccination-associated infections and local skin reactions: a randomized controlled trial.

Similar Datasets

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