Follow-up telephone surveys were available for 99% (168/170) on Day 1, 99% (168/170) on Day 5, and 94% (160/170) on Day 14 postvaccination Where delivery or performance dates are stated by VWR these are estimates only and time is not of the essence; however, if VWR needs to change such dates it will do so only after providing information to the customer and having regards to the customer’s stated objectives.

Any additional or special terms included by VWR in its written acceptance shall form part of the contract. The terms and conditions of the contract apply equally to the supply of both products and services except where application to one or the other is specified. While care has been taken to ensure that the information prepared by CADTH in this document is accurate, complete, and up-to-date as at the applicable date the material was first published by CADTH, CADTH does not make any guarantees to that effect. CADTH does not guarantee and is not responsible for the quality, currency, propriety, accuracy, or reasonableness of any statements, information, or conclusions contained in any third-party materials used in preparing this document. The views and opinions of third parties published in this document do not necessarily state or reflect those of CADTH.Various health organizations including the WHO, United Kingdom’s Department of Health, and Australia’s Department of Health have stated that if the skin is visibly clean, disinfecting the skin (or alcohol swabbing) is not necessary and does not reduce infection. To the contrary, the Public Health Agency of Canada advises the practice of cleaning the skin with a suitable antiseptic solution prior to vaccination or injection. Hence, there is ongoing debate whether the continued use of alcohol swabbing is clinically necessary and effective for routine injections or vaccinations.

The purpose of this report is to summarize the evidence regarding the clinical effectiveness and cost-effectiveness of skin preparation prior to injections. Evidence-based guidelines regarding preparing the skin for injection will also be sought. The customer is required to ensure that the use of any products supplied by VWR does not infringe the intellectual property rights of any third party and the customer shall indemnify VWR against any claims made against VWR by any third party in relation to any such infringement or alleged infringement. Additionally, the study was described as being partially blinded with the all participants, parents and pediatricians (administering the injections) being blinded, though the clinic-based research assistant who performed the skin preparation for both intervention and control groups was not blinded. The choice of unblinding the clinic-based research assistant who performed skin preparation was considered justifiable as it may not have been possible to blind the individual performing this task. As this was the only unblinded person in this study, the risk of bias was. Nevertheless, the same clinic-based research assistant who performed the skin preparation also interviewed the parents post-vaccination for the results. This may bias the study results as the clinic-based research assistant’s knowledge of treatment group allocation for each patient may have affected the reporting of results. Additionally, the randomization and allocation were clearly defined in the study protocol and both groups were followed up for the same amount of time. This reduces selection bias and the influence of confounding variables in the study and strengthens the internal validity (the extent to which the study supports a claim about cause and effect) of the study. 8 Nothing in this contract shall limit or exclude VWR’s liability for death or personal injury caused by its negligence, fraud, fraudulent misrepresentation, or any other matter in respect of which it would be unlawful for VWR to exclude or restrict liability. Subject to this, in view of the responsibilities of the customer set out in the above paragraphs:

This is the first RCT to specifically examine the effect of alcohol swab skin cleansing on the incidence of local skin reactions and infection in children undergoing vaccine injections. We found no evidence of a difference in the rate of local skin reactions and no cases of cellulitis or infectious abscess when alcohol swabs were and were not used” (pp997) VWR may at any time, without limiting any other rights and remedies that it may have, set off any amount owing to it by the customer under the contract against any amount payable by VWR to the customer (whether under the contract or a separate agreement). Delivery Inclusion criteria: Healthy children aged zero to 18 years who qualified for vaccination in accordance with the Ontario Immunization Schedule were eligible. The customer shall cooperate with VWR in all matters relating to the services, provide all such access and information as is necessary and obtain any licences permissions and consents required before commencement of the services.

Authorisation for the return of products which fail to meet current published manufacturer’s specifications must be requested in writing within 28 days of delivery. VWR will assist customers, at customers’ expense, to obtain any manufacturer’s warranty consistent with that granted to VWR. One randomized controlled trial was included in this report comparing skin preparation to no skin preparation prior to injection. No relevant cost-effectiveness studies or evidence-based guidelines were identified regarding preparing the skin for injection. Exclusion criteria: Children were excluded if a parent was not fluent in English or was unavailable for the 15 days post vaccination follow-up period, previously participated in the study, documented allergy to isopropyl alcohol, taking antibiotics or had a contraindication to vaccination. These terms and conditions cover all sales of products and services by VWR International Ltd (VWR) in the United Kingdom and any information and advice given whether charged for or not, unless otherwise agreed by VWR in writing. These terms and conditions apply to the exclusion of any other terms submitted by the customer or which are implied by any trade, custom, practice or course of dealing. Customer AccountsAuthorisation to return products damaged during delivery must be requested within 3 days of delivery. VWR has the right to repair and return damaged products. Any liability accepted by VWR under this contract is in lieu of any terms implied by law as to the quality or fitness for any particular purpose of the products and/or the standard of the services and all such implied terms are, to the fullest extent permitted by law, excluded from the contract between VWR and the customer. The customer shall indemnify VWR against any claims made against VWR by the customer’s employees, contractors or agents. Intellectual property rights the total liability of VWR for any loss or damage suffered by a customer in connection with the supply of the products under this contract is limited to the invoice price of the products in relation to which loss or damage is claimed. If VWR’s performance of the services is prevented or delayed by any act or omission of the customer, VWR shall without limiting its other rights or remedies, have the right to suspend performance of the services until the customer remedies the position and VWR shall not be liable for any losses or costs arising from such delay. Health, Safety and Liability VWR shall provide services to the customer in accordance with the specification agreed between them from time to time. Such services will be provided with all reasonable care and skill.

This document is prepared and intended for use in the context of the Canadian health care system. The use of this document outside of Canada is done so at the user’s own risk. Evidence from the randomized-controlled trial suggested that alcohol swabbing does not reduce local skin reactions prior to vaccination. The study had reasonable attempts at blinding where possible and described the main outcomes, recruitment process and overall results. There were no statistically significant differences between the alcohol swab group and control group for delayed pain, redness, swelling and warmth to touch while there were no reported cases of cellulitis and infectious abscesses. Post-hoc analysis showed that the duration of pain was statistically significantly higher in the alcohol swab group compared to the control group although the clinical significance of this outcome not discussed by the authors. The study was underpowered to detect differences in the primary outcome of skin infection and instead focused on the differences of local skin reaction between groups. Therefore, the study did not answer the primary outcome and a larger sample size is needed to detect whether alcohol swabbing does reduce the risk of infection. While the authors report that this is one of the first studies to report on the effectiveness of alcohol swabbing prior to vaccinations, it is difficult to draw definitive conclusions from a single trial. 8 Subject to the aforementioned limitations, the views expressed herein are those of CADTH and do not necessarily represent the views of Canada’s federal, provincial, or territorial governments or any third party supplier of information. The reporting of the RCT was considered well done overall, with a clear description of the objective, patient eligibility criteria, inventions and controls. The outcomes were described; however, most of the outcomes were reported by the parents of the patients (except cellulitis and infectious abscesses which were diagnosed by a pediatrician) rather than an objective assessment of the outcome by a health professional. This subjective approach to reporting outcomes may bias the outcomes; though the authors noted that this would not introduce differential reporting between groups. As patients and the parents were blinded to the treatment group, they would unlikely be influenced differently between groups in their outcome reporting (i.e., the assessment of outcomes is equally flawed across groups). The study reported that approximately 20% of diaries were not returned by parents which may impact the validity and interpretation of results. Furthermore, the authors undertook a post-hoc analysis for both groups regarding the duration of local skin reaction and this analysis was considered justifiable as this outcome was unspecified before the data was seen. 8 On termination of the contract for any reason the customer shall immediately pay to VWR all of its outstanding unpaid invoices and interest. ConfidentialityCustomers who exceed their credit limits will be asked to pay in advance for additional products and/or services until the account is settled. Authorisation will be subject to the condition that the products are returned to VWR Customer Service Centre or to the manufacturer or other source and by the method advised by VWR.