A Clinical Evaluation of a Manuka-Honey Impregnated Dressing at Removing Necrotic Tissue From Chronic Foot and Ankle Wounds
Phase: NA
Conditions: Wound Heal, Necrotic Tissue Removal
Sponsor: Medline Industries

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Protocol Number R16-017 
 
A Clinical Evaluation of a Manuka-Honey Impregnated Dressing at 
Removing Necrotic Tissue from Chronic Foot and Ankle Wounds 
 
October 17, 2018 
 
 
Prepared by: 
 
Medline Industries 
Three Lakes Drive 
Northfield, IL 60093  
 
 
 
 
 
 
 
Prepared by (Signature) 
 
Date 
Reviewed by (Signature) 
 
Date 
Medline Industries, Inc. 
Three Lakes Drive 
Northfield, IL 60093 
 
 
 
Digitally signed by ejones@medline.com 
DN: cn=ejones@medline.com 
Date: 2018.10.23 08:54:33 -05'00'
William 
Jacobson
Digitally signed by William Jacobson 
DN: cn=William Jacobson, o=Director, 
CLinical Affairs, ou=Medline Medical 
Affairs, 
email=wijacobson@medline.com, c=US 
Date: 2018.10.24 08:53:10 -05'00'

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PRINCIPAL INVESTIGATOR ACKNOWLEDGMENT SIGNATURE 
 
 
I agree to conduct the study in accordance with the relevant, current protocol and will make 
changes in the protocol only after notifying the Sponsor, except when necessary to protect the 
safety, rights, or welfare of subjects. 
 
I agree to personally conduct and supervise the investigation as described within. 
 
I agree to inform all subjects 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, and 21 CFR Part 50 and institutional review board (IRB) review and approval 
in 21 CFR Part 56 are met. 
 
I agree to report to the Sponsor, IRB and/or Ethics Committee, according to the protocol, adverse 
experiences that occur during the course of the investigation in accordance with  guidelines for 
Good Clinical Practices, and 21 CFR 812. 
 
I have read and understand the information in the protocol, including the potential risks. 
 
I agree to maintain adequate and accurate records in accordance with guidelines for Good Clinical 
Practices 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 Good Clinical 
Practices 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 subjects 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 Good Clinical Practices, and the Code of 
Federal Regulations. 
I have received and reviewed this Investigational Plan. I will conduct the study as described. 
 
 
 
 
 
 
 
 
 
 
__________________________________________     
_______________________ 
 
 
Principal Investigator’s Signature  
 
 
Date 
 
 
 
 
 
 
 

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DOCUMENT HISTORY 
 
VERSION 
DATE 
DESCRIPTION 
Version 1.0 
05-Dec-2017 
Initial Protocol 
Version 2.0 
17-Oct-2018 
Amendments to study personnel, study 
equipment, adverse event reporting, and 
sample size 
 
 

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TABLE OF CONTENTS 
1. 
STUDY TEAM ..................................................................................................................................... 7 
2. 
INTRODUCTION ................................................................................................................................ 8 
2.1. BACKGROUND AND RATIONALE ................................................................................................. 8 
2.2. INVESTIGATIONAL PRODUCT: THERAHONEY® FOAM FLEX ................................................ 8 
2.3  
STUDY POPULATION AND DURATION ..................................... 8 
2.4  
STUDY RISKS AND BENEFITS ............................................ 9 
3. 
STUDY OBJECTIVES......................................................................................................................... 9 
3.1. PRIMARY OBJECTIVE ...................................................................................................................... 9 
3.2. SECONDARY OBJECTIVES ............................................................................................................. 9 
4. 
STUDY DESIGN ................................................................................................................................. 9 
4.1. 
DESIGN ............................................................ 9 
4.2. 
SUBJECT SELECTION .................................................. 9 
4.2.1. 
Inclusion Criteria................................................................................................................... 9 
4.2.2. 
Exclusion Criteria ............................................................................................................... 10 
5. 
STUDY PROCEDURES .................................................................................................................... 11 
5.1. 
RECRUITMENT ...................................................... 11 
5.2. 
SCREENING VISIT (DAY 0) .............................................. 11 
5.2.1. 
Informed Consent ...................................................... 11 
5.2.2. 
Demographics ..................................................................................................................... 11 
5.2.3. 
Medical History and Concomitant Medication ................................................................... 11 
5.2.4. 
Vascular Ankle Assessment ................................................................................................ 12 
5.2.5. 
Diabetic Assessments .......................................................................................................... 12 
5.2.6. 
Wound Screening Evaluation .......................................................................................... 12 
5.2.7. 
Confirmation of Eligibility .................................................................................................. 12 

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5.3. 
INITIAL VISIT (DAY 1) AND WEEKLY INTERIM VISITS........................ 13 
5.3.1. 
Wound Evaluation............................................................................................................... 13 
5.3.2. 
Photographing the Wound .................................................................................................. 13 
5.3.3. 
Secondary Dressing Notation .............................................................................................. 14 
5.3.4. 
Debridement ........................................................................................................................ 14 
5.3.5. 
TheraHoney® Foam Flex Application ................................................................................. 14 
5.4. 
FINAL VISIT ......................................................... 14 
5.4.1. 
Data collection ................................................................................................................... 14 
5.4.2. 
Physician Questionnaire ...................................................................................................... 14 
6. 
CLINICAL SUPPLIES AND PRODUCT AVAILABILITY ............................................................ 16 
7. 
ADVERSE EVENTS .......................................................................................................................... 16 
7.1. 
Adverse Event Reporting ........................................................................................................ 16 
7.2. 
Serious Adverse Event Reporting ........................................................................................... 17 
7.3. 
Unanticipated Adverse Event Reporting ................................................................................. 18 
8. 
DATA MONITORING AND STATISTICS ...................................................................................... 18 
8.1. 
DATA COLLECTION .................................................. 18 
8.2. 
SAMPLE SIZE JUSTIFICATION ........................................... 19 
8.3. 
ANALYSIS OF EFFICACY DATA ......................................... 19 
8.3.1. 
Primary Endpoint ................................................................................................................ 19 
8.3.2. 
Secondary Endpoints ........................................................................................................ 19 
8.3.3. 
Evaluable Dataset .............................................................................................................. 20 
8.4 
ANALYSIS OF SAFETY DATA ............................................. 20 
9. 
REFERENCES ................................................................................................................................... 20 
10. APPENDICES .................................................................................................................................... 21 
10.1 APPENDIX A: Therahoney® Product Labeling ...................................... 22 

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10.2  APPENDIX B: Subject Eligibility Questionnaire..................................... 24 
10.3 
APPENDIX C: Bates-Jenson Wound Assessment Scale ............................ 26 
10.4 APPENDIX D: Case Report Form ............................................... 30 
10.6 
APPENDIX F: Adverse Event (AE) Report Form ................................ 33 
10.7 APPENDIX G: Serious Adverse Event (SAE) Report Form .............................. 34 
 
 
 
 

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1. 
STUDY TEAM 
 
Principal Investigator 
 
 
Dr. Patrick McEneaney 
Doctor of Podiatric Medicine 
Northern Illinois Foot & Ankle Specialists 
165 N. Lakewood, Suite A 
Lake in the Hills, IL 60156  
113 W. Main Street 
Cary, IL 60013 
Office: 847-639-5800  
drmceneaney@illinoisfoot.com 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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2. 
INTRODUCTION 
2.1. 
BACKGROUND AND RATIONALE 
Wound healing is known to be assisted by the removal of necrotic tissue.1 Healing of 
these wounds may not occur at an optimal rate due to the presence of such necrotic tissue. 
Honey has been known to be an important adjunctive therapy in the field of wound care 
for centuries.2,3 Honey impregnated wound dressings serve as autolytic debridement 
agents that promote removal of necrotic tissue from wounds, while maintaining a moist 
healing environment in subjects with chronic wounds. 
The purpose of this study is to evaluate the effectiveness of a honey-impregnated wound 
dressing (TheraHoney® Foam Flex, Medline Industries, Inc.) at removing necrotic tissue 
in subjects with chronic foot or ankle wounds. The study will also evaluate the ability to   
promote granulation and re-epithelialization when using this type of dressing, as well as 
collect safety and ease of use data on the product. 
2.2. 
INVESTIGATIONAL PRODUCT: THERAHONEY® FOAM FLEX 
The investigational product being examined, TheraHoney® Foam Flex, contains 100% 
Manuka honey and is ideal for difficult to dress wounds. The dressing provides a moist 
wound environment to help promote autolytic debridement. TheraHoney® Foam Flex is 
ideal for partial or full thickness wounds with moderate-to-heavy drainage. The honey in 
the product is carefully filtered, irradiated, and tested in a laboratory.  
Suitable secondary dressings are indicated for use when necessary. Contraindications include 
third-degree burns and lesions with active vasculitis. More information on the product, 
including labeling, is provided in Appendix A. 
 
2.3  
STUDY POPULATION AND DURATION 
 
Participants in this study will be patients with chronic foot or ankle wounds who are 
under the care of a physician (the Principal Investigator or a Co-Investigator; collectively 
an “Investigator” or “the Investigators”). Further information on study population can be 
found in section 4.2. Following initial screening, this study protocol calls for a 4-week 
period that encompasses initial application of wound dressing, weekly follow-up visits, 
and a final assessment at approximately 4 weeks. In the event a patient’s wound heals 
sooner than 4-weeks and he/she no longer needs medical care, all necessary data to 
complete the study will be collected at the visit where an Investigator deems the patient 
to be healed, and he/she will not continue through 4-weeks. Therefore, study duration 
period may vary based on individual wound response and discretion of an Investigator, 
but will not exceed 4-weeks plus screening time.  
 
 

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2.4  
STUDY RISKS AND BENEFITS 
This study presents minimal risk to the participant sample, given that this is a currently 
marketed medical device with FDA cleared 510(k) pre-market submission that will be 
used in accordance with the product’s labeling. Participants may experience some 
discomfort when applying or removing the dressing, but this should be minimal and not 
exceed what they would feel through the normal use of the product. Participants may 
directly benefit from their participation in this study, as the TheraHoney® Foam Flex 
dressing may provide better debridement and healing of their wound than their previous 
therapies, though this is not guaranteed and a comparison to other therapies is not part of 
this study’s scope. Participation in this study may allow for scientists and healthcare 
professionals to better understand the clinical utility of honey impregnated dressings, 
thereby informing future clinical practice.  
3. 
STUDY OBJECTIVES 
3.1. 
PRIMARY OBJECTIVE 
To evaluate the ability of TheraHoney® Foam Flex wound dressing to remove necrotic 
tissue in patients with chronic foot or ankle wounds.   
 
3.2. 
SECONDARY OBJECTIVES 
To evaluate the efficacy of TheraHoney® Foam Flex in the promotion of granulation and 
re-epithelialization in chronic wounds. 
To evaluate the safety and ease of use of TheraHoney® Foam Flex when applied to 
chronic wounds. 
 
4. 
STUDY DESIGN 
4.1. 
DESIGN 
A single-center, open-label, observational study involving 20 evaluable subjects with 
qualified chronic foot or ankle wounds (as judged by an Investigator, in reference to the 
product labeling and inclusion criteria listed below) on which treatment with 
Therahoney® Foam Flex will be administered in order to evaluate product efficacy, 
safety, and ease of use.  
 
4.2. 
SUBJECT SELECTION 
4.2.1. Inclusion Criteria 
Subjects MUST MEET ALL of the following criteria prior to enrollment: 

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 Male or female ≥18 years of age 
 Written consent must be obtained from the subject and/or their legally-
authorized representative.  
 Subject has a qualified chronic foot or ankle wound, sized 1 cm2 to 25 
cm2, for ≥ 4 weeks in duration. 
 Must have necrotic tissue at least 20% of wound area 
 The wound type matches one of the indicated wounds listed on the product 
labeling:  
 Leg ulcers 
 Pressure ulcers 
 Diabetic foot ulcers 
 First and second degree burns 
 Surgical wounds 
 Trauma wounds 
 
 Subject has adequate circulation as demonstrated by biphasic or triphasic 
Doppler waveform, consistent with adequate blood flow, within 3 months 
prior to study enrollment. If monophasic on exam, then non-invasive tests 
must display Ankle Brachial Index over 0.8 and no worse than mild disease 
on segmental pressures. 
 
Subject is likely to be compliant with instructions for care, such as 
following institutional standard of care directions, offloading, and keeping 
the wound area protected from environmental contaminants 
 Type I/II diabetic subjects that meet the following criteria: 
 Random blood glucose is less than 450 mg/dL within 30 days of the 
screening visit  
4.2.2. Exclusion Criteria 
Subjects MUST NOT MEET ANY of the following criteria prior to 
enrollment: 
 Subject has a known sensitivity or allergy to honey based products, bee 
venom, or other ingredients in product 
 The subject is breastfeeding, pregnant, or has intentions of becoming 
pregnant during the course of their study participation. 
 
Wound duration ≥ 52 weeks 

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 The subject has a prognosis that indicates unlikely survival past the study 
period. 
 The subject is currently receiving dialysis. 
 
Gangrene is present in the target wound. 
 
Patient’s wound is infected 
 The subject’s diagnosis indicates third degree burns. 
 
The subject has received any treatment prior to study enrollment that may, in the 
opinion of an Investigator, affect the outcome of the study. 
 
In the opinion of an Investigator, the subject is otherwise not suitable for study 
participation, such as the subject is likely to be non-compliant with study 
requirements. 
5. 
STUDY PROCEDURES 
5.1. RECRUITMENT 
Subjects will be recruited from the Northern Illinois Foot and Ankle practice of the 
Principal Investigator (PI) or co-Investigators. All interested subjects will undergo 
informed consent and screening to ensure they meet the inclusion/exclusion criteria 
listed in Sections 4.2.1 and 4.2.2 of this protocol.  
5.2. SCREENING VISIT (DAY 0) 
5.2.1. Informed Consent 
Written consent must be obtained from all participating subjects and documented on an 
informed consent form (ICF) that has received approved by an IRB/Ethics Committee. 
The ICF must be written in adherence to Good Clinical Practice (GCP) and comply with 
all elements required by FDA CFR 50.25 and ICH 4.8, state and local regulations, and 
additional elements relevant to specific study situations, (including a statement that 
Medline Industries, Inc. and authorities have access to subject records). 
5.2.2. Demographics 
Subject age, gender, and race will be captured.  
5.2.3. Medical History and Concomitant Medication 
During initial consideration to determine eligibility, a generalized medical history 
must be obtained from the subject in order to determine whether any previous or 
current co-morbidities, chronic wounds (if known) and/or treatments that may, in 
the opinion of an Investigator, adversely affect subject safety and/or the outcome 
of study data (reference exclusion criteria listed in section 4.2.2.). 

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A record of relevant medications (prescription and over the counter) that are 
administered to the subject throughout the duration of their study participation 
should be noted, such as antibiotic use and any ongoing adjunct wound therapies. 
Careful consideration should be made to investigate and document medication use 
that may be related to Adverse Event occurrences. Additional information 
regarding Adverse Event reporting may be found in Section 7. 
5.2.4. Vascular Ankle Assessment 
Doppler Ultrasound (biphasic or triphasic wave form) will be used to assess 
vascular supply. In the event the potential subject does not have a reading within 
the past 90 days prior to the screening visit, the assessment will take place at the 
screening visit using a SONOTRAX Basic ultrasonic pocket Doppler by Edan 
Industries Inc. If exam result is monophasic, subject can still be enrolled in study 
if non-invasive tests display an Ankle Brachial Index over 0.8 and no worse than 
mild disease on segmental pressures.  
5.2.5. Diabetic Assessments 
Subjects with diabetes (type I or II) will be allowed to participate in the study, 
provided that their glucose level results are less than 450 mg/dL. In the event the 
potential subject does not have a blood glucose reading within the past 30 days, a 
measurement will be conducted at the screening visit using an EVENCARE G3 
blood glucose monitoring system. 
5.2.6. Wound Screening Evaluation 
The type of wound will be diagnosed and receive a diagnostic code based on type 
of wound at initial presentation (e.g., venous, diabetic, pressure, etc.). A history of 
the wound will be collected to determine that it has been present for greater than 
four weeks, but less than 52 weeks. Further, every attempt should be made to 
document the types of dressings previously used in the treatment of the wound in 
question, up to six months prior to enrollment. An image of the wound will be 
taken with the eKare inSight® wound assessment camera, which will calculate 
wound size and tissue composition of the wound. The Investigator will analyze 
the wound and the image of the wound to confirm wound size and percent 
necrotic tissue in order to verify the wound meets the inclusion criteria stated 
above.  
5.2.7. Confirmation of Eligibility 
The subject is confirmed as meeting all required inclusion criteria, as listed in 
section 4.2.1. 
The subject is confirmed as not meeting any of the exclusion criteria, as listed in 
section 4.2.2. 

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5.3. INITIAL VISIT (DAY 1) AND WEEKLY INTERIM VISITS 
Please note that the Initial Visit (Day 1) may be combined with the Screening Visit (Day 
0) for pragmatic purposes. In the event this occurs, all Screening Visit activities will 
precede any Initial Visit activities.  
5.3.1. Wound Evaluation 
Wound evaluation for data collection purposes will begin at the initial visit and 
thereafter during each visit at the outpatient centers where this study is going to be 
conducted.   Wound Evaluation will include the following parameters (please also 
see sample Case Report Form (CRF) in Appendix D which will be used at each 
visit): 
 
Wound size ( length, width and depth)  
 
Evaluation of Odor.  Investigator assessment of wound odor will 
be captured via a 4-point categorical scale after each application. 
 
Percent of Necrotic Tissue. The percent of necrotic tissue will be 
assessed based on photos taken of the wound with eKare inSight® 
and visual confirmation from the Investigator to determine the 
percent covered with the necrotic tissue versus the total area of the 
wound. This will be entered in question six of the Bates-Jensen 
Wound Assessment Tool, as described in Appendix C.   
 
Pain Assessments.  Pain will be assessed by the subject after the 
application (or re-application, for interim visits) of the dressing. 
Pain will be based on a 10-point Pain Score.  
 
Site Infections.  Any infections at the wound site will be 
documented. In the event a participant develops an infection 
his/her participation in the study will discontinue, and the 
physician will implement appropriate treatment measurements. 
 
Bates-Jensen Wound Assessment Tool (BWAT). The BWAT will 
be administered to further characterize the wound. Please see 
Appendix C for BWAT. 
5.3.2. Photographing the Wound 
In order to obtain an accurate assessment of the wound, photographs of the wound 
and surrounding skin must be obtained using the eKare inSight® wound 
assessment camera. Photographs taken with the eKare device will include a 
visible label containing the following information subject number and date. 

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5.3.3. Secondary Dressing Notation 
All wounds following treatment will be covered with a suitable secondary 
dressing where Investigators judge that a wound dressing with debridement or 
moisture control will be appropriate. The secondary dressings used will be noted 
during each visit. Medline Industries, Inc. will provide Optifoam® Gentle Super 
Absorbent silicone dressings for use as secondary dressings.   
5.3.4. Debridement  
Mechanical debridement should only be performed per normal standard of care. If 
mechanical debridement occurs at a visit, it will be noted on the CRF.  
5.3.5. TheraHoney® Foam Flex Application 
The application of TheraHoney® Foam Flex will be performed according to the 
product labeling during the Initial Visit (Day 1) and subsequent Interim Visits. 
Dressing changes will take place daily, with the Investigator instructing 
participants on how to change the dressing at home on days when they do not visit 
the clinic. The use of secondary dressings will also be done at the discretion of an 
Investigator. At the discretion of an Investigator, use of TheraHoney®   Foam Flex 
should be discontinued due to adverse events or lack of wound closure response. 
5.4. FINAL VISIT 
The Final Visit will be scheduled to take place approximately 4 weeks following the Initial 
Visit. In the event that during a weekly Interim Visit, an Investigator judges the wound to 
be 100% healed and medical care is no longer necessary, that Interim Visit will be deemed 
the Final Visit.  
5.4.1. Data collection  
All activities listed in section 5.3.1 and 5.3.2 will take place in the Final Visit in order   
to complete data collection. Notations on dressings and debridement will not be 
documented at this visit, though they may of course occur based on an Investigator’s 
judgment. 
5.4.2. Physician Questionnaire 
Product ease of use will be evaluated using on the Investigator Questionnaire 
(Appendix E) at the end of subject’s study participation. 
 
 
 

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TABLE 5.1 TIME AND EVENTS SCHEDULE 
 
REQUIRED ASSESSMENTS 
SCREENING 
VISIT 
Day 0 
 (May be combined 
with first interim 
visit, Day 1) 
INITIAL VISIT  
Day 1 
 
INTERIM 
VISITS 
Approx. Every 7 
Days 
 
 
FINAL VISIT5 
 
Approx. 28 days after 
Day 1 visit 
Informed Consent 
X 
 
 
 
 
Demographics  
X 
 
 
 
Medical History 
X 
 
 
 
Concomitant Medication 
X 
 
 
 
Physical Examination 
X 
 
 
 
Doppler Assessment 
X1,3 
 
 
 
Blood Glucose 
Assessment   
X1, 2, 4 
 
 
 
Wound Screening 
Evaluation 
X 
 
 
 
Confirmation of 
Eligibility 
X 
X 
X 
 
 
Adverse Event 
Assessment 
X 
X 
X 
X 
Wound Evaluation 
 
X 
X 
X 
Wound Photograph 
 
X 
X 
X 
TheraHoney® Foam 
Flex  
 
X 
X 
 
Secondary Dressing 
Notation 
 
X1 
X1 
 
Mechanical debridement 
noted 
 
X1 
X1 
 
 
Investigator 
Questionnaire 
 
 
 
X 
 
1 If required  
2 Within 30 days of screening visit or at screening visit 
3 Within 90 days of screening visit or at screening visit 
4 Diabetic subjects only 
5 Final visit may be an interim visit in the event patient heals fully before 4 weeks and no longer requires treatment 
 
 

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6. 
CLINICAL SUPPLIES AND PRODUCT AVAILABILITY 
Medline Industries, Inc. will provide the Investigators with supplies of TheraHoney® 
Foam Flex dressings and Optifoam® Gentle Super Absorbent silicone dressings (to be 
used as a secondary dressing if required) for the duration of the study.  
Storage conditions for these materials will be maintained in accordance with the 
guidelines set forth in the product labeling. A record of the study-related materials 
supplied by the Sponsor, Medline Industries Inc., will be maintained by the Investigators 
at both clinic locations. Dispensing of these supplies will also be noted.  
All unused investigation product will be disposed of properly by the investigational site, 
in accordance with their standard destruction procedures. 
Medline Industries, Inc. will provide the eKare inSight® wound assessment camera, the 
ultrasonic pocket Doppler (SONOTRAX Basic), and glucose monitor (EVENCARE G3) 
for the period of the study. This equipment is to be stored securely throughout the study 
and will be returned to Medline Industries, Inc. upon completion of the study.  
7. 
ADVERSE EVENTS 
All Adverse Events (AE) are defined as set forth in the International Conference on 
Harmonization (ICH) Guideline for Clinical Safety Data Management: Definitions and 
Standards for expedited Reporting E2A (R1) and the Food and Drug Administration 
Code of Federal Regulations Title 21, part 812, as appropriate. 
AEs will be collected throughout the study and documented in the subject’s medical 
record and on the appropriate AE form. 
All events will be followed until the event has been resolved or, in the case of permanent 
impairment, until the event stabilizes. 
Information regarding any AEs occurring during the study will be recorded on the 
appropriate AE form. Such information will include, at a minimum, the date of the event, 
severity, outcome, and the relation (if any) to the investigational product. 
7.1. 
Adverse Event Reporting 
Beginning at enrollment and proceeding throughout the duration of the follow-up period, 
the PI will closely monitor each subject for the development of adverse events. 
An AE is any new untoward medical occurrence (sign, symptom, or laboratory finding) 
in a clinical investigation subject, who was administered an Investigational Product that 
does not necessarily have a causal relationship with the Investigational Product. 
The severity of all adverse events will be graded on a scale of one through five according 
to the most recent version of the Common Terminology Criteria for Adverse Events 

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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 
The PI will categorize the relationship of the event to the Investigational Product as 
follows: 
 Unrelated: This category applies to those adverse events which, after careful 
consideration, are clearly and incontrovertibly due to extraneous causes 
(disease, environment, etc.) 
 Possible: This category applies to those adverse events 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 adverse events which, after careful 
medical consideration at the time they are evaluated, are felt with a high 
degree of certainty to be related to the Investigational Product. 
 Definite: This category applies to those adverse events which, after careful 
consideration, are clearly and incontrovertibly due to the Investigational 
Product. 
Any AE will be documented on the AE Report Form (Appendix F). 
7.2. 
Serious Adverse Event Reporting 
Beginning at enrollment and proceeding throughout the duration of the follow-up period, 
the PI will closely monitor each subject for the development of serious adverse events 
(SAEs). 
An SAE is defined as any adverse experience that results in any of the following 
outcomes: 
 Fatal 
 Life-threatening 
 Requires or prolongs inpatient hospitalization 

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 Results in persistent or significant disability or incapacity 
 A congenital anomaly or birth defect 
 An important medical event or requires medical intervention to prevent one of 
the above outcomes 
Any SAE occurrences (whether or not considered to be related to the Investigation 
Product) must be reported immediately, within 48 hours of awareness to Medline 
Industries, Inc. on the SAE Report Form (Appendix G) and be documented on the AE 
Report Form (Appendix F). 
7.3. 
Unanticipated Adverse Event Reporting 
An unanticipated AE is defined as any AE caused by, or associated with, an 
Investigational Product whose nature or severity is not consistent with the applicable 
product information. 
Reports which add significant information on specificity or severity of a known, already 
documented serious AE constitute unexpected events.  
All serious unanticipated AE that occur throughout the study duration are to be reported 
to Medline Industries, Inc., as well as to the respective IRB, as soon as possible and no 
later than 48 hours following acknowledgement. 
For questions regarding this process or the event, you may contact your Medline clinical 
designee or the Medline Clinical Associate Director: 
Name: Kara Cassady 
Office:  847-643-3809 
Fax:      866-758-4660 
E-mail:  KCassady@medline.com 
8. 
DATA MONITORING AND STATISTICS 
All information and data concerning subjects or their participation in this study will be 
considered confidential. Only authorized personnel will have access to these confidential 
files. All data used in the analysis and reporting of this evaluation will be without 
identifiable reference to the subject. No personal subject identification information 
should be included in any data submitted for the study. 
8.1. 
DATA COLLECTION 
All required data for this study will be collected on standardized CRFs (Appendix D). 
Qualified site personnel will perform primary data collection, drawn from the initial, 
interim, and final visits. Study monitors and/or designees will perform ongoing 
verification of source documentation via periodic on-site visits and remote monitoring. 
During this time, information will be reviewed for completeness and accuracy. Queries 

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may be generated for the site to resolve any issues identified. Data from the CRFs will be 
transferred to a secure electronic database maintained by Medline Industries, Inc. and 
stored on a secure server.  
8.2. 
SAMPLE SIZE JUSTIFICATION 
This is an observational study without a comparison group; therefore a formal power 
analysis is not feasible. Rather, the study will aim to collect data from 20 patients with 
evaluable data. The key analysis for the study is providing a quantitative estimate of 
debridement of necrotic tissue. To this end, a 95% confidence interval centered on the 
sample mean for necrotic tissue reduction will be created using the critical t value for 
this analysis; this will provide the best point estimate for debridement, as well as a 
measure of uncertainty, which will takes the sample size into account.  
8.3. 
ANALYSIS OF EFFICACY DATA 
8.3.1. Primary Endpoint 
Percent reduction in necrotic tissue will serve as the primary endpoint. The 
Investigator will analyze wound photographs and visually inspect the wound in 
order to calculate percent necrotic tissue and enter a value of 1-5, corresponding 
to: 
 1 = No necrotic tissue 
 2 = 0% - 25% 
 3 = 26% - 50% 
 4 = 51% - 75% 
 5 = 76% - 100% 
 
The 95% confidence interval for the mean reduction in necrotic tissue across the 
study period will be evaluated to determine if the lower bound is positive, which 
would be an indication of significant reduction in necrotic tissue.  
 
8.3.2. Secondary Endpoints 
 Percent patients with 100% wound closure in each group 
 Number of new infections in wound site  
 Change in wound volume over time, measured similarly to percent necrotic 
tissue; analyzed by providing the 95% confidence interval for the mean 
 Mean odor score between groups; analyzed by providing the 95% 
confidence interval for the mean 
 Mean pain score between groups; analyzed by providing the 95% confidence 
interval for the mean 
 Mean BWAT score between groups; analyzed by providing the 95% 
confidence interval for the mea 

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8.3.3. Evaluable Dataset 
 
An evaluable dataset will be used to conduct the efficacy assessments. This 
dataset will be defined as subjects who have at least a valid measurement for 
necrotic tissue from the Day 1 visit and their Final Visit, given that this will make 
up the measurement of the primary endpoint.  
 
8.4 ANALYSIS OF SAFETY DATA 
Subject withdrawal and the incidence and nature of AEs will be summarized in 
safety data assessments.  All treated subjects, defined as the safety population, 
will be the basis for all safety analyses. 
 
9. 
REFERENCES 
1. Schultz GS, Sibbald RG, Falanga V, et al.  Wound Bed Preparation: a systemic approach to 
wound management.  Wound Rep Regen 2003; 11 (Suppl 1): S1-28. 
2. Keast-Butler J. Honey for necrotic malignant breast ulcers. Lancet 1980; 2(8198): 809.  
3. Subrahmanyam M. Topical application of honey in treatment of burns. Br J Surg 1991; 
78(4): 497-8.  
4. Auerbach A, Katzper M. Assessment of visual analog versus categorical scale for the 
measurement of osteoarthritis pain.  J. Clin Pharmacol. April 2004; 44:368-372. 
5. Wound Zoom 
6.  Robson V, Dodd S, Thomas S. Standardized antibacterial honey (Medihoney TM) with 
standard therapy in wound care: randomized clinical trial. J Adv Nurs. 2009;65(3):565-575. 
7.  Jull A, Walker N, Parag V, Molan P, Rodgers A. Randomized clinical trial of honey-
impregnated dressings for venous leg ulcers. Br J Surg. 2008;95(2):175-182. 
 
 
 

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10. 
APPENDICES 
APPENDIX A: Therahoney® Foam Flex Product Information  
APPENDIX B: Subject Eligibility Questionnaire 
APPENDIX C: Bates-Jenson Wound Assessment Scale 
APPENDIX D: Case Report Form 
APPENDIX E: Subject-Specific Investigator Questionnaire 
APPENDIX F: Adverse Event (AE) Report Form  
APPENDIX G: Serious Adverse Event (SAE) Report Form 
 
 

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10.1 APPENDIX A: Therahoney® Product Labeling  
 

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10.2  APPENDIX B: Subject Eligibility Questionnaire 
Subject Eligibility Questionnaire 
Subject #: 16017- __ __ __ 
Age: _______ (yrs) 
Gender (please check on):                ☐  Male                 ☐ Female 
Yes           No  
Does the subject have a known sensitivity or allergy to honey based products, bee 
venom, or foam dressings? 
☐            ☐ 
Is the subject pregnant. breast feeding, or intending to become pregnant during the 
duration of the study? 
☐            ☐ 
Does the subject have any allergies? 
If so, what are they? __________________________________ 
☐            ☐ 
Preliminary Wound Analysis 
 
1. Is the chronic wound between 1 cm2 to 25 cm2 and been present for at least 4 
weeks?        
☐            ☐ 
2. Is the subject’s wound duration less than 52 weeks old? 
☐            ☐ 
3. Does the target wound meet the indication criteria listed in the product’s 
labeling?           
☐            ☐ 
4. Does the subject have adequate circulation as demonstrated by biphasic or 
triphasic Doppler waveform, measured within 3 months of study enrollment?  
Or, if monophasic on exam, does subject have an Ankle-Brachial Index greater 
than 0.8 and no worse than mild disease on segmental pressures, measured 
within 3 months of study enrollment? 
☐            ☐ 
5. Does the subject have either type I/II diabetes? 
If so, has the subject’s random blood glucose been less than 450 mg/dL within 30 
days of the screening visit? 
☐            ☐ 
☐            ☐ 
6. Does the target wound have at least 20% necrotic tissue 
☐            ☐ 
7. Is the subject currently receiving dialysis? 
☐            ☐ 
8. Does the subject’s prognosis indicate an unlikely survival past the study 
period? 
☐            ☐ 
9. Does the subject have third degree burns? 
☐            ☐ 
10.  Does the subject’s target wound present with gangrene or signs of infection? 
☐            ☐ 
11. Is the subject likely to be compliant with instructions for care and daily 
dressing changes? 
☐            ☐ 
12. Has the subject received any treatment prior to the study that may affect the 
outcome of the study? 
☐            ☐ 
This subject is: 
 
continuing in the study 
 
dismissed 

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If Subject is dismissed, please document reason. 
Subject did not meet qualification criteria: 
 explain: 
_______________________
______ 
Initials: ___________________         Date: _______________________ 
 
 
Approved by: _____________________________________ Date: ________________

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10.3  APPENDIX C: Bates-Jenson Wound Assessment Scale 
 
BATES-JENSEN WOUND ASSESSMENT TOOL 
     Instructions for use 
General Guidelines: 
 
Fill out the attached rating sheet to assess a wound’s status after reading the definitions and methods of assessment described below. 
Evaluate once a week and whenever a change occurs in the wound. Rate according to each item by picking the response that best 
describes the wound and entering that score in the item score column for the appropriate date. When you have rated the wound on all 
items, determine the total score by adding together the 13-item scores. The HIGHER the total score, the more severe the wound status is. 
Plot total score on the Wound Status Continuum to determine progress. If the wound has healed/resolved, score items 1, 2, 3 and 4 as =0. 
 
Specific Instructions: 
1. 
Size: Use ruler to measure the longest and widest aspect of the wound surface in centimeters; multiply length x width. Score 
as = 0 if wound healed/resolved. 
 
2. 
Depth: Pick the depth, thickness, most appropriate to the wound using these additional descriptions, score as 
0 = 
   if wound healed/resolved: 
1 =        tissues damaged but no break in skin surface. 
2 =        superficial, abrasion, blister or shallow crater. Even with, &/or elevated above skin surface (e.g., hyperplasia). 
3 =        deep crater with or without undermining of adjacent tissue. 4 =        
visualization of tissue layers not possible due to necrosis.   5 =        supporting 
structures include tendon, joint capsule. 
 
3. 
Edges: Score as = 0 if wound healed/resolved. Use this guide: 
 
Indistinct, diffuse 
= 
unable to clearly distinguish wound outline. 
Attached 
= 
even or flush with wound base, no sides or walls present; flat. 
Not attached 
= 
sides or walls are present; floor or base of wound is deeper than edge. 
Rolled under, thickened 
= 
soft to firm and flexible to touch. 
Hyperkeratosis 
= 
callous-like tissue formation around wound & at edges. 
Fibrotic, scarred 
= 
hard, rigid to touch. 
 
4. 
Undermining: Score as = 0 if wound healed/resolved. Assess by inserting a cotton tipped applicator under the wound edge; 
advance it as far as it will go without using undue force; raise the tip of the applicator so it may be seen or felt on the surface of 
the skin; mark the surface with a pen; measure the distance from the mark on the skin to the edge of the wound. Continue 
process around the wound. Then use a transparent metric measuring guide with concentric circles divided into 4 (25%) pie-
shaped quadrants to help determine percent of wound involved. 
 
5. 
Necrotic Tissue Type: Pick the type of necrotic tissue that is predominant in the wound according to color, consistency and 
adherence using this guide: 
White/gray non-viable tissue 
= 
may appear prior to wound opening; skin surface is 
white or gray. 
Non-adherent, yellow slough 
= 
thin, mucinous substance; scattered throughout wound 
bed; easily separated from wound tissue. 
Loosely adherent, yellow slough 
= 
thick, stringy, clumps of debris; attached to wound 
tissue. 
Adherent, soft, black eschar 
= 
soggy tissue; strongly attached to tissue in center or 
base of wound. 
Firmly adherent, hard/black eschar 
= 
firm, crusty tissue; strongly attached to wound base and 
edges (like a hard scab). 
2001Barbara Bates-Jensen 

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6. 
Necrotic Tissue Amount: Use a transparent metric measuring guide with concentric circles divided into 4 (25%) pie-
shaped quadrants to help determine percent of wound involved. 
 
7. 
Exudate Type: Some dressings interact with wound drainage to produce a gel or trap liquid. Before assessing exudate type, 
gently cleanse wound with normal saline or water. Pick the exudate type that is predominant in the wound according to color 
and consistency, using this guide: 
 
Bloody 
= 
thin, bright red 
Serosanguineous 
= 
thin, watery pale red to pink 
Serous 
= 
thin, watery, clear 
Purulent 
= 
thin or thick, opaque tan to yellow or green may have offensive 
odor 
 
8. 
Exudate Amount: Use a transparent metric measuring guide with concentric circles divided into 4 (25%) pie- shaped 
quadrants to determine percent of dressing involved with exudate. Use this guide: 
 
None 
= 
wound tissues dry. 
Scant 
= 
wound tissues moist; no measurable exudate. 
Small 
= 
wound tissues wet; moisture evenly distributed in wound; drainage 
involves < 25% dressing. 
Moderate 
= 
wound tissues saturated; drainage may or may not be evenly distributed in 
wound; drainage involves > 25% to < 75% dressing. 
Large 
= 
wound tissues bathed in fluid; drainage freely expressed; may or may not 
be evenly distributed in wound; drainage involves > 75% of dressing. 
 
9. 
Skin Color Surrounding Wound: Assess tissues within 4cm of wound edge. Dark-skinned persons show the colors "bright 
red" and "dark red" as a deepening of normal ethnic skin color or a purple hue. As healing occurs in dark-skinned persons, the 
new skin is pink and may never darken. 
 
10. 
Peripheral Tissue Edema & Induration: Assess tissues within 4cm of wound edge. Non-pitting edema appears as skin 
that is shiny and taut. Identify pitting edema by firmly pressing a finger down into the tissues and waiting for 5 seconds, on 
release of pressure, tissues fail to resume previous position and an indentation appears. Induration is abnormal firmness of 
tissues with margins. Assess by gently pinching the tissues. Induration results in an inability to pinch the tissues. Use a 
transparent metric measuring guide to determine how far edema or induration extends beyond wound. 
 
11. 
Granulation Tissue: Granulation tissue is the growth of small blood vessels and connective tissue to fill in full thickness 
wounds. Tissue is healthy when bright, beefy red, shiny and granular with a velvety appearance. Poor vascular supply appears 
as pale pink or blanched to dull, dusky red color. 
 
12. 
Epithelialization: Epithelialization is the process of epidermal resurfacing and appears as pink or red skin. In partial thickness 
wounds it can occur throughout the wound bed as well as from the wound edges. In full thickness wounds it occurs from the 
edges only. Use a transparent metric measuring guide with concentric circles divided into 4 (25%) pie-shaped quadrants to 
help determine percent of wound involved and to measure the distance the epithelial tissue extends into the wound. 
 
2001 Barbara Bates-Jensen 
 
 
 
 
 
 
 
 

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BATES-JENSEN WOUND ASSESSMENT TOOL          Subject Number: 
 
Complete the rating sheet to assess wound status. Evaluate each item by picking the response that best describes the wound and 
entering the score in the item score column for the appropriate date. If the wound has healed/resolved, score items 1,2,3, & 4 as =0. 
Location: Anatomic site. Circle, identify right (R) or left (L) and use "X" to mark site on body diagrams: 
 
         
Sacrum & coccyx 
         
Lateral ankle 
         
Trochanter 
         
Medial ankle 
         
Ischial tuberosity 
         
Heel 
         
Buttock 
         
Other site:                                         . 
Shape: Overall wound pattern; assess by observing perimeter and depth.  
 
Circle and date appropriate description: 
         
Irregular 
         
Linear or elongated 
         
Round/oval 
         
Bowl/boat 
         
Square/rectangle          
Butterfly              Other Shape 
 
Item 
Asses
Date 
Score 
Date 
Score 
Date 
Score 
1. Size* 
*0 = Healed, resolved wound 
1 = Length x width <4 sq cm 
2 = Length x width 4--<16 sq cm 
3 = Length x width 16.1--<36 sq cm  
4 = Length x width 36.1--<80 sq cm  
5 = Length x width >80 sq cm 
2. Depth* 
*0 = Healed, resolved wound 
1 = Non-blanchable erythema on intact skin 
2 = Partial thickness skin loss involving epidermis &/or dermis 
3 = Full thickness skin loss involving damage or necrosis of 
subcutaneous tissue; may extend down to but not through 
underlying fascia; &/or mixed partial & full thickness &/or tissue 
layers obscured by granulation tissue   
4 = Obscured by necrosis 
5 = Full thickness skin loss with extensive destruction, tissue necrosis 
or damage to muscle, bone or supporting structures 
3. Edges* 
*0 = Healed, resolved wound 
1 = Indistinct, diffuse, none clearly visible 
2 = Distinct, outline clearly visible, attached, even with wound base 3 
= Well-defined, not attached to wound base 
4 = Well-defined, not attached to base, rolled under, thickened  
5 = Well-defined, fibrotic, scarred or hyperkeratotic 
4. Under- 
mining* 
*0 = Healed, resolved wound 
1 = None present 
2 =Undermining < 2 cm in any area 
3 = Undermining 2-4 cm involving < 50% wound margins  
4 = Undermining 2-4 cm involving > 50% wound margins  
5 = Undermining > 4 cm or Tunneling in any area 
5. Necrotic Tissue 
Type 
1 = None visible 
2 = White/grey non-viable tissue &/or non-adherent yellow slough 
3 = Loosely adherent yellow slough 
4 = Adherent, soft, black eschar 
5 = Firmly adherent, hard, black eschar 

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6. Necrotic Tissue 
Amount 
1 = None visible 
2 = < 25% of wound bed covered  
3 = 25% to 50% of wound covered 
4 = > 50% and < 75% of wound covered  
5 = 75% to 100% of wound covered 
7. Exudate Type  
1 = None 
2 = Bloody 
3 = Serosanguineous: thin, water, pale red/pink 
4 = Serous: think, watery, clear 
5 = Purulent: thin or thick, opaque, tan/yellow, with or without odor 
8. Exudate Amount 1 = None, dry wound 
2 = Scant, wound moist but no observable exudate 
3 = Small 
4 = Moderate 
5 = Large 
9. Skin Color 
Surrounding 
Wound 
1= Pink or normal for ethnic group 
2 = Bright red &/or blanches to touch 
3 = White or grey pallor or hypopigmented 
4 = Dark red or purple &/or non-blanchable 
5 = Black or hyperpigmented 
10. Peripheral 
Tissue Edema 
1 = No swelling or edema 
2 = Non-pitting edema extends < 4cm around wound 
3 = Non-pitting edema extends ≥ 4cm around wound 
4 = Pitting edema extends < 4cm around wound 
5 = Pitting edema extends ≥ 4cm around wound 
11. Peripheral 
Tissue Induration 
1 = None present 
2 = Induration < 2cm around wound 
3 = Induration 2-4cm extending <50% around wound 
4 = Induration 2-4cm extending ≥50% around wound 
5 = Induration > 4cm in any area around wound 
12. Granulation 
Tissue 
1 = Skin intact or partial thickness wound 
2 = Bright, beefy red; 75% to 100% of wound filled &/or tissue 
overgrowth 
3 = Bright, beefy red; <75% & >25% of wound filled 
4 = Pink, &/or dull, dusky red &/or fills ≤25% of wound 
5 = No granulation tissue present  
13. Epithelialization 1 = 100% wound covered, surface intact 
2 = 75% to < 100% wound covered &/or epithelial tissue extends > 
0.5cm into wound bed 
3= 50% to < 75% wound covered &/or epithelial tissue extends < 
0.5cm into wound bed 
4 = 25% to < 50% wound covered 
5 = < 25% wound covered 
Total Score 
Signature: ______________________________________  Date: ____________ 
 
Plot the total score on the Wound Status Continuum by putting an "X" on the line and the date beneath the line.  Plot multiple scores 
with their dates to see-at-a-glance regeneration or degeneration of the wound. 2001Barbara Bates-Jensen

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10.4 APPENDIX D: Case Report Form 
Case Report Form (R16-017) 
Subject Number: 
Visit Date:                     Visit Time:                    AM  PM      Visit Type and Number:  
 
Height (inches):                      Weight (lbs):                       A g e : 
Sex: 
☐ Male 
☐ Female 
Race:     ☐ White      
☐ Black                            ☐ Hispanic or Latino                  ☐ Asian           ☐ Other/Mixed Race        ☐ Native American                                  
Was mechanical debridement used?       ☐ Yes         ☐ No 
Was a secondary dressing used?      ☐ Yes         ☐ No                            If yes, what kind? _______________________________________ 
Wound Assessment 
Physical Examination and Wound Zoom Analysis 
Bates – Jensen Wound Assessment Tool (BWAT) 
Diagnosis: ___________________________________________ 
What is the percent of necrotic tissue? ______ % 
Wound size (cm): Width______ x Length _______ x Depth ________ 
 Evaluation of odor: _______ 
 
      1                2                 3                 4 
VAS Pain scale score within 10 minutes following dressing change:  ____ 
 
Site Infection:        Yes         No 
If yes, discontinue subject and note steps taken: 
____________________________________________________________ 
 
1. Skin:  ____ 
2. Depth: ____ 
3. Edges: ____ 
4. Undermining:  ____ 
5. Necrotic Tissue Type:  ____ 
6. Necrotic Tissue Amount: ____ 
7. Exudate Type: _____ 
 
8. Exudate Amount: ____ 
9. Skin Color Surrounding Wound: ____ 
10. Peripheral Tissue Edema: _____ 
11. Peripheral Tissue Induration: ____ 
12. Granulation Tissue: ____ 
13. Epithelialization: _____ 
TOTAL BWAT SCORE: _________ 
1
2
3 
4 
5 
6 
7
8 
9 
10 
0
 
 

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Place photograph of the wound from the Wound Zoom camera below: 
Subject #: _________                  Date: ___________ 
*Please note that the information in the picture should match the above information. 
Signature ___________________________________     Date ______________ 

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 10.5 APPENDIX E: Subject-Specific Investigator Questionnaire 
Subject-Specific Investigator Questionnaire 
Subject #: 16017- __ __ __ 
 
1. In your opinion, was the product effective in healing the wound? 
 Yes* 
 No* 
*Comment: 
____________________________________________________________________________________________
____________________________________________________________________________________________ 
2. In your opinion, was the product effective in decreasing the subject’s exudate? 
 Yes* 
 No* 
*Comment: 
____________________________________________________________________________________________
____________________________________________________________________________________________ 
3. In your opinion, did the product help promote autolytic debridement? 
 Yes* 
 No* 
*Comment: 
____________________________________________________________________________________________
____________________________________________________________________________________________ 
4. How would you rate ease of 
use for the product on the 
wound? 
 0 
 1 
 2 
 3 
 4 
 5 
 6 
 7 
 8 
 9 
 10 
Very bad  - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - Very Good 
*Comment: 
____________________________________________________________________________________________
____________________________________________________________________________________________ 
5. How would you rate the 
performance of the product on 
the wound? 
 0 
 1 
 2 
 3 
 4 
 5 
 6 
 7 
 8 
 9 
 10 
Very bad  - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - Very Good 
*Comment: 
____________________________________________________________________________________________
____________________________________________________________________________________________ 
6. When selecting wound care 
products to treat a similar 
wounds in the future, how likely 
are you to choose the product? 
 0 
 1 
 2 
 3 
 4 
 5 
 6 
 7 
 8 
 9 
 10 
Very Unlikely  - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - Very Likely 
*Comment: 
____________________________________________________________________________________________
____________________________________________________________________________________________ 
Signature ______________________________   Date ___________________ 

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10.6 APPENDIX F: Adverse Event (AE) Report Form 
Site/Subject Information 
Study Sponsor: Medline Industries, Inc. 
Protocol Number: R16-017 
Site Number: 
Principal Investigator: 
Subject Number: 
Subject Initials: 
 
Adverse Event Information 
# 
Adverse Event: 
Start 
Date: 
DD-
MMM-
YYYY 
Stop 
Date: 
DD-
MMM-
YYYY 
Ongoing: 
Frequency: 
Severity: 
Outcome: 
IP Lot #: 
Relation-ship 
to IP: 
Action 
Taken  
with IP: 
SAE 
Status: 
Comment: 
 
 Expected 
 
 
 Yes 
 
 
 
 
 
 
 Yes* 
 
 Unexpected 
 No 
 No 
 
 
 Expected 
 
 
 Yes 
 
 
 
 
 
 
 Yes* 
 
 Unexpected 
 No 
 No 
 
 
 Expected 
 
 
 Yes 
 
 
 
 
 
 
 Yes* 
 
 Unexpected 
 No 
 No 
 
 
 Expected 
 
 
 Yes 
 
 
 
 
 
 
 Yes* 
 
 Unexpected 
 No 
 No 
 
 
 Expected 
 
 
 Yes 
 
 
 
 
 
 
 Yes* 
 
 Unexpected 
 No 
 No 
Frequency: 
Severity: 
Outcome: 
Relationship to IP: 
Action Taken with IP: 
SAE Status 
1 = Isolated 
2 = Intermittent 
3 = Continuous 
1 = Grade 1; mild 
2 = Grade 2; moderate 
3 = Grade 3; severe 
4 = Grade 4; life-threatening 
5 = Grade 5; death 
1 = Resolved, with no sequelae 
2 = Resolved, with sequelae 
3 = Unresolved 
4 = Death 
5 = Unknown 
1 = Not Related 
2 = Possible 
3 = Probable 
4 = Definite 
1 = None 
2 = Modified 
3 = Interrupted 
4 = Discontinued 
Death, life-threatening, prolonged 
hospitalization, significant 
disability/anomaly, medical 
intervention to prevent a serious 
outcome 
*In the event of a Serious Adverse Event, please complete the Serious Adverse Event Report form and send to Medline Industries, Inc. within 48 hours of awareness 
Initials: ___________________         Date: _______________________ 
 
 
Approval: ___________________         Date: _______________________ 

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10.7 APPENDIX G: Serious Adverse Event (SAE) Report Form 
Site Information 
Study Sponsor: Medline Industries Inc. 
Protocol Number: R16-017 
Site Number: 
Principal Investigator: 
Site Address: 
Report Type: 
 Initial 
 Follow-up 
 Final 
Form Completed By: 
Title: 
Telephone: 
E-mail: 
 
Serious Adverse Event Information 
Subject Number: 
 
Age: 
Gender: 
 Male 
 Female 
Investigational Product: 
Event Description: (Please include a detailed description of the event in question, including the results of any 
laboratory/diagnostic imagery testing) 
Site Notification  
of the Event: 
Date Notified: 
Time Notified: 
Method of Notification: 
Event Start/Stop: 
Start Date: 
Stop Date: 
 Ongoing 
Event Qualifiers: 
(Check all that apply) 
 Death 
 Intervention to Prevent Impairment 
 Life-Threatening 
 Disability/Permanent Damage 
 Initial or Prolonged Hospitalization 
 Congenital Anomaly 
 Other: 

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Relevant Medical History: 
Concomitant Medication/Device History: (Please include historical information such as medication/device name, dosage, 
frequency, route, start date, etc.) 
Relationship to 
Investigational Product 
(IP): 
 Not Related (event definitely not related to IP, as judged by the Principal Investigator) 
 Possibly Related (event maybe related to IP, as judged by the Principal Investigator) 
 Related (event definitely related to IP, as judged by the Principal Investigator) 
Action Taken with 
Investigational Product: 
 Discontinued- Please Provide Date: 
 Interrupted- Please Provide Date: 
 None 
Comments: 
Initials: ___________________         Date: _______________________ 
 
 
Approval: ___________________         Date: _______________________ 
 
Confirmation of Receipt:  
SECTION TO BE COMPLETED BY MEDLINE INDUSTRIES INC. 
Date Received: 
Time Received: 
Received By: 
Title: