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

Abstract

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.