Single-Stage Integra Reconstruction in Burns
Phase: NA
Conditions: Thermal Burn
Sponsor: HealthPartners Institute

Official title: Single-Stage Integra Reconstruction in Burns
NCT #: NCT03077087
Document date:  02/01/2015

Science and Merit – 2/2015 
Staff Only 
Project # 
PI:   
Submission Date(s): 
If you need help with this document, contact the Research Review office at 651-254-3391.  Please save a copy of this 
document to your desktop AND upload it using the icon next to the Science and Merit Narrative on the dashboard. 
The following 9 headings/sections highlighted in blue correspond with the criteria used to evaluate your proposal. All 
the questions/requests are highlighted in yellow; they all must be answered providing sufficient detail for a reviewer to 
determine whether the review criteria have been met. 
****MAIN RESEARCH QUESTIONS, STUDY AIMS, SPECIFIC HYPOTHESES**** 
1.1 
Please clearly state your overall research questions and/or study aims. 
Primary Research Question: 
Does combining the use of Integra®, a synthetic dermal substitute, with the application of a skin graft, known as 
autografting, into a one-stage procedure result in comparable outcomes to the standard two-stage procedure, so as to be 
a feasible, safe alternative to the standard two-stage approach? 
Primary Hypothesis: 
Single-stage Integra reconstruction is safe, i.e. does not result in increased infections, and effective, i.e. does not result in 
increased graft loss, justifying further study in small to intermediate-sized burns that could result in significantly reduced 
hospital stays in a specific burn population. 
****1.  BACKGROUND & SIGNIFICANCE**** 
1.2 
What is the specific knowledge gap that the project intends to fill?  Include a brief review of past research 
in this area, numbering your citations to relevant literature as well as including them in the reference 
section #9.1. 
Integra®, a synthetic dermal substitute, has been utilized in burn care for decades.1  Composed of a porous collagen-
chondroitin 6-sulfate fibrillary mat covered with a thin sheet of silastic, it serves to cover wound beds of freshly excised 
burns and allow for the infiltration of fibroblasts, capillaries, and macrophages, essentially creating a “neodermis” while 
also acting as a barrier against infection and a blockade against heat and moisture loss.1  Typically, 10-14 days after
Integra® placement, a patient returns to the operating room, the top silastic layer of the Integra® is removed, and an 
autograft – a split-thickness skin graft harvested from the patient – is applied directly on top of the incorporated Integra®.  
The result is regarded to be a cosmetically and functionally superior result to that which would have been obtained had 
the wound bed itself been autografted at the time of excision, as opposed to being covered by Integra® and autografted 
during a second operation.   
Advantages of Integra® use are several.  

There are cosmetic advantages and functional advantages to the end result when compared with grafting alone.2,3

Integra® provides a temporary infection and moisture loss barrier until the definitive coverage with the split-
thickness skin graft.  This divides the overall reconstruction, and, therefore, the associated physiologic insult into
two stages. It should be noted that this advantage did not start with the invention of Integra® – homograft and
allograft (cadaver) coverage provided temporary coverage prior to the advent of Integra®.

The neodermis allows for definitive coverage to be done with a thinner split-thickness skin graft than would
otherwise be utilized to cover an Integra®-free wound bed.  This allows for faster donor site healing with
decreased scarring and pain.  Additionally, in the setting of larger burns, the faster donor site healing means a
shorter time until these donor sites can be re-harvested to cover additional burned sites.
Disadvantages of Integra® include infection risk, the need for an additional surgery, the cost of Integra® itself, and the 
increased hospital length of stay necessitated by waiting for the additional surgery, although this latter point has been 
brought into question in severely burned patients.4

Integra® use in single-stage procedures to cover defects without grafting has shown benefit when defects are fairly small, 
e.g. fingertip injurires5, and small head and neck skin cancer resections.6,7  Single-stage resection, Integra® placement
and autografting has been successfully utilized in the setting of upper extremity avulsion injuries8 and was utilized in the
burn setting as mentioned in a 2012 letter to the editor published in Burns.9  This aforementioned letter to the editor
mentions a single-case.  To our knowledge no trial has been performed to evaluate the potential for a single-stage
Integra® reconstruction procedure in the burn population.
Furthermore, these studies, while encouraging, were performed with standard Integra®.  A thinner version of Integra®, 
which is half of the thickness of standard Integra®, has been developed for ease of use in trickier anatomic areas, such as 
the axilla, where increased flexibility would be useful.  We believe this decreased thickness would be useful in a single-
stage reconstruction, as skin grafts initially receive nutrients prior to incorporation and new blood vessel growth via 
imbibition.  While single-stage reconstruction with Integra® has been demonstrated with standard thickness Integra®, we 
believe this decreased thickness would increase the likelihood of graft survival due to the decreased distance of nutrient 
diffusion. 
1.3 
What preliminary results do you have that support your proposal? 
Our burn center has examined the use of Integra® with autografting in a single-stage procedure in the setting of chronic 
wounds.  In 2009, patients with chronic wounds refractory to treatment for more than 3 months in our wound clinic were 
considered for treated with Integra®. Six patients underwent a single-staged composite graft (Integra® + autograft). Of 
these six patients, all six had graft “take” classified as “good” at one week.  Five of the six had graft take classified as 
“good” at one month, with the remaining patient’s graft take classified as “fair”.  This was in the setting of chronic wounds, 
which are notoriously difficult to heal, typically due to patient comorbidities which impair vascularity of the wound beds.  
1.4 
What is the importance of the research to the scientific community? 
Demonstrating the safety and feasibility of single-stage Integra® reconstruction could lead the way towards changing the 
standard of care for a significant population of burn patients, potentially reducing the hospital stays of thousands of 
patients each year. 
****2.  APPROACH**** 
Some questions in this section do not apply to all study designs; please mark Not Applicable as appropriate 
2.1 
Describe the study design (e.g., “This is a randomized controlled trial to test the effect of a guided 
imagery intervention on sleep quality”). Please see this List of Study Designs. 
This is a prospective, descriptive, pilot case series involving patients with significant burns who are candidates for 
reconstruction with Integra®.  Should they choose to participate in the trial, the majority of a patient’s wounds would be 
treated in accordance with standard cares of the Regions Hospital Burn Center.  However, a small area of the wound 
would, at the time of excision, have the smallest sheet of thin Integra® (125 cm2) placed and be immediately autografted
with a 3:1 meshed split-thickness skin graft.  Of note, 125 cm2 represents approximately 0.7% of an average sized
patient’s total body surface area, so for even the smallest burns in our proposed trial, this area would represent a small 
portion of the patient’s area of injury.  The remaining injury areas would be covered with standard-thickness Integra® only.  
The donor graft, a 4 cm x 10 cm sheet of skin, would be meshed in a 3:1 ratio to be expanded to cover the 125 cm2 sheet
of thin Integra®. The patient’s post-operative care would be largely unchanged, although the patient would have a donor 
site of 40 cm2 that would be dressed and managed in the usual fashion.
Post-operatively, the patient’s care would be largely unchanged.  Progress of graft “take” at the single-stage 125cm2 site
would be monitored regularly.  Eventually, 10-14 days later, the patient would return to the operating room for eventual 
auto-grafting over their standard Integra®.  If autograft “take” at the single-stage site was poor, the area would be re-
grafted.  If graft “take” at the single-stage site was adequate, the area would not require additional surgery. Thus, the total 
number of surgeries would not be expected to change, as the patient will require two trips to the operating room 
regardless of trial enrollment.  The 125 cm2 site would be monitored daily after dressing “take-down” (typically post-
operative day 5) while hospitalized and then on a standard post-operative schedule for sloughing or graft loss, infection, 
hematoma or underlying blood collection, seroma or underlying fluid collection, and time to 95% healed. This last variable 
is measured by determining the post-operative day at which 95% of the surface area of the graft is covered with 
epidermis.  Because we are meshing the 40 cm2 sheet of skin in a 3:1 fashion, the resultant graft will look like a thin fence
of skin with open diamond-shaped interstices that will slowly each fill in from the peripheral surrounding skin as the graft 
heals.  It is these interstices that give the typical meshed appearance of healed skin grafts. When 95% of the open areas 
have filled in, that day is determined to be the time to 95% healing. Similarly, an adjacent area of identical size, which will 
be treated in the standard fashion, will be monitored serially and will serve as a control. Since patients will serve as their 
own controls, a direct comparison between reconstruction strategies will be enabled. 
2.2 
How are you identifying eligible subjects or records? (e.g., clinic visit, search of Epic, registry, etc.) 

Not Applicable 
Eligible patients will be adults (Age 18 or older) admitted to the Regions Hospital Burn Center with thermal burns that will 
be reconstructed with Integra®.  There is not a firm protocol in place for Integra® use – this is decided at the level of the 
burn attending physician on a case-by-case basis. 
2.3 
What is the study population of interest and what are the study inclusion/exclusion criteria? 
Inclusion criteria – English-speaking adult burn patients greater than 18 years old, admitted with burn injuries eligible for 
Integra® reconstruction at the discretion of the burn attending physicians. 
Exclusion criteria – patients with isolated hand or face burns – these burns are treated with sheet grafts (unmeshed); the 
3:1 mesh grafts would not be used on these cosmetically sensitive areas.  If they have hand and/or face burns in addition 
to other areas, they will not be excluded.  However, the study itself will not be performed on the hands or face.  
Additionally, patients unable to present to our clinic for routine follow-up due to geographic limitations or otherwise will be 
ineligible. 
2.4 
If you are not using the entire population of interest, what is the method for obtaining a subset or sample 
of this population? 
X 
Not Applicable 
2.5 
Will you need to perform “preparation for research” activities prior to consenting subjects for research? 
X 
No 
Yes 
Not 
Applicable 
If you answered yes above, appropriate preparation for research activities prior to consenting subjects must 
include the following process to determine inclusion/exclusion criteria:  
1)
Study staff will work with the PI to determine the methods used in identifying potential subjects for the
research.  For example, this may include creating an Epic Workbench report of patients who are in the hospital
and meet minimum criteria for the research.
2)
Study staff may access medical records of all potential subjects’ identified (i.e., Workbench) to determine
eligibility criteria using information that already exists in the medical record.  During this process, no identifiable
information may be recorded and any documentation made of a potential subject’s information that would
disqualify them will be destroyed.
If an eligible patient is not being cared for by the PI, study staff must approach the patient’s provider to
determine if it is appropriate to proceed with the consent process.
3)
If additional testing needs to be done to see whether a patient meets criteria for entry into the study, the PI or
staff will need to consent the patient first.
4)
If the preparation activity confirms a patient is a possible subject, PI/staff approaches the patient to begin the
consent process.
2.6 
Describe the steps in your recruitment process. 
Not Applicable 
Patients meeting inclusion criteria will be approached prior to their excision and Integra® placement procedure.  The risks 
and benefits of the study will be discussed so that informed consent could be obtained. 
2.7 
Describe any interventions that are used in this study. 
Not Applicable 
Enrolled patients will undergo a single-stage reconstruction of 125 cm2 of their burn – thin Integra® will be placed with an
immediate split-thickness skin graft placed at the time of the first surgery.  The remainder of their injury will be treated 

according to the routine standard of care – first-stage excision and Integra® placement with second-stage autografting 10-
14 days later. 
 
2.8 
Provide a brief, sequential, bullet-point description of the all the data collection activities you will conduct 
from start to finish (e.g., chart review, patient survey, follow-up visits, data pull from the electronic 
medical record, etc.) and who will conduct each.   Please see our Example of Data Collection Steps. 
 
After enrollment, we will collect  
 
-Age, gender, %BSAB, mechanism of injury, location of burns 
-presence of burn cellulitis 
 
-Post-burn day of Stage 1 of reconstruction (excision, Integra® placement, and 125 cm2 auto-graft) 
 
-location of 125cm2 single-stage reconstruction site 
 
-percentage of graft coverage at first dressing takedown, typically post-operative day 5 and then daily 
 
-post-burn day of Stage 2 of reconstruction (auto-grafting over remaining Integra®, re-grafting of initial 125 cm2 
study area if necessary. 
 
-time to 95% healing of single-stage grafted area and time to 95% healing of control 125 cm2 wound auto-grafted 
during second reconstruction procedure adjacent to the single-stage graft. 
 
-single-stage graft site complications (infection, hematoma, seroma, sloughing of graft) 
 
-adjacent (control) wound complications (infection, hematoma, seroma, sloughing of graft) 
 
2.9 
Provide a timeline for the main study activities.  Please see our Example Timeline 
October, 2016 – IRB submission 
December, 2016 – February, 2016 – patient enrollment 
March, 2016 – April, 2016 – Data Collection/Analysis 
May, 2016 – June, 2016 – Abstract/Manuscript preparation 
 
2.10 
Describe your plans for ensuring data security 
Once a patient is enrolled they are assigned a unique identification number that is assigned to that patient for the duration 
of the study.  The master database linking the patient name with the unique identification number is stored on one 
password-protected, secure computer in the Critical Care Research Center.  The center is a a locked office with limited 
accessibility.  All paper files are stored in locked cabinets at all times.  Research staff are fully trained in the elements of 
patient privacy and confidentiality. 
 
2.11. 
List the KEY variables that will be collected to support the study aims outlined in item 1.1.  KEY variables 
include those used for: 
1) achieving the study aims (outcomes, predictors, potential confounders),  
2) identifying the study population (for inclusion/exclusion criteria),  
3) describing the study population 
Please see an Example of a Completed Table and an Example Data Dictionary. 
Variable Name 
Data Source 
(patient survey, EMR, 
claims, registry) 
Purpose 
(sample identification,  
description, grouping 
variable, study endpoint, 
predictor, covariate) 
Measurement Scale 
(binary, continuous) 
Age 
EMR/Registry 
Description 
Continuous 
Gender 
EMR/Registry 
Description 
Binary 

Percentage of Body Area 
Burned (%BSAB) 
EMR/registry 
Description 
Continuous 
Burn Location(s) 
EMR 
Description 
Descriptive 
Presence of Burn Cellulitis 
EMR 
Confounder 
Binary 
Post-Burn Day of Stage 1 
(Tangential 
Excision/Integra® 
Placement with 125 cm2 of
auto-grafting) 
EMR 
Covariate 
Continuous 
Location auto-grafted 
EMR 
Description 
Descriptive 
Complications of Integra® 
EMR 
Covariate 
Descriptive 
Time to 95% healing of 
single-stage skin graft 
EMR 
Study Endpoint 
Continuous 
Complications of Stage 1 
Auto-graft (infection, 
hematoma, seroma, 
sloughing) 
EMR 
Study Endpoint 
Descriptive 
Post-Burn Day of Stage 2 
(auto-grafting remaining 
Integra areas) 
EMR 
Covariate 
Continuous 
Location of control auto-
graft 
EMR 
Description 
Descriptive 
Time to 95% healing of 
control skin graft 
EMR 
Study Endpoint 
Continuous 
Complications of control 
skin graft  (infection, 
hematoma, seroma, 
sloughing) 
EMR 
Study Endpoint 
Descriptive 
2.12 
Provide operational definitions of any variables listed above that aren’t adequately described by the 
variable name above, and provide a brief background of any validated measurement scales listed above. 
n/a 
2.13 
If you are collecting data elements besides those listed in Table 2.10 above, provide a justification for 
gathering the additional data. 
Reminder:  For chart review studies, a data collection form must be uploaded with your application listing variables 
collected and how they are recorded (chart review studies).  Provided are links to two example chart review tools: Word 
Chart Review Example and Excel Chart Review Example 
****3.  ANALYSIS**** 
3.1 
Describe the statistical methods that will be used to address the study aims.  For each aim, this will 
    usually include: 

 
Description of the sample used for the particular analysis 
 
The variables included in the specific analysis and their role in the analysis 
 
Numeric summaries computed (e.g., mean, standard deviation, proportion, correlation)  
 
A summary of data exploration and presentation activities (e.g., generating scatter plots, summary tables)  
 
Description of statistical tests (e.g., independent samples t-test, Mann-Whitney test), and models constructed (e.g., 
logistic regression) 
Please see our Examples of Statistical Methods. 
Describe here: 
Note:  Please reference the area/pages of an established protocol if you are not writing your own analysis plan.   
This is a descriptive pilot study.  Means and standard deviations will be computed to describe continuous variables and 
percents for binary or categorical variables.  Patient demographics (age, sex) will be tabulated to characterize the 
population. 
Aim 1 will be to describe the time to 95% healing of the single-stage reconstructed skin graft as well as to determine the 
frequency of complications of infection, seroma, hematoma, sloughing, and graft loss.  Aim 2 will be to compare that to the 
same characteristics of the adjacent (control) 125 cm2 skin graft. 
Frequency charts for incidences of complications between the single-stage and control skin grafts will be compared with 
chi-square tests.  Times to 95% healing will be compared with t-tests. 
 
Sample size: 
3.2 
What is the estimated sample size(s) for the primary study analyses (per group for studies with different 
arms or comparison groups)? 
We plan to evaluate this procedure in 10 patients. 
 
3.3 
The sample size selected was (check all that apply): 
 
Based on data likely to be available during a specific time period (often based on data available in past periods) 
 
To conduct one or more specific analyses with adequate statistical power  
 
To achieve a specified level of precision in one or more key estimates 
x 
Other (explain): This is a descriptive study 
 
3.4 
Explain your choice of the sample size selection you listed above: 
This is a pilot study – we believe we can enroll 10 patients in a 6 month timeframe and present our results at a regional 
and/or national conference to proceed with a multi-institutional study. 
3.5 Describe your assumptions concerning data available for analysis (e.g. How many subjects will be 
randomized, possibly lost to follow-up or a procedure?  What do you expect for survey response rates, and 
how much missing data do you expect?).  Include information as it pertains to your study (human or animal). 
We don’t believe any patients will be lost to follow-up, as we will be excluding patients based on this limitation.  We expect 
to have sufficient follow-up data on at least 90% of patients as our post-surgical clinic follow-up rates are above 90%. 
 
Power analysis 
NOTE: If you are doing a descriptive study (i.e., aside from computing confidence intervals you are not using statistical 
tests, inferential statistical testing for group comparisons, or statistical models), please complete 3.6 and skip 3.7-3.8.   
If you are conducting statistical tests, using statistical inference to compare groups, or are building statistical models, 
please skip 3.6 and complete 3.7-3.8.  Please see our Example Power Analysis. 
 

3.6 
Provide a measure of the precision of your estimates for key study endpoints, (e.g., 95% confidence 
intervals on proportions or means), using actual expected estimates.   
This study will be descriptive. 
We believe that there will be no increase in graft loss or delayed time to healing, but do not have a precision measure of 
this information.  Our results will be precisely described our findings. 
3.7 
What level of differences observed in your primary endpoints would be considered clinically or practically 
significant? 
 
 
3.8 
What is the power for your primary analysis (and the set of assumptions underlying it: hypothesis 
addressed, expected pattern of effects with justification for these expectations, analysis used, variables 
in the analysis, effect sizes, sample sizes, alpha level, one or two-sided test)? 
 
 
3.9 
What are the limitations of the proposed approach and analysis? 
The limitations are precisely that this is a descriptive pilot study based on a total of 10 patients.  While we will characterize 
our data accurately, this will not be a large enough study, nor will we be auto-grafting a large enough area to extrapolate 
single-stage reconstruction of large burns.  However, should the procedure be deemed safe and effective, it would serve 
as a springboard to a multi-institutional study involving single-stage reconstruction of small burns, with the definition of 
“small” to be determined. 
 
3.10 
Please name the people who completed the analysis section of this application. 
Sam Miotke, MD 
 
3.11 
Please name the people who will summarize data and conduct statistical analysis. 
Sandi Wewerka, MPH 
****4.  RESEARCH TEAM**** 
List your study team 
and degrees. 
List what each person will do: 
Identify study subjects; Data 
entry; Chart abstraction; 
Statistical analysis; Study 
recruitment Interview patients; 
Draft and revise manuscripts  
List each person’s experience 
Explain each person’s previous 
research experience with the tasks 
assigned or what other 
background/experience relates to the 
task they are assigned. 
Time Estimate 
Please estimate the 
number of hours or 
% effort each 
person will spend 
on the study 
Sam Miotke, MD, MS 
Identify subjects, data entry, chart 
abstraction, statistical 
analysis, study recruitment, 
draft and revise manuscripts 
Burn Research Fellow; UMN Surgery 
Resident (PGY-5), currently in second 
year of research time. 
5% 
William Mohr, MD, 
FACS 
Identify subjects, draft and revise 
manuscripts 
Decades of experience in burn and 
trauma surgical research 
2% 
Nicole Kopari, MD 
Identify subjects, draft and revise 
manuscripts 
Years of experience in burn and 
trauma surgical research 
2% 
Sandi Wewerka, MPH 
Data analysis, draft and revise 
manuscripts 
Decades of research and study 
coordinator experience 
2% 
 
****5.  DISSEMINATION**** 
5.1 
What are your plans for publication, including target journals? 
Journal of Burn Care and Research 
Burns 
 

5.2 
What plans do you have to share results or translate results to care delivery at HP or for HP personnel? 
This is a pilot study.  The results will be discussed at a burn conference as well as, ideally, at the American Burn 
Association annual meeting as well as the Midwest Regional Burn meeting.   
****6.  ENVIRONMENT**** 
6.1 
Where will the study be conducted?  Why is the proposed location appropriate for study? 
The study will be conducted at the Regions Hospital Burn Center, where patients are treated.  
6.2 
How will the results of this study impact the health of HealthPartners members and the community?  Be 
specific as to whether and how you see any clinical application as a result of this study. 
This could lead to changes that eventually affect standard of care of a not insignificant portion of burn patients, decreasing 
costs and shortening hospital stays while maintaining safety and effective clinical outcomes. 
 
6.3 
Does the treatment strategy (drug or service) proposed in the study commit HP to covering or continuing 
to provide the treatment or program support after the study is completed? 
No 
 
 
****7.  OTHER REVIEW**** 
7.1  
Has this study been submitted for other review and/or received approval/rejection previously, including 
but not limited to: Federal, collaborative agency, previous HealthPartners (rejected), or other funding 
sources (e.g., nonprofit foundation review)? 
X 
No 
 
Yes (Provide dates of submission and status of review [approved, pending, or rejected]) 
 
 
 
 
7.2 Does this study require review by HealthPartners Radiation Safety Officer?  
X 
No 
 
Yes 
Please state that you have spoken to the Radiation Safety Office (651-254-3322) and have their 
support for this study.  
 
 
 
If a research protocol is to involve the use of ionizing or non-ionizing radiation, the principal investigator (PI) should 
contact the Institutional Radiation Safety Officer (RS0) for Regions Hospital and HealthPartners clinics. 
Regions Radiation Safety Office: 651-254-3322. 
Frank E. Zink, Ph.D.,  Radiation Safety Officer for X-Ray Use 
Yuanlin Peng, Ph.D.,  Radiation Safety Officer for Radioactive Materials 
 
****8.  DATA ACCESS REQUEST**** 
These questions must be completed if you are accessing HP/Regions data or if you study involves a 
HealthPartners Institute programmer.  You will need to work with an Institute programmer to complete this form.  
Please contact Ann Hanson (952-967-5263) or Teri Defor (952-967-7304) for assistance.   

If you are not proposing the access HP/Regions data (e.g. Animal Study), you may check “N/A” below. 
8.1 
What is the name of the programmer helped you complete this section? 
8.2 
Will you need to add a programmer to your study team? 
X 
No 
Yes 
8.3 
Considering your inclusion/exclusion criteria described in 2.3, what specific data will you need? 
8.4 
What years of data are needed? 
This is a prospective study 
8.5 
Will any of the study data be shared or transferred to others within HealthPartners? 
Yes, all members of the study team will have access to the data. 
8.6 
Will any study data be shared or transferred to others outside of HealthPartners? 
X 
No 
Yes - mark which method you will use to share study data: 
[   ] E-transfer 
[   ] Secure website/portal 
[   ] Other secure, encrypted method.  Describe below. 
8.7 
Data Sources (please mark all known data sources) 
Mark 
(X) 
Data Source 
Mark 
(X) 
Data Source 
EWIS – Claims Data 
Registries (chronic condition, disease) 
RDW (Research Data Mart) – historical medical, 
dental, state death data 
Inpatient Case Management data (i.e., Care 
Guide, Care Partner) 
Claims/Mumps/Cache 
Paper Medical Chart 
X 
EPIC (Electronic Medical Record) 
Provider’s own source (own patient’s chart, 
provider or department/hospital registry) 
EDR (Electronic Dental Record) 
Geriatric department data (i.e., transitional, 
long term care database) 
EDR Reporting 
Data directly from contracted clinics 
New Subject Survey 
VDW (Virtual Data Warehouse) 
MEDIPAC System (Regions Billing System) 
Consolidated Network Provider (CPN) 
Physician Services Department Data 
Health Behavior Group Data (e.g., 10,000 

steps, HRA) 
MN State Death Data 
MN State Birth Data 
Misys/Sunquest (Lab production system) 
Clarity (Epic Reporting Database) 
Other (Please describe): 
8.8 
Exclusion Lists: Institute programmers are required to review and apply the following privacy 
requirements to study patients and their wishes regarding access to medical record information. 
Mark X 
Exclusion List 
HealthPartners Institute Exclusion List which excludes persons from all medical research.  This 
should be used for all studies.  Applies to all data used internally and externally. 
Gramm-Leach-Biley Opt-Out List: (if known; sometimes this can be determined after a study starts).  
Applies to identifiable data being sent externally. 
Consent for Treatment-Payment-Operations (TPO) Opt-Out List:  (if known; sometimes this can be 
determined after a study starts).  Applies to identifiable data being sent externally. 
8.9 
Data Elements (Please mark all elements that will be used/ accessed during the study): 
Mark 
(X) 
Data Elements 
   X 
Name 
Address 
Telephone Number (any) 
Fax Number 
Certificate/license number (i.e., DEA number, professional license number) 
Email address 
Device identifier or serial number 
URL or IP address (web addresses) 
    X 
Full face photos, biometric identifiers, or other images 
Health Plan beneficiary number (or family contract number) 
Date of Birth 
Vehicle identification or serial number 
    X 
Medical Record number (or any personal record identifier) 
8.10 
Data Content (Please mark all content areas that apply to your study 
Mark 
(X) 
Data Content 
X 
Demographic: age and gender 
Health Plan enrollment information (i.e., dates, coverage) 
Diagnoses - Medical 
X 
Procedures - Medical 
Mortality Data 
Lab Results 
Prescriptions/ Medications 

Dates of Service (treatment) 
Facility or Provider Identifier / Characteristics (e.g., specialty, FTE, Clinic) 
Birth Certificate Data 
Pathology / Tissue Type 
Financial data 
X 
Provider notes 
Vitals – height, weight, BP, etc 
Social history – tobacco use, etc. 
Other Clinical data 
X 
Other: please describe:  Wound and graft photographs 
****9.  REFERENCES**** 
9.1 
Please list below or attach a list of numbered references to support your literature review in section 1 
above. 
1.
Heimbach D, Luterman A, Burke J, Cram A, Herndon D, Hunt J, Jordan M, McManus W, Solem L, Warden G,
Zawacki B. Artifical dermis for major burns: a multi-center randomized clinical trial. Ann Surg 1988;208(3):313-9.
2.
Nguyen DQA, Potokar TS, Price P. An objective long-term evaluation of Integra® (a dermal skin substitute) and
split thickness skin grafts, in acute burns and reconstructive surgery. Burns 2010: 36: 23-28.
3.
Branski LK, Herndon DH, Pereira C, Micak RP, Celis MM, Lee JO, Sanford AP, Norbury WB, Zhang X, Jeschke
MG. Longitudinal assessment of Integra® in primary burn management: a randomized pediatric clinical trial. Crit
Care Med 2007;35:2615-23.
4.
Ryan CM, Schoenfeld DA, Malloy M, Schulz III, JT, Sheridan RL, Tompkins RG. Use of Integra® artificial skin is
associated with decreased length of stay of severely injured adult burn survivors. J Burn Care Rehabil
2001;23:311-7.
5.
Jacoby SM, Bachoura A, Chen NC, Shin EK, Katolik LI. One-stage Integra® coverage for fingertip injuries. HAND
2013;8:291-5.
6.
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