Clinical trial NCT05740332
Conditions: Hand Hygiene Effectiveness
Sponsor: Medline Industries
Start date: 2022-12-12; Completion date: 2023-01-12
Enrollment: 46 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Hand sanitizers are a standard of hygiene requirements. They must be effective at reducing germ count on the hands while ideally providing emollients to moisturize the skin after use. Spectrum™ Advanced Hand Sanitizer Foam (70%) (hereby referred to as Spectrum Advanced Foam) kills over 99.99% of germs within 15 seconds while boasting double digit increases in hand moisture after two weeks of use.

In 2002 and 2009 the Center for Disease Control and Prevention (CDC) and World Health Organization (WHO) published guidance that hands should remain wet for at least 15 seconds while being rubbed together after application of an alcohol-based hand rub, though the recommendations do not specify the volume of product to be apply.

This study will evaluate the "wet time" of Spectrum Advanced Foam, which will be defined as the length of time in which the sanitizer foam stays wet on the hands while the participant rubs their hands with the foam sanitizer. The participant will first be asked to wash and dry their hands. Participants will review the appropriate hand sanitizer application steps, as detailed by the WHO guidance. Then, a 1.0 milliliter (mL) aliquot of Spectrum Advanced Foam will be dispensed from an automated dispenser to the participant's hands. The participant will be asked to rub their hands together following the WHO method for hand sanitizer application until they declare the product has dried sufficiently for the donning of medical gloves. Study personnel will measure the wet time of Spectrum Advanced foam using a stopwatch. If the 1.0 ml aliquot does not yield sufficient results to meet WHO guidelines then a 1.4 ml aliquot will be tested, however this was not the case for our study.

Detailed description:
Hand sanitizers are a standard of hygiene requirements. They must be effective at reducing germ count on the hands while ideally providing emollients to moisturize the skin after use. In 2002 and 2009 the CDC and WHO published guidances that hands should remain wet for at least 15 seconds while being rubbed together after application of an alcohol-based hand rub, though the recommendations do not specify the volume of product to be apply. The CDC specifically recommends applying alcohol-based hand sanitizers by applying the manufacturer-recommended amount of sanitizer directly to the palm of one hand and then rubbing the hands together. The sanitizer must entirely cover the surfaces of both hands and all fingers while rubbing the hands together until the product has dried. The goal of this study is to evaluate the "wet time" of Spectrum Advanced Foam, which will be defined in this study as the length of time in which the foam sanitizer stays wet on the hands while the participant rubs their hands with the foam sanitizer.

Arms: arm 1: 1 mL of alcohol foam hand sanitizer automatically dispensed into hands, spread over hands and rubbed until dry.
Interventions: intervention 1: Alcohol hand sanitizer foam
Intervention descriptions: intervention 1: 1mL of alcohol foam hand sanitizer automatically dispensed into hands, spread over hands and rubbed until dry.

Other Name: Medline Spectrum™ Advanced Hand Sanitizer Foam (70%)

Protocol documents:
Prot_SAP_000.pdf: 
 
 
 
 
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Wet Time for a Foam Hand Sanitizer with 70% ethyl alcohol 
Protocol Number MED-2022-DIV60-002 
 
 
 
18-NOV-2022 
Version 4.0 
 
 
 
 
 
 
Prepared by: 
 
Medline Industries, LP 
Three Lakes Drive 
Northfield, IL 60093  
 
 
 
 
 
 
 
 
Prepared by (Signature) 
 
 
 
 
 
Reviewed by (Signature) 
 
 
Medline Industries, LP 
Three Lakes Drive 
Northfield, IL 60093 
 
 
 
Signature:
Email:
Signature:
Email:


 
 
 
 
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Contents 
DOCUMENT HISTORY .......................................................................................................................... 5 
1. 
PROTOCOL SUMMARY..................................................................................................................... 6 
1.1. 
Synopsis ........................................................................................................................................ 6 
1.1. 
Schedule of Activities (SOA) ....................................................................................................... 9 
2. 
INTRODUCTION ............................................................................................................................... 10 
2.1. 
Background & Rationale ............................................................................................................. 10 
2.2. 
Study Products ............................................................................................................................ 10 
2.3. 
Risk/Benefit Profile .................................................................................................................... 10 
2.3.1. 
Potential Study Risks .......................................................................................................... 10 
2.3.2. 
Potential Study Benefits ...................................................................................................... 10 
2.3.3. 
Assessment of Potential Risk/Benefit Profile ..................................................................... 11 
3. 
OBJECTIVES AND ENDPOINTS ..................................................................................................... 11 
4. 
STUDY DESIGN ................................................................................................................................ 11 
4.1. 
Overall Design ............................................................................................................................ 11 
4.2. 
End of Study Definition .............................................................................................................. 12 
5. 
STUDY POPULATION ...................................................................................................................... 12 
5.1. 
Inclusion Criteria ........................................................................................................................ 12 
5.2. 
Exclusion Criteria ....................................................................................................................... 13 
5.3. 
Strategies for Recruitment and Retention ................................................................................... 13 
6. 
STUDY PROCEDURES AND ASSESSMENTS ............................................................................... 13 
6.1. 
Visit 1 .......................................................................................................................................... 13 
6.1.1. Informed consent and screening ................................................................................................. 13 
6.1.1.1. Informed Consent ........................................................................................................................ 13 
6.1.1.2. Verification and Eligibility ......................................................................................................... 13 
6.1.2. Hand Sanitizer Application ......................................................................................................... 14 


 
 
 
 
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6.1.3. Participant Dismissal .................................................................................................................. 15 
7. 
ADVERSE EVENTS (AEs) ................................................................................................................ 15 
7.1. 
Definition of AE ......................................................................................................................... 15 
7.2. 
Definition of Serious Adverse Event (SAE) ............................................................................... 15 
7.3. 
Severity of AE ............................................................................................................................. 16 
7.4. 
Relatedness of AE and SAE........................................................................................................ 16 
7.5. 
Expectedness ............................................................................................................................... 17 
7.6. 
AE Reporting .............................................................................................................................. 17 
7.7. 
SAE Reporting ............................................................................................................................ 17 
8.       INTERIM ANALYSES .................................................................................................................... 17 
9.      STATISTICAL CONSIDERATIONS ............................................................................................... 18 
9.1.   Sample Size Determination ............................................................................................................ 18 
9.2.   Randomization ................................................................................................................................ 18 
9.3.   Populations for Analyses ................................................................................................................ 18 
a. 
Regulatory and Ethical Considerations ....................................................................................... 20 
i. 
Confidentiality and Privacy ........................................................................................................ 20 
ii. 
Study Discontinuation ................................................................................................................. 20 
iii. 
Data Handling and Record Keeping ........................................................................................... 20 
iv. 
Conflict of Interest Policy ........................................................................................................... 21 
b. 
Protocol Deviations ..................................................................................................................... 21 
c. 
Abbreviations .............................................................................................................................. 21 
11. 
REFERENCES ............................................................................................................................... 22 
12.        APPENDIX……………………………………………………………………….………………23 
 
 
 


 
 
 
 
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INVESTIGATOR ACKNOWLEDGMENT SIGNATURE 
• 
I agree to conduct the study in accordance with the relevant, current protocol and 
will make any changes in the protocol necessary to protect the safety, rights, or 
welfare of participants. 
• 
I agree to personally conduct and supervise the investigation as described within. 
• 
I agree to inform all participants that the device is being used for the purposes of 
an investigational study.  
• 
I will ensure that requirements relating to obtaining informed consent in the 
guidelines for Good Clinical Practices (GCP), and 21 Code of Federal Regulations 
(CFR) Part 50 and Institutional Review Board (IRB) review and approval in 21 
CFR Part 56 are met. 
• 
I agree to report to the IRB and/or Ethics Committee, according to the protocol, 
adverse experiences that occur during the course of the investigation in accordance 
with  guidelines for GCP and 21 CFR 812. 
• 
I have read and understood the information in the protocol, including the potential 
risks. 
• 
I agree to maintain adequate and accurate records in accordance with guidelines for 
GCP and 21 CFR 812.140 and to make those records available for inspection. 
• 
I will ensure that an IRB compliant with the requirements of guidelines for GCP 
and 21 CFR Part 56 will be responsible for the initial and continuing review and 
approval of the clinical investigation. I also agree to promptly report to the IRB all 
changes in the research activity and all unanticipated problems involving risks to 
human participants or others.  
• 
I agree to comply with all other requirements regarding the obligations of clinical 
investigators and all other pertinent requirements in the guidelines for GCP and the 
CFR. 
I have received and reviewed this investigational plan. I will conduct the study as described. 
 
Principal Investigator (Print name): 
Principal Investigator (Signature): 
Date (DD-MMM-YYYY): 




 
 
 
 
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1. PROTOCOL SUMMARY 
1.1. Synopsis  
 
Title: 
Wet Time for a Foam Hand Sanitizer with 70% ethyl alcohol  
 
Study Description: 
Hand sanitizers are a standard of hygiene requirements. They must be 
effective at reducing germ count on the hands while ideally providing 
emollients to moisturize the skin after use. Spectrum™ Advanced Hand 
Sanitizer Foam (70%)  (hereby referred to as Spectrum Advanced Foam) kills 
over 99.99% of germs within 15 seconds while boasting double digit 
increases in hand moisture after two weeks of use. 
 
In 2002 and 2009 the Center for Disease Control and Prevention (CDC) and 
World Health Organization (WHO) published guidance that hands should 
remain wet for at least 15 seconds while being rubbed together after 
application of an alcohol-based hand rub, though the recommendations do 
not specify the volume of product to be apply. 1, 2 
 
This study will evaluate the “wet time” of Spectrum Advanced Foam, which 
will be defined as the length of time in which the sanitizer foam stays wet on 
the hands while the participant rubs their hands with the foam sanitizer. The 
participant will first be asked to wash and dry their hands. Participants will 
review the appropriate hand sanitizer application steps, as detailed by the 
WHO guidance. Then, a 1.0 mL or 1.4 mL* aliquot of Spectrum Advanced 
Foam will be dispensed from an automated dispenser3 to the participant’s 
hands. 1 The participant will be asked to rub their hands together following 
the WHO method for hand sanitizer application until they declare the product 
has dried sufficiently for the donning of medical gloves. Study personnel will 
measure the wet time of Spectrum Advanced foam using a stopwatch.  
 
 
Phase: 
 
Post-market. 
 
* The study is to include an interim analysis of the data after 46 participants have completed the study on the medium 
dispenser setting (1.0 mL). If the results demonstrate a satisfactory 15 second wet time using the medium setting, the 
study will end and no further recruitment will take place. If at this point, the results demonstrate that the amount of 
hand sanitizer dispensed under the medium setting (1.0 mL) does not sufficiently stay wet for at least 15 seconds, a 
second data collection will take place with another 46 participants who will undergo the study using the high dispenser 
setting (1.4 mL). 
 


 
 
 
 
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Primary Objective: 
 
To determine the duration of time during which a 1.0 mL or 1.4 mL* aliquot 
of Spectrum Advanced Hand Sanitizer Foam remains wet under conventional 
use conditions. 
Primary Endpoint: 
The time during which 1.0 mL or 1.4 mL* of Spectrum Advanced Hand 
Sanitizer Foam remains wet under conventional use conditions. 
 
Study Population: 
Number of participants, N = 46. 
 
Inclusion criteria 
Individuals who meet the following criteria will participate in this study: 
➢ Individual  ≥ 18 years of age. 
 
 
Exclusion criteria  
Individuals who meet any of the following criteria will not be allowed to 
participate in this study: 
➢ Individual has a self reported skin condition that might result in 
irritation from the hand sanitizer. 
➢ Individual has a known allergy to the ingredients in the test 
product. 
 
Power Analysis 
Methods: 
The sample size of 46 was estimated for 95% confidence interval based on 
a standard deviation of 5 seconds and target distance from mean to limits of 
1.5 seconds (PASS-Confidence Intervals for One Mean). Results from a 
previous study conducted by Ecolab (summarized in the Appendix) was 
utilized as a starting point for sample size estimation for the current 
protocol, using PASS 2021 Power Analysis and Sample Size Software 
(2021). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass. 
 
Description of 
Sites/Facilities 
Enrolling Participants: 
The study will be conducted at private rooms within the Northfield location 
of Medline Industries, LP.  
 
Address: 
Three Lakes Drive 
 
 
* The study is to include an interim analysis of the data after 46 participants have completed the study on the medium 
dispenser setting (1.0 mL). If the results demonstrate a satisfactory 15 second wet time using the medium setting, the 
study will end and no further recruitment will take place. If at this point, the results demonstrate that the amount of 
hand sanitizer dispensed under the medium setting (1.0 mL) does not sufficiently stay wet for at least 15 seconds, a 
second data collection will take place with another 46 participants who will undergo the study using the high dispenser 
setting (1.4 mL). 
 


 
 
 
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Northfield, IL, 60093 
 
Description of Study 
Design: 
Informed consent will be obtained from participants in-person or remotely. 
Participants will then undergo in-person or remote screening, after which 
participants who meet inclusion criteria will be enrolled in this prospective 
study. The participant will first be asked to wash and dry their hands, and 
wait an additional two minutes after drying their hands. Participants will 
review the steps for applying hand sanitizer, adapted from the WHO 
guidance. 4  The participant will then be asked to apply an aliquot of 
Spectrum Advanced Foam, dispensed from an automatic dispenser (X10 
Dispenser, Medline Industries, LP), to their hands. The participant will be 
instructed to rub their hands together with the sanitizer until their hands are 
dry. Study staff will measure and record the wet time of Spectrum 
Advanced Foam.  
 
 
 
Participant Duration: 
Approximately 30 minutes.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 




 
 
 
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second data collection will take place with another 46 participants who will undergo the study using the high dispenser 
setting (1.4 mL). 
2. INTRODUCTION  
2.1. Background & Rationale 
 
Hand sanitizers are a standard of hygiene requirements. They must be effective at reducing germ count 
on the hands while ideally providing emollients to moisturize the skin after use. In 2002 and 2009 the 
CDC and WHO published guidances that hands should remain wet for at least 15 seconds while being 
rubbed together after application of an alcohol-based hand rub, though the recommendations do not 
specify the volume of product to be apply. 1, 2 
The CDC specifically recommends applying alcohol-based hand sanitizers by applying the 
manufacturer-recommended amount of sanitizer directly to the palm of one hand and then rubbing the 
hands together. The sanitizer must entirely cover the surfaces of both hands and all fingers while 
rubbing the hands together until the product has dried.1 
 
The goal of this study is to evaluate the “wet time” of Spectrum Advanced Foam, which will be defined 
in this study as the length of time in which the foam sanitizer stays wet on the hands while the participant 
rubs their hands with the foam sanitizer. 
2.2. Study Products 
2.2.1. Medline Spectrum™ Advanced Hand Sanitizer Foam (70%)  
Spectrum Advanced Hand Sanitizer Foam  kills over 99.99% of germs within 15 seconds. 
The formula includes added moisturizers to help reduce dry skin. The SKU number for 
Medline Spectrum Advanced Hand Sanitizer Foam  is HH70F1000H.  
 
2.3. Risk/Benefit Profile 
2.3.1. Potential Study Risks 
This study entails minimal risk to the participants. Spectrum Advanced Foam is 
commercially available and widely used in clinical settings. There is the possibility of 
minor skin irritation with the application of Spectrum Advanced Foam, however the 
magnitude of this should be no greater than what occurs through the normal use of the hand 
sanitizers. In addition, the study is designed such that the test product will be applied on 
the non-compromised skin of participants with no self-reported known skin conditions, 
which should impose less risk for study participants. 
2.3.2. Potential Study Benefits 
Direct benefit to the study participants is unlikely. However, the results from this study 
will provide the wet time for Spectrum Advanced Foam, which may better inform product 
efficacy and infection prevention for individuals applying Spectrum Advanced Foam to the 
hands.   




 
 
 
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Informed consent will be obtained either in-person or remotely. Following in-person or remote 
remote participant screening, the participant will be asked to wash and dry their hands and wait an 
additional two minutes. The participants will review the steps for hand sanitizer application, adapted 
from a WHO poster on application of handrubs. The participants will be instructed to apply a 1.0 mL 
or 1.4 mL* aliquot of Spectrum Advanced Foam to their hands. The Spectrum Advanced foam will 
be dispensed from an automated dispenser. The participant will then be asked to rub their hands 
together with the foam sanitizer until their hands are dry, following the WHO recommended method 
for hand sanitizer application. Study staff will use a stopwatch to measure the wet time: the 
application of the product to the palm of the participant will indicate the “start time”, and the 
participant stating that their hands have dried will indicate the “stop time”.  
 
After the participant has indicated that their hands have dried sufficiently for the donning of gloves, 
study staff will record the wet time of Spectrum Advanced Foam. The participant will then be 
dismissed from the study.  
 
 
4.2. End of Study Definition  
A participant will have completed their study participation when all study activities are completed 
at the end of Visit 1.  
This study will be considered complete upon issuance of a Clinical Study Report that has been 
approved by the Clinical Affairs Director.  
5. STUDY POPULATION  
5.1. Inclusion Criteria 
 
 
Individuals who meet the following criteria will participate in this study: 
 
➢ Individual ≥ 18 years of age. 
 
 
 
 
 
 
 
________________________ 
 
* The study is to include an interim analysis of the data after 46 participants have completed the study on the medium 
dispenser setting (1.0 mL). If the results demonstrate a satisfactory 15 second wet time using the medium setting, the 
study will end and no further recruitment will take place. If at this point, the results demonstrate that the amount of 
hand sanitizer dispensed under the medium setting (1.0 mL) does not sufficiently stay wet for at least 15 seconds, a 


 
 
 
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second data collection will take place with another 46 participants who will undergo the study using the high dispenser 
setting (1.4 mL). 
 
5.2. Exclusion Criteria 
  
 
Individuals who meet any of the following criteria will not be allowed to participate in this study: 
 
➢ Individual has a self reported skin condition that might result in irritation from the hand 
sanitizer. 
➢ Individual has a known allergy to the ingredients in the test product. 
 
5.3. Strategies for Recruitment and Retention  
Participants will be recruited from an internal database of Medline employees. Participants will 
have previously participated in studies conducted by Medline, and/or have agreed to be contacted 
for future studies, as well as possibly via IRB-approved advertisement(s). Potential participants 
will be screened and enrolled until a total of 46 participants with complete data are obtained. 
Participants that do not complete study activities will be withdrawn from the study and replaced to 
meet the desired N = 46.  
6. STUDY PROCEDURES AND ASSESSMENTS 
6.1. Visit 1  
6.1.1. Informed consent and screening 
6.1.1.1. 
 Informed Consent 
The study staff will  obtain written informed consent from the participant in-person or over a 
video conference call with the participant. Written consent must be obtained from all 
participants and documented on an Informed Consent form (ICF) that has received  approval 
by an IRB/Ethics Committee. The ICF will be written in adherence to Good Clinical Practice 
(GCP) and must comply with all elements required by United States (U.S.) Food and Drug 
Administration (FDA) 21 CFR 50.25 and International Conference on Harmonization (ICH) 
4.8, state and local regulations, and additional elements relevant to specific study situations 
(including a statement that Medline Industries, LP and relevant authorities have access to 
participant records). A copy of the signed consent will be provided for each participant. 
6.1.1.2. 
Verification and Eligibility 
The PI or delegated study staff will verify the eligibility of the individual for the study, based 
on the inclusion and exclusion criteria that will be evaluated in the Participant Screening Form. 
Participant demographics (age and sex), as well as hand size, will be documented. Study staff 
will verify participant eligibility in the study in-person or over a video conference call with the 


 
 
 
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participant. The participant will receive a unique screening number that will be recorded in the 
Participant Screening Form. The participant responses will be included in the Participant 
Screening Form.  
Successfully enrolled participants will be assigned a unique participant identification number 
based on the order in which they enroll. If the individual is considered eligible to participate in 
the study, the participant will proceed to the study activities detailed in section 6.1.2. 
6.1.2. Hand Sanitizer Application  
 
Participants will first be asked to wash and dry their hands and wait an additional two minutes 
after their hands have dried before application of the hand sanitizer products. Study staff will 
record that the participant has washed their hands and waited an additional two minutes in the 
Case Report Form (CRF). The participants will then review the hand sanitizer application steps 
detailed in Figure 1, which are adapted from the WHO “How to Handrub?” poster. 4 
 
Figure 1. Hand Sanitizer Application Steps (Adapted from the WHO “How to Handrub?” 
Poster)  
 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


 
 
 
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The participants will then be instructed by study staff to apply a 1.0 mL or 1.4 mL* aliquot of  
Spectrum Advanced Foam to their hands, which will be provided from an automated dispenser, 
following the hand sanitizer application steps. Study staff will begin to measure the wet time 
using a calibrated stopwatch: the application of the product to the palm of the participant will 
indicate the “start time”, and the participant stating that their hands have dried will indicate the 
“stop time”.  
 
Once the participant has indicated that their hands are dry enough to don medical gloves, study 
staff  will stop the stopwatch and record the Spectrum Advanced Foam wet time in the CRF.  
 
6.1.3. Participant Dismissal  
After the study staff has recorded the wet time of Spectrum Advanced Foam in the CRF, the 
participant will be dismissed from the study.  
7. ADVERSE EVENTS (AEs)  
7.1. Definition of AE  
The FDA definition for an AE is: An AE is any unfavorable and unintended sign (including an abnormal 
laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or 
procedure that may or may not be considered related to the medical treatment or procedure. 
However, a narrower definition of AE will be used for this study. In this study, an AE is any untoward 
medical occurrence related to the topical use of the hand sanitizers during this study, including skin 
itching, erythema, edema, or any other skin irritation that occurs.  
7.2. Definition of Serious Adverse Event (SAE) 
The FDA definition of a SAE will be used in this study: An AE or suspected adverse reaction is 
considered "serious" if, in the view of the PI it results in any of the following outcomes:  
• 
Death, 
• 
A life-threatening adverse event, 
• 
Inpatient hospitalization or prolongation of existing hospitalization, 
• 
A persistent or significant incapacity or substantial disruption of the ability to conduct 
normal life functions, or 


 
 
 
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_______________________ 
* The study is to include an interim analysis of the data after 46 participants have completed the study on the medium 
dispenser setting (1.0 mL). If the results demonstrate a satisfactory 15 second wet time using the medium setting, the 
study will end and no further recruitment will take place. If at this point, the results demonstrate that the amount of 
hand sanitizer dispensed under the medium setting (1.0 mL) does not sufficiently stay wet for at least 15 seconds, a 
second data collection will take place with another 46 participants who will undergo the study using the high dispenser 
setting (1.4 mL). 
• 
A congenital anomaly/birth defect.  
Important medical events that may not result in death, be life-threatening, or require hospitalization may be 
considered serious when, based upon appropriate medical judgment, they may jeopardize the participant 
and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. 
All SAEs will be reported to Medline, regardless of potential relationship to the study product(s). SAEs 
will be reported to the reviewing IRB as necessary according to their reporting requirements.  
7.3. Severity of AE 
The severity of all AEs will be graded on a scale of one through five according to the Common 
Terminology Criteria for AE guideline, where each grade represents a unique clinical description based 
on this general guideline: 
• 
Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observation 
only; intervention not indicated. 
• 
Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limited age-
appropriate instrumental activities of daily living. 
• 
Grade 3: Severe or medically significant but not immediately life-threatening; 
hospitalization or prolongation of hospitalization indicated; disabling; limiting 
activities of daily living involving self-care.  
• 
Grade 4: Life threatening consequences; urgent intervention indicated 
• 
Grade 5: Death related to AE 
7.4. Relatedness of AE and SAE 
 
• 
Unrelated: This category applies to those AEs which, after careful consideration, are 
clearly and incontrovertibly due to extraneous causes (disease, environment, etc.) 
• 
Possible: This category applies to those AEs for which, after careful medical 
consideration at the time they are evaluated, a connection with the Investigational 
Product administration appears unlikely but cannot be ruled out with certainty. 
• 
Probable: This category applies to those AEs which, after careful medical 
consideration at the time they are evaluated, are felt with a high degree of certainty to 
be related to the study product(s). 
• 
Definite: This category applies to those AEs which, after careful consideration, are 
clearly and incontrovertibly due to the study product(s). 


 
 
 
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7.5. Expectedness 
The PI will be responsible for determining whether an AE or SAE is expected or unexpected. An AE 
will be considered unexpected if the nature, severity, or frequency of the event is not consistent with 
the risk information previously described for the study intervention.  
7.6. AE Reporting 
The AEs will be recorded on the AE form (provided by Medline Industries, LP) by the study staff and 
reviewed by the PI. Changes in the severity of an AE will be documented to allow an assessment of the 
duration of the event at each level of severity. Changes in severity will necessitate a new CRF to 
document the new level of severity. AEs characterized as intermittent require documentation of onset 
and duration of each episode. 
Non-serious AEs will be reported to the IRB per IRB reporting requirements. 
7.7. SAE Reporting 
The PI shall complete an SAE Form (provided by Medline Industries, LP) and will be responsible for 
reporting the event to the IRB, if applicable, per the IRB’s reporting requirements. The PI is responsible 
for conducting an evaluation of the SAE and shall report the results of such evaluation to the FDA and 
to all reviewing IRBs, if applicable, within 10 working days after the PI first receives notice of the 
effect. Thereafter, the PI shall submit such additional reports concerning the effect as FDA requests. 
For questions regarding this process or the event, you may contact your Medline clinical designee or 
the Medline Director of Clinical Operations: 
Name: Greg Gomez, RN, Clinical Affairs Director 
Phone: 224-931-1541 
E-mail: clinicaloperations@medline.com 
8.       INTERIM ANALYSES 
The study is to include an interim analysis of the data after 46 participants have completed the study on 
the medium dispenser setting (1.0 mL). If at this point, the results demonstrate that the amount of hand 
sanitizer dispensed under the medium setting (1.0 mL) does not sufficiently stay wet for at an average of 
at least 15 seconds, a second data collection whereby another 46 participants will undergo the study using 
the high dispenser setting (1.4 mL) will take place. If the results demonstrate a satisfactory average 15 
second wet time using the medium setting (1.0 mL) with 46 participants, the study results will be 
analyzed and it will be decided if an additional study using the 1.4 ml setting is warranted. 


 
 
 
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9.      STATISTICAL CONSIDERATIONS 
9.1.   Sample Size Determination  
The sample size of 46 was estimated for 95% confidence interval based on a standard deviation of 5 seconds 
and target distance from mean to limits of 1.5 seconds (PASS-Confidence Intervals for One Mean). Results 
from a previous study conducted by Ecolab (summarized in the Appendix) was utilized as a starting point 
sample size estimation for the current protocol, using PASS 2021 Power Analysis and Sample Size 
Software (2021). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass. In the event that a participant 
withdraws from the study, additional participants will be enrolled to achieve a final number of 46 
participants with complete data and until adequate power for analysis has been reached. 
                                                                    
9.2.   Randomization 
No randomization is planned at this time. 
9.3.   Populations for Analyses 
The analyses will be performed on the intent to treat (ITT) population which consists of all subjects who 
participated in the study, meaning they have full data on all covariates as well as the hand sanitizer dry 
time.  
No per protocol, safety, or other analyses groups are planned. 
9.4 Protocol Deviations 
The list of protocol deviations will be compiled prior to database lock.  All deviations will be reviewed 
and decisions for handling each of the deviations will be made prior to the start of data analysis. 
9.5. Endpoints  
 9.5.1. Primary Endpoint  
The time during which 1.0 mL of Spectrum Advanced Hand Sanitizer Gel with Aloe Vera and Vitamin E 
remains wet under conventional use conditions. 
  
9.5.2. Secondary Endpoint  
None. 
9.6. Demographics, Variables and Covariates 
 Age will be collected as a continuous measure, with all participants being >=18 years of age.  Age strata 
will be defined as stratum 1: 18-25 years old, stratum 2: 26-41 years old, stratum 3: 42-57 years old, 
stratum 4: 58-67 years old, stratum 5: 68-76 years old, stratum 6: 77-94 years old, 95+ years old.  Age 
will be considered for secondary analysis.      


 
 
 
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Sex will be collected as a categorical equal to 0=male, 1=female, or 2=other.  Sex will be considered for 
secondary analysis. 
  
Hand size will be calculated using the formula 2.48 x hand length x hand breadth as described by 
(Wilkinson et al. (2017), Bellissimo-Rodrigues et al. (2015) and Hsu and Yu (2010)).    
  
 
9.7. Handling of Missing Values 
All missing data will be quantified in the final report and possible biases for any missing data will be 
reported. 
 
9.8. Statistical Analysis 
Statistical analyses will be conducted in SAS® software, Version 9.4 or higher of the SAS System for 
Windows (Copyright © 2013 SAS Institute Inc.) or other appropriate statistical software. P<0.05 will be 
considered statistically significant. 
All continuous variables will be summarized using the following descriptive statistics: (non-missing 
sample size), mean, standard deviation, median, maximum and minimum.  The frequency and percentages 
(based on the non-missing sample size) of observed levels will be reported for all categorical measures.  
95% confidence intervals will be calculated for all means.   
A box-and-whisker plot will be employed to display the mean, interquartile range, range, and any possible 
outliers for wet-to-dry time.    
 Spearman correlation analysis will be used to examine possible associations between the key variable of 
dry time with age, sex, and hand size. Additional t-tests or non-parametric tests will be employed to 
further examine any significant associations found in the correlational analyses between key and covariate 
measures.   
If the results of the interim analysis of 46 participants on the medium dispenser setting (1.0 mL) does not 
demonstrate that hands stay sufficiently stay wet for at an average of at least 15 seconds, a second data 
collection whereby another 46 participants will undergo the study using the high dispenser setting (1.4 
mL) will take place.  All analyses presented above would then be repeated for the data from an additional 
46 participants at the high dispenser setting (1.4 mL).  
 
 


 
 
 
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10. SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS 
a. Regulatory and Ethical Considerations 
i. Confidentiality and Privacy 
Participant confidentiality and privacy is strictly held in trust by the PI and the staff. 
Therefore, documentation, data, and all other information generated will be held in strict 
confidence. No information concerning the study or the data will be released to any 
unauthorized third party without prior written approval of the PI. All study data and study 
records will be managed and stored in accordance with the site’s policies on data storage 
and security. All electronic transmission of data will adhere to Health Insurance Portability 
and Accountability Act (HIPAA) and any local regulations. 
 
Representatives of the IRB, and regulatory agencies may inspect all documents and records 
required to be maintained by the PI, including but not limited to, medical records (office, 
clinic, or hospital) and pharmacy records for the participants in this study. The clinical 
study site will permit access to such records. 
 
A master list linking participant numbers to patient name and medical record number will 
be maintained in a secure database by the PI or paper files in secure cabinet(s). The study 
participant’s contact information will be securely stored at each clinical site for internal 
use during the study. The PI will agree to notify the IRB of any intent to move or destroy 
these documents.  
ii. Study Discontinuation  
This study may be temporarily suspended or prematurely terminated if there is sufficient 
reasonable cause.  Written notification, documenting the reason for study suspension or 
termination, will be provided by the suspending or terminating party to the PI and IRB. If 
the study is prematurely terminated or suspended, the PI will promptly inform the IRB and 
will provide the reason(s) for the termination or suspension.   
Circumstance(s) that may warrant termination or suspension include, but are not limited 
to: 
• 
Determination of unexpected, significant, or unacceptable risk to participants as 
determined by AE review 
The study may resume once concerns about safety, protocol compliance, and data quality 
are addressed, and the IRB is satisfied. 
iii. Data Handling and Record Keeping 
Data collection is the responsibility of the study staff at the site under the supervision of 
the PI. The PI is responsible for ensuring the accuracy, completeness, legibility, and 
timeliness of the data reported in the CRFs or any other study activity documentation as 


 
 
 
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part of this study. All the documents should be completed in accordance with Good 
Documentation Practices (GDP) to ensure accurate interpretation of data.   
Final storage of Medline data will be per ICH/GCP guidelines and kept stored in a protected 
access area for the length of the time required. 
iv. Conflict of Interest Policy 
The independence of this study from any actual or perceived influence is critical. 
Therefore, any actual conflict of interest of persons who have a role in the design, conduct, 
analysis, publication, or any aspect of this trial will be disclosed and managed. 
b. Protocol Deviations 
It is the responsibility of the PI and study staff to use continuous vigilance to identify and report 
deviations on a routine basis. All deviations must be addressed in the study source documents, and 
reported to Medline Industries, LP. Protocol deviations must be sent to the reviewing IRB per 
reporting requirements in a timely manner. The PI is responsible for knowing and adhering to the 
reviewing IRB requirements. 
c. Abbreviations 
 
AE 
Adverse Event 
CDC  
Centers for Disease Control and Prevention  
CFR 
Code of Federal Regulations 
CRA 
Clinical Research Associate 
CRF 
Case Report Form 
CRO 
Contract Research Organization 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 
GDP 
Good Documentation Practice 
HIPAA 
Health Insurance Portability and Accountability Act 
ICH 
International Conference on Harmonization 
IRB 
Institutional Review Board 
PI 
Principal Investigator 


 
 
 
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SAE 
Serious Adverse Events 
SOA 
Schedule of Activities 
U.S. 
United States 
WHO 
World Health Organization  
 
11.  REFERENCES 
1. Centers for Disease Control and Prevention. Guideline for Hand Hygiene in Health-Care Settings: 
Recommendations of the Healthcare Infection Control Practices Advisory Committee and the 
HICPAC/SHEA/APIC/IDSA Hand Hygiene Task Force. MMWR 2002;51(No. RR- 16): 11, 13. 
2. World Health Organization (WHO). WHO Guidelines on Hand Hygiene in Health Care. Geneva: 
WHO, 2009. 
3. PRODISPAB, Soap: HHSP1000FM, either table top (HHTABLESTAND) or floor stand 
(HHSTANDWH). 
4. How to Handrub? World Health Organization; 2009. https://cdn.who.int/media/docs/default-
source/integrated-health-services-(ihs)/infection-prevention-and-control/how-to-handrub-
poster.pdf?sfvrsn=f5e8bfb1_6 
 
 
 
 
 
 
 
 
 
 
 


 
 
 
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12. APPENDIX  
 
a. Hand Sanitizer Product Ingredients 
 
 
i. Spectrum™ Advanced Hand Sanitizer Foam  
 
 
Ingredients (Active): 70% v/v Ethyl Alcohol 
Ingredients (Inactive): (Alphabetical) denatonium benzoate, Glycerin, Glyceryl caprylate, 
Isopropyl myristate, PEG-12 dimethicone, t-butyl alcohol, Water