Clinical trial NCT02527512
Conditions: Surgical Site Infection
Keywords: Scoliosis Spine fusion 0.35% povidone-iodine
Sponsor: Boston Children's Hospital
Start date: 2017-07-13; Completion date: 2019-07-12
Enrollment: 173 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the safety of povidone-iodine irrigation in pediatric spinal patients by collecting pre- and post-operative safety labwork. Furthermore, the efficacy of povidone-iodine and normal saline irrigation at reducing bacterial contamination of the surgical wound will be measured by collecting cultures before and after irrigation.

Detailed description:
Previous research has shown there is baseline bacterial contamination of surgical spinal wounds prior to closure. While this bacterial contamination may or may not lead to infection, recent adult studies demonstrated reduced infection rates by using povidone-iodine irrigation before closure. This study will determine the safety of using povidone-iodine irrigation in pediatric spinal patients and how effective it is at reducing bacterial contamination of the spinal surgical wound prior to closure, compared with normal saline. The investigators hypothesize povidone-iodine is both safe and effective. Understanding techniques that reduce the local bacterial load in the wound prior to closure after spinal fusion will give data to support measures that will ultimately reduce the rate of postoperative infections.

Arms: arm 1: 0.35% povidone-iodine ("Betadine") arm 2: Sterile sodium chloride (NaCl) solution
Interventions: intervention 1: Povidone-Iodine intervention 2: Normal Saline
Intervention descriptions: intervention 1: Chemical complex of polyvinylpyrrolidone (povidone, PVP) and elemental iodine intervention 2: Solution of 0.90% w/v of NaCl, 308 mOsm/L or 9.0 g per liter

Protocol documents:
Prot_SAP_002.pdf: 
 
 
 
 
 
 
Bacterial Wound Contamination Prior to Closure: Povidone-iodine 
versus Saline Irrigation in Pediatric Spine Fusion Surgery 
 
 
 
 
Version Date: October 16, 2017 
 
 
 
Principal Investigator:   
Michael P. Glotzbecker, MD  
Assistant Professor, Harvard Medical School  
Department of Orthopaedic Surgery 
Children's Hospital Boston 
300 Longwood Avenue  
Boston, MA 02115 
Michael.Glotzbecker@childrens.harvard.edu 
 
 
Co-Investigator:   
John M. (Jack) Flynn, MD 
Richard M. Armstrong Jr. Professor of Orthopaedic Surgery 
Perelman School of Medicine at the University of Pennsylvania  
Chief of Orthopaedic Surgery 
The Children's Hospital of Philadelphia 
3401 Civic Center Blvd 
Philadelphia, PA 19104 
FLYNNJ@email.chop.edu 
 
Co-Investigator:   
Richard M. Schwend, MD 
Director, Orthopaedic Research Program 
Chair, American Academy of Pediatrics, Section on Orthopaedics 
Professor Pediatric Orthopaedic Surgery, University of Missouri-
Kansas City School of Medicine and University of Kansas Medical 
Center 
Children's Mercy Hospital & Clinics 
2401 Gillham Road 
2nd floor Annex 
Kansas City, MO  64114 
rmschwend@cmh.edu 


PI: Michael Glotzbecker, MD 
Page 1 
A.  Scientific Aims 
    The overall goal is to evaluate the safety and efficacy of surgical site irrigation with povidone-iodine in children and young adults 
undergoing spinal deformity surgery.  More specifically, we will:  (1) Establish safety of use of dilute povidone-iodine irrigation, 
(2) Establish baseline tissue colonization prior to closure, (3) Establish bacteriology of tissue contamination prior to closure, (4) 
Establish population (ie idiopathic vs neuromuscular) specific differences in tissue colonization prior to closure, and (5) Establish 
estimates for the effect that povidone-iodine/saline have on reducing bacterial contamination.  
B.  Significance 
    Due to their profound financial, personal, and societal costs, interventions focusing on preventing post-operative spine infection 
are of considerable interest.[1-5] The proposed study will hopefully demonstrate that using povidone-iodine irrigation in pediatric 
spinal patients is safe and reduces bacterial contamination of the spinal surgical wound prior to closure.  Following this pilot and 
assuming there is a reduction in bacterial contamination, we would conduct a multicenter randomized controlled trial (RCT) to assess 
whether the reduction leads to a lower postoperative spinal infection rate. 
C.  Background  
    The rate of wound infection in pediatric and adolescent spine fusion populations has been reported at 0.5-4.3%[4, 6-9] and 8-
24% in populations with neuromuscular disease.[4, 10-21] A recent retrospective review of Boston Children’s Hospital demonstrated 
at 10% infection rate in neuromuscular scoliosis over a 3 year period (unpublished data) and a recent multicenter study (unpublished 
data) demonstrated a 9.2% rate in neuromuscular scoliosis across 3 centers.  Based on recent research, we know that there is bacterial 
contamination of the spinal surgical wound prior to closure. Dietz et al. obtained positive wound cultures in greater than half of 
patients undergoing clean, elective orthopaedic procedures with no antibiotic prophylaxis.[22]  Nandyala and Schwend reported a 
23% rate of positive tissue cultures from pediatric patients undergoing posterior spinal fusion, which included a rate of 37% in 
neuromuscular patients.[23] 
    Povidone-iodine has long been used topically as a solution to disinfect the skin, and has been used as an intra-operative irrigant 
for general, cardiothoracic and genitourinary procedures.[24] The standard protocol for irrigation prior to wound closure in spine 
surgery entails the use of sterile normal saline as an irrigant.  Based on its theoretical ability to disinfect the surgical wound prior to 
closure, two RCTs comparing povidone-iodine to normal saline irrigation prior to wound closure in an adult spine population have 
demonstrated benefit without complications related to treatment.[25, 26] A recent systematic review on the use of povidone-iodine 
as a surgical irrigant in adult and pediatric patients concluded that the published studies showed compelling evidence of decreased 
infection with the use of povidone-iodine, although the level of evidence of these studies was sub-optimal.[27] Based on a number 
of in vitro and clinical studies, the best available evidence suggests that a concentration of 0.35% is both safe and effective.[27-34] 
D.  Methods 
    This will be multi-center, single-blind pilot randomized clinical trial (RCT) comparing povidone-iodine irrigant to normal saline 
alone.   
D.1.  Recruitment, Screening and Eligibility 
Participating orthopaedic surgeons and the study coordinator will be responsible for case finding and subject recruitment.  Patients 
will be screened and those found eligible will be offered participation. Informed consent will be obtained from the patient or from a 
parent or legal guardian for patients less than 18 years of age.   
D.1.a.  Inclusion criteria:  Patients must meet all of the following criteria to be eligible: (1) Age 3 to 18 years on day of surgery, (2) 
diagnosis of spinal deformity, (3) undergoing elective posterior spine multi-level instrumentation surgery 
D.1.b.  Exclusion criteria:  Patients having any of these criteria will be ineligible: (1) Documented renal failure, (2)  documented 
allergy to iodine or shellfish, (3) previous spine fusion surgery, (4) undergoing elective posterior spine instrumentation surgery 
fusing fewer than six levels, (5) undergoing anterior or anterior-posterior spine multi-level instrumentation surgery; (6) current 
antibiotic use. 
D.2.  Randomization and Blinding 
    Patients will be randomized to saline or povidone-iodine & saline irrigation via an envelope system.  Patients will be blinded to 
the type of irrigant used.  Ideally, surgeons would also be blinded to treatment group; however, it is not possible because they will 
be irrigating the surgical wound in the operating room and the two solutions will be identifiable because they are a different color.   
D.3.  Description of Study Treatments 
D.3.a.  Standardization of Periprocedure interventions 
   All patients will receive cefazolin (25 to 50 mg/kg, dependent on standard of care) IV within one hour prior to skin incision. 
Patients will also receive IV gentamycin or tobramycin (2.5 mg/kg) every 8 hours if they have a neuromuscular diagnosis. 
Appropriate every 3 or 4 hour (according to standard of care) dosing will be continued intraoperatively and for 24 hours post-
operatively.  If a patient allergy to cefazolin exists, clindamycin dosed every 6 hours or vancomycin dosed every 12 hours may be 
substituted.  Skin will be prepped with chlorhexidine.[24] Surgical approaches, fusion levels, deformity correction techniques, and 
hardware selection will be at the discretion of the surgeon.   
D.3.b.  Standardization of Culture/Irrigation Procedure 
    Prior to closure, a swab or tissue of the surgical wound will be performed (aerobic cultures) to establish the baseline incidence of 
bacterial contamination. This will be performed by excising the tissue or swabbing the wound under the retractor at the inferior 
aspect of the wound, using the routine surgical pathology protocol of the institution.  Following, any nonviable tissues will be 
debrided and the irrigant solution (0.35% povidone-iodine or sterile saline) of sufficient volume to fill the wound will be in contact 
with all areas of the wound for three minutes.  A second sample (aerobic cultures) will be collected immediately after lavage with 
saline or povidone-iodine from the same location to determine reduction in the incidence of bacterial contamination achieved by 


PI: Michael Glotzbecker, MD 
Page 2 
each irrigant. This sample will be obtained prior to placement of bone graft/antibiotics to obtain samples as close to closure as 
possible without allowing the application of local antibiotics to influence the results. A further 2 liters of normal saline will then be 
used for the povidone-iodine treatment group to irrigate the wound further which will remove traces of the iodine irrigant from the 
surgical site. If deemed appropriate by surgeon, a patient in the saline treatment group will then be irrigated with povidone-iodine 
and saline as per standard of care. Use of pulse or low pressure lavage will be up to the discretion of the surgeon.  
D.4.  Definition of Endpoints 
    (1)Proportion of patients with an initial positive bacterial culture prior to irrigation (2) Bacteriology of tissue in cases of positive 
cultures, and (4) Proportion of patients with a positive bacterial culture after irrigation 
D.5.  Data Collection Methods, Assessments and Schedule 
    Data will be collected on standardized paper case report forms (CRF) by the study coordinator and entered into a study-specific 
REDCap database.  Study data will be collected at the pre-operative consultation, and during surgery (see Table 1.)  Wound cultures 
will be tested specifically for research to evaluate the efficacy, respectively, of povidone-iodine. 
 
Table 1. Schedule of Measurements 
Measurement 
Baseline  
(Pre-Operative) 
 
Surgery 
 
Demographics 
X 
 
Medications 
X 
 
Medical history 
X 
 
Laboratory results 
X 
X 
Surgical site cultures (2) 
 
X 
Surgery/OR data 
 
X 
    Demographics, medications, medical history, and laboratory results will be collected from medical records. Surgical data will be 
collected during the fusion operation and two standard cultures of the surgical site will be taken during the surgery using the routine 
surgical pathology protocol at each institution.  Results from the cultures taken at the fusion operation, in addition to any other 
associated post-operative cultures, will also be collected post-operatively from medical records. 
 
D.6.  Adverse Events and Reporting Procedures 
The only foreseeable, but highly unlikely adverse event associated with participation in this trial is an increased level of iodine 
in the blood as a result of washing the wound site with povidone-iodine.  Extra iodine in the body is excreted through urine. A 
healthy body without thyroid or renal abnormalities is able to excrete excess iodine without any problems.  
The monitoring of adverse events will be conducted on an ongoing basis for the duration of the study.  If an adverse event occurs, 
it will be reported immediately to the IRB and the investigators will re-assess the risk/benefit ratio of the study and submit any 
modifications deemed necessary to the IRB for approval. 
 
D.7.  Statistical Considerations 
    We project an accrual of 150 patients, resulting in 75 per treatment group.  Patients will be recruited from “low risk” and “high 
risk” patient populations in a 3:1 fashion, respectively. “Low risk” patients are defined as those with an idiopathic condition and 
the “high risk” group will encompass all others. Within each patient “risk” group, randomization will be split evenly between 
saline and betadine in a 1:1 fashion. Positive cultures before and after irrigation will be monitored to establish the efficacy of 
povidone-iodine irrigation. 150 patients will provide good statistical precision for estimating the probability of a positive pre-
irrigation culture, as shown in the following table.  The table shows exact 95% confidence intervals (CI) for the estimated 
percentage over a plausible range of observed outcomes. 
Observed percentage: 
30/150=20% 
37/150=24.7% 
45/150=30% 
                     95% CI: 
(14%, 27%) 
(18%, 32%) 
(23%, 38%) 
 
    It will be of interest to examine how the tissue colonization rate varies across subgroups such as neuromuscular and idiopathic 
patients, which we anticipate to accrue in approximately a 3:7 ratio.  Under this assumption, and assuming an overall pre-irrigation 
colonization rate of 25% and a two-sided α=.05 test there will be 69%, 90% and 98% power, respectively, to detect relative risks 
(RR) of 2.0, 2.5, and  3.0, respectively. 
    Finally, we expect that the probability of a positive post-irrigation culture in the control group with will be about .12, with a 
further reduction to perhaps .05 in the povidone-iodine group.  These results would correspond to a relative risk (RR) of .417.  
Because positive post-irrigation cultures are projected to be fairly rare events, the size of this pilot study will not provide high 
statistical power unless the true treatment effect is quite large.   However, the study should provide useful preliminary information 
about the size of the treatment effect.  For example, the following table shows the probability that the estimated positive culture 
rate in the povidone-iodine group that will be at least 4, 5.33, 6.67 or 8 percentage points lower than in the control group, assuming 
the true control rate is .12 and the true rate in the povidone-iodine group is .05, .04 or .03 (corresponding to RR’s of .417, .33 and 


PI: Michael Glotzbecker, MD 
Page 3 
.25, respectively.   Calculations are based on exact binomial probabilities.  Also shown is the power of the study under each set of 
assumptions, assuming a two-sided α=.05 chi-square test. 
 
Number of fewer  pos. 
cultures (of 75) in 
treatment group. 
Observed percentage 
point reduction 
True rates     RR 
.12 vs .05    .417 
True rates     RR 
.12 vs .04     .33 
True rates     RR 
.12 vs .03     .25 
≥3 
≥4% reduction 
79% 
86% 
91% 
≥4 
≥5.33% reduction 
70% 
78% 
85% 
≥5 
≥6.67% reduction 
58% 
67% 
76% 
≥6 
≥8% reduction 
47% 
54% 
65% 
 
Power: 
33% 
43% 
55% 
 
For example (see bolded entry), if the true rates of post-irrigation positive cultures are .12 and .05 in the control and povidone-
iodine groups, respectively, corresponding to RR=.417, there is a 79% chance that the observed rates will differ by 4 percentage 
points or more (i.e., 3 or fewer positive cultures out of 75 in the treatment group compared with the number of positive cultures out 
of 75 in the control group).  However, there is only a 33% chance of finding a statistically significant difference (power=33%). 
 
E. Data Management Methods 
Every center participating in the trial has a research coordinator on staff that will be responsible for screening and consenting 
patients, collecting and entering data, and sharing data with the data coordinating center (see paragraph below). Each institution 
will be given an identifying number, which will be the beginning of each patient’s study identification number. Therefore, the 
patient study identification numbers will be linked to the patients’ institution and MRN.  Only members of the study group at each 
institution will have access to the links, which will be destroyed once all of the data is collected.  
 
Access to the REDCap™ database will be set during the creation of the project assigning a password to only members specified in 
the IRB protocol.  As this is a multi-center study, sites will only have access to their own site level data.  Boston Children’s 
Hospital, as the coordinating center, will have access to all data.  As other investigators or centers join the study, access will be 
granted only with appropriate IRB approval and they will only have access to their own data. 
 
At the local level, all hard copies of forms that the surgeons or research staff fill out with identifying information on it will be stored 
in a locked research cabinet in the department and entered into databases only accessible by members of the research staff. A subject's 
identity on these records will be indicated by a study ID number (a unique identification number created using an algorithm  the 
study administrators will define) rather than by name, and the information linking these study ID numbers with the subjects identity 
will be separate from the research records and research databases.  Only the researchers listed in this protocol will have access to a 
subject's research records, with the exception of the informed consent form, a copy of which will be kept in the medical record of 
each subject as this study involves a treatment based protocol.  Any information about subjects from this research will be kept 
confidential as possible.   
 
F. Quality Control Method 
The principal investigator will conduct an evaluation of the progress of the research study on a quarterly basis including assessments 
of data quality and timeliness; participant recruitment, accrual, and retention; and a review of outcome and complication data to 
determine whether there is any change to the anticipated benefit-to-risk ratio of study participation and whether the study should 
continue as originally designed, should be changed, or should be terminated.  A summary of these reports will be submitted to sites 
IRBs and to BCH as part of the annual renewal. 
 
G. Data Safety Monitoring Plan 
To ensure safety, an independent safety monitor will be appointed to assist with interim data review.   The monitor and 
the study statistician will be completely unblinded to treatment-group-specific results. There will be one scheduled interim 
analysis, conducted when data from approximately 1/3 and 2/3 of the accrual goal become available.  Interim analysis will focus 
on the comparison of the treatment groups with respect to the primary endpoint, positive culture rate before and after irrigation, 
using two-sample t-tests.  A “stopping rule” using a truncated O’Brien-Fleming procedure will be used to guide the need for 
further discussion of the possibility of early stopping among a wider group, including the study investigators.  (This rule will not 
be interpreted strictly but rather will be used as a guideline to trigger the need for a wider discussion.)  Specifically, the rule is that 
the stopping boundary is met if the nominal p-value is p<.001 at the first look or p<.0141 at the 2nd look.  The actual O’Brien-
Fleming rule would use a nominal p-value boundary of p<.00052 at the first look but this is extremely conservative (i.e., it would 
take an extreme treatment effect to meet this criterion) so the boundary had been truncated to p<.001.  Along with a criterion of 
p<.0451 at the final analysis, this algorithm ensures an overall type I error of 𝛼=.05.  The stopping rule has a minimal effect on 
statistical power, less than one percentage point.  
 In addition to the scheduled interim analysis, the safety monitor will review cases of positive culture results and adverse 
events. The safety monitor will also review any cases where a patient may require additional testing to follow up on a thyroid or 


PI: Michael Glotzbecker, MD 
Page 4 
renal abnormality that develops and advise on whether a wider discussion of early stopping should take place.  Such cases will also 
be reported to the IRB.  
 
 
 
H. Project Timeline 
We estimate the total time required to complete this study, including recruitment, follow-up and analysis, will be approximately two 
years. 
 
 
H. Study Organization 
Data collection will be managed by the study coordinator at each site, and overseen by the lead site at Boston Children’s 
Hospital. The Clinical Effectiveness Research Center in the Orthopaedic Surgery department at Boston Children’s Hospital will 
be used as a central location for data management, using REDCap (Research Electronic Data Capture) as the primary receptacle 
of our data management. REDCap is a software toolset and workflow methodology for electronic collection and management of 
research and clinical trial data. The REDCap system provides secure, web-based applications that are flexible enough to be used 
for a variety of types of research, provide an intuitive interface for users to enter data and have real time validation rules (with 
automated data type and range checks) at the time of entry. These systems offer easy data manipulation with audit trails for 
reporting, monitoring and querying patient records, and an automated export mechanism to common statistical packages (SPSS, 
SAS, Stata, R/S-Plus).  
 
REDCap servers are housed in a local data center at Boston Children’s Hospital and all web-based information transmission is 
encrypted. REDCap was developed specifically around HIPAA-Security guidelines. REDCap has been disseminated for use 
locally at other institutions and currently supports 240+ academic/non-profit consortium partners on six continents and over 26,000 
research end-users (www.project-redcap.org). 
 
In addition, data collected will be recorded in such a manner (coded) that subjects will not be identified. The key code and all 
study documents with coded data (such as case report forms) will be stored in a locked cabinet file and/or password-protected 
computer file in an access controlled office only accessible to research personnel. Information about study subjects will be kept 
confidential and managed according to the requirements of the Health Insurance Portability and Accountability Act of 1996 
(HIPAA). 
 
 


PI: Michael Glotzbecker, MD 
Page 5 
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PI: Michael Glotzbecker, MD 
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ICF_003.pdf: 
Protocol Title: Bacterial Wound Contamination 
Prior to Closure: Povidone-Iodine versus Saline 
Irrigation in Pediatric Spine Fusion Surgery
Principal Investigator: Michael Glotzbecker MD
RESEARCH CONSENT FORM
Use Plate or Print:
MRN#:
DOB:
Subject’s Name: 
Gender:
Page 1 of 9
Please check one of the following:
_____ You are an adult participant in this study.
_____ You are the parent or guardian granting permission for a child in this study.
If the participant is a child the use of "you" refers to "your child".
This consent form gives you important information about a research study.  A research study helps scientists 
and doctors learn new information to improve medical practice and patient care.
Participation in this research study is voluntary. You are free to say yes or no and your decision will not impact 
the care you receive at Boston Children’s Hospital. You can withdraw from the study at any time.  A 
description of the study and its risks, potential benefits and other important information are in this consent form.  
Please read this consent form carefully and take your time making a decision. The form may contain words that 
you do not understand. Please ask questions about anything you do not understand. We encourage you to talk to 
others (for example, your friends, family, or other doctors) before you decide to participate in this research 
study.   
How are individuals selected for this research study? How many will participate?
We are inviting you to participate in this study because you are between the ages of 3 to 18, have a diagnosis of 
spinal deformity and are undergoing elective posterior spine instrumentation surgery.
Why is this research study being conducted? 
In this research study, we want to learn more about how effectively povidone-iodine (disinfectant that has been 
shown to reduce the number of bacteria present on human tissue) can reduce the number of bacteria in a 
surgical wound compared to the sterile saline solution (sterile salt water).
For many years, povidone-iodine has been used to disinfect the outer surface of the skin, and disinfect the 
wounds of heart, chest, lung, genital, and urinary surgeries. We want to know if povidone-iodine is more 
effective than sterile saline at lowering the number of bacteria in spine fusion surgery.
Who is conducting this research study, and where is it being conducted?
You are being asked to participate in a multi-center research study conducted in Boston, Philadelphia, and 
Kansas City.  At Boston Children’s Hospital, the principal investigator of the study is Dr. Michael Glotzbecker 
of the Division of Spine Surgery in the Department of Orthopedics. The study is sponsored by a Shore 
Foundation grant provided by Boston Children’s Hospital. 
Protocol ID:IRB-P00015085
Activation Date:  October 31, 2017
Do Not Use After:  January  27, 2018


RESEARCH CONSENT FORM
MRN: _________________________
Pt Name: ______________________
Page 2 of 9
Your health care provider may be a research investigator for this research and as an investigator, is interested in 
both your clinical welfare and in the conduct of this study.  Before entering this study or at any time during the 
research, you may ask for a second opinion about your care from another health care provider who is in no way 
associated with this project. You are not under any obligation to participate in any research project offered by 
your health care provider. If you choose not to participate or not to allow your child to participate, your care at 
Boston Children’s Hospital and/or with your health care provider will not be affected in any way at all.
How many people will participate in this research study?
Approximately 150 people will take part in this study at the three different hospitals, and approximately 100 
people will take part at Boston Children’s Hospital. 
What do I have to do if I am in this research study?
As part of your clinical care, you have agreed to undergo an elective posterior spine instrumentation surgery.  
Once the surgery has been performed, we will collect a first sample by swabbing the wound, or removing a 
small piece of tissue, according to the hospital’s routine surgical pathology guidelines, before it is washed out 
and closed, in order to find out how much bacteria is present. 
A spine fusion wound is typically washed out with sterile saline (sterile salt water) or povidone-iodine 
(disinfectant that has been shown to reduce the number of bacteria present on human tissue). If you participate 
in the study, your wound will be washed out with 1) povidone-iodine or 2) sterile saline. 
Because no one knows whether povidone-iodine or sterile saline is best, you will be “randomized” into one of 
the two study groups. Randomization means that you are put into a group by chance. It is like flipping a coin.  
You will have an equal chance of being placed in either group. One group will receive povidone-iodine, and one 
group will receive sterile saline.  Neither you nor the research investigator can choose what group you will be 
in.
Since the expectations of patients can influence the results of a study, you will not know which type of wash-out 
you get until the study is over. But, if there is an emergency, your doctor will be able to get this information.
After the wound is washed out with povidone-iodine or sterile saline, we will collect another sample by 
swabbing the wound, or removing a small piece of tissue, according to the hospital’s routine surgical pathology 
guidelines.  This sample will be done in order to compare how well the povidone-iodine and saline, or sterile 
saline reduced the number of bacteria.  The clinical treatment after the second sample is considered standard 
practice.
In addition, the research study will collect demographic, antibiotic usage, medical history, and surgical data, 
including but not limited to: gender, race, diagnosis, height, weight, surgical time, and blood loss. The outcome 
of your spine fusion surgery will be followed for up to two years, and any complications you have will be noted.
The assignment of the wash-out (povidone-iodine and saline, or sterile saline) and swabbing or tissue collection 
are considered research.  The spine instrumentation surgery and treatment is considered standard of care, and 
Protocol ID:IRB-P00015085
Activation Date:  October 31, 2017
Do Not Use After:  January  27, 2018


RESEARCH CONSENT FORM
MRN: _________________________
Pt Name: ______________________
Page 3 of 9
the data that we are collecting for the research study are from your medical record.  No other procedures will be 
necessary for the research. 
Study Protocol Summary:
Surgery
Surgical wound wash with
povidone-iodine, or sterile saline 
X 
Bacteria Swab or Tissue Collection
X
What are the risks of this research study? What could go wrong?
If your surgical wound is washed with povidone-iodine and saline, it is possible that trace amounts of iodine 
could remain in the wound and increase the amount of iodine in your blood. 
We will swab or collect tissue from your surgical wound before and after it is washed with your assigned 
solution. As part of clinical care, all patients are given antibiotics for the first 24 hours following surgery. These 
antibiotics treat most types of bacteria and, for this reason, even if any of your wound samples test positive for 
bacteria, we will note it in your medical record but we will not treat you.  This is standard practice and you 
would only be treated by your surgeon if there were clinical signs of an infection. 
All research study data will remain private and secured at all times; however, you should be aware that despite 
all safeguarding efforts a breach of confidentiality is possible.
In addition you should be aware that participating in a research study may have risks that are currently 
unforeseeable and that additional costs could result from participation (eg. extended hospitalization). 
What are the benefits of this research study?
Being in this research may not help you right now.  In the future, this research study may benefit children who 
undergo surgical procedures. If povidone-iodine is found to be more effective at reducing the number of 
bacteria in a wound, then fewer patients’ wounds will become infected.
Are there costs associated with this research study? Will I receive any payments?
Patients who participate in this study will receive no monetary compensation or reimbursement.
Although research funds will pay for the testing of the swabs or tissues during your elective posterior spine 
instrumentation surgery, we may bill your health insurer for routine items and services you would have received 
even if you did not take part in this research.  You will be responsible for payment of any deductibles and co-
payments required by your insurer for this routine care or other billed care.  If you have any questions about 
costs to you that may result from taking part in the research, please speak with the research staff.  
In the event of an injury resulting directly from your participation in this research study, medical treatment will 
be provided if the injury is reported in a timely manner.  Provision of such medical care does not imply any 
negligence or other wrongdoing on the part of the Hospital or any of the physicians or other personnel involved 
in the study.  Where applicable, the Hospital reserves the right to seek payment from third-party payers for any 
Protocol ID:IRB-P00015085
Activation Date:  October 31, 2017
Do Not Use After:  January  27, 2018


RESEARCH CONSENT FORM
MRN: _________________________
Pt Name: ______________________
Page 4 of 9
medical care or services rendered.  The Hospital has no program to provide you with any additional 
compensation as a result of any such injuries.
    
If I do not want to take part in this research study, what are the other choices?
Participation in this study is voluntary. If you do not want to take part in this research study, your wound will be 
washed out according to your doctor’s clinical judgment before it is closed up. 
At Boston Children’s Hospital, washing out wounds with povidone-iodine or sterile saline is standard care. 
Surgeons at other institutions use sterile saline, povidone-iodine, chlorhexidine gluconate, soap, or bacitracin. 
Since no method has yet been proven best, this study will compare the effectiveness of two options.
Note that your refusal to participate will not interfere with current or future care received at Boston Children’s 
Hospital.
What are my rights as a research participant?
Study participation is voluntary. Refusal to participate or withdrawal from the study will in no way affect the 
medical care patients receive at Boston Children’s Hospital. Participants will be able to know the results of the 
study once they have been published.
Why would I be taken off the study early?
Anticipated circumstances under which your participation will be terminated by the investigator without regard 
to your consent include:

The study loses funding.

You fail to follow the study requirements.

You need a treatment or medication that may not be taken while on the study or the Principal 
Investigator feels it is in your best interest to be taken out of this study.

Withdrawal of parent/guardian permission.
Other information that may help you
Boston Children’s Hospital has recently developed a web-based, interactive educational program for parents 
called “A Parent’s Guide to Medical Research.”  To find out more about research at Children’s Hospital, please 
visit the program at www.researchchildren.org. 
Boston Children’s Hospital is interested in hearing your comments, answering your questions and responding to 
any concerns regarding clinical research at Children's Hospital. If you would like further information about the 
type of clinical research performed at the hospital or have suggestions, questions or concerns regarding clinical 
research you may send an email to cci@childrens.harvard.edu or call 617 355-7052 between the hours of 8:30 
and 5:00.
Who may see, use or share your health information? 
A copy of this consent form will be placed in your medical record.  If you do not have a medical record at 
Boston Children’s Hospital, one will be created for you.
Protocol ID:IRB-P00015085
Activation Date:  October 31, 2017
Do Not Use After:  January  27, 2018


RESEARCH CONSENT FORM
MRN: _________________________
Pt Name: ______________________
Page 5 of 9
Medical information collected during this study will become part of your hospital record, including: bacteria 
present before and after washout with povidone-iodine or sterile saline (presence and type, if applicable)
Medical records are considered permanent records; therefore, materials cannot be deleted from the record.  
Medical records are available to health care professionals at Children's Hospital and may be reviewed by 
Hospital staff in their course of carrying out their responsibilities; however, they are required to maintain 
confidentiality in accordance with applicable laws and Hospital policies.  Information contained in your/your 
child's medical record may not be given to anyone unaffiliated with Children's Hospital in a way that could 
identify you/your child without written consent, except as required or permitted by law. Information collected 
during the study that does not become part of your/your child's medical record will be stored in separate 
research files maintained by the investigator.  These research records will not be made available to any 
individuals who are not part of the research team unless you so request or as required by law. If you/your child 
withdraw from the research study, information that has already been collected will become part of the research 
data; however, you/your child will not be identified.
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. law.  
This Web site will not include information that can identify you.  At most, the Web site will include a summary 
of the results. You can search this Web site at any time.
What should you know about HIPAA and confidentiality?
You/your child’s health information is protected by a law called the Health Information Portability and 
Accountability act (HIPAA). In general, anyone who is involved in this research including those funding and 
regulating the study may see the data, including information about you.  For example, the following people 
might see information about you:

Research staff at Boston Children’s Hospital involved in this study.

Medical staff at Boston Children’s Hospital directly involved in your care that is related to the research 
or arises from it.

Other researchers and centers that are a part of this study, including people who oversee research at that 
hospital.

People at Boston Children’s Hospital who oversee, advise, and evaluate research and care. This includes 
the ethics board and quality improvement program.

People from agencies and organizations that provide accreditation and oversight of research.

People that oversee the study information such as data safety monitoring boards, clinical research 
organizations, data coordinating centers, and others. 

Sponsors or others who fund the research, including the government or private sponsors.

Companies that manufacture drugs or devices used in this research.

Federal and state agencies that oversee or review research information, such as the Food and Drug 
Administration, the Department of Health and Human Services, the National Institutes of Health, and 
public health and safety authorities.

People or groups that are hired to provide services related to this research or research at Boston 
Children’s Hospital, including services providers, such as laboratories, and others.

Your health insurer for portions of the research and related care that are considered billable.
Protocol ID:IRB-P00015085
Activation Date:  October 31, 2017
Do Not Use After:  January  27, 2018


RESEARCH CONSENT FORM
MRN: _________________________
Pt Name: ______________________
Page 6 of 9
If some law or court requires us to share the information, we would have to follow that law or final ruling.
Some people or groups who get your health information might not have to follow the same privacy rules. Once 
your information is shared outside of Boston Children’s Hospital, we cannot promise that it will remain private. 
If you/your child decide to share private information with anyone not involved in the study, the federal law 
designed to protect privacy may no longer apply to this information. Other laws may or may not protect sharing 
of private health information. If you have a question about this you may contact the Boston Children’s Hospital 
Privacy Office at 857-218-4680 which is set up to help you understand privacy and confidentiality.
Because research is ongoing we cannot give you an exact time when we will destroy this information.  
Researchers continue to use data for many years so it is not possible to know when they will be done.
We will also create a code for the research information we collect about you so identifying information will not 
remain with the data and will be kept separately. The results of this research may be published in a medical 
book or journal or be used for teaching purposes. However your name or identifying information will not be 
used without your specific permission. 
Your privacy rights
If you or your child do not want to participate in this study, you do not have to.  If you do want to participate, 
however, you must sign this form.  
If you do not sign this form, it will not affect your care or your child’s care at Boston Children’s Hospital now 
or in the future and there will be no penalty or loss of benefits.  You/your child can withdraw from the study 
and end your permission for Boston Children’s Hospital to use or share the protected information that was 
collected as part of the research; however you cannot get back information that was already shared with others. 
Once you remove your permission, no more private health information will be collected. If you wish to 
withdraw your health information will need to do so in writing.  
You/your child may have the right to get some the information that was shared with others for research, 
treatment or payment.  This information is available after the study analysis is done.  To request the 
information, please contact the Hospital’s Privacy Officer at 857-218-4680.
Contact Information
I understand that I may use the following contact information to reach the appropriate person/office to address 
any questions or concerns I may have about this study.  I know:
Protocol ID:IRB-P00015085
Activation Date:  October 31, 2017
Do Not Use After:  January  27, 2018


RESEARCH CONSENT FORM
MRN: _________________________
Pt Name: ______________________
Page 7 of 9
  I can call…
 At
 If I have questions or concerns about
Investigator
Phone:
(617) 355-4847
Michael Glotzbecker
Pager:
4583
 General questions about the study
 Research-related injuries or emergencies
 Any research-related concerns or complaints
Research Coordinator
Phone:
(617) 919-1633
Pager:
8351
 General questions about the study
Research-related injuries or emergencies
 Any research-related concerns or complaints
Office of
Clinical Investigations
Phone:
617-355-7052
Rights of a research subject
Use of protected health information.
Compensation in event of research-related injury
Any research-related concerns or complaints.
If investigator/study contact cannot be reached.
If I want to speak with someone other than the 
Investigator, Study Contact or research staff.
Documentation of Informed Consent and Authorization
I have read this consent form and was given enough time to consider the decision to participate in this study.
This research study has been satisfactorily explained to me, including possible risks and benefits.
All my questions were satisfactorily answered. 
I understand that participation in this research study is voluntary and that I can withdraw at any time.
I am signing this consent form prior to participation in any research activities.
I give permission for my/my child’s participation in this research study and for the use of associated protected health 
information as described above (HIPAA). 
Parent/Legal Guardian Permission (if applicable) 
If the child to be involved in this research study is a foster child or a ward of the state please notify the researcher or their 
staff who is obtaining your consent.
 __________________
____________________________________________
_________________ 
  Date (MM/DD/YEAR)
Signature of Parent #1 or Legal Guardian
Relationship to child
Child Assent (if applicable) 
__________________
____________________________________________
   Date (MM/DD/YEAR)
Signature of Child/Adolescent Subject
If child/adolescent’s assent is not obtained above, please indicate reason below (check one):
 Assent is documented on a separate IRB-approved assent form
Protocol ID:IRB-P00015085
Activation Date:  October 31, 2017
Do Not Use After:  January  27, 2018


RESEARCH CONSENT FORM
MRN: _________________________
Pt Name: ______________________
Page 8 of 9
 Child is too young
 Other reason (e.g. sedated), please specify: ____________________________________________
Adult Subject (if applicable) 
__________________
____________________________________________
   
Date (MM/DD/YEAR)
Signature of Adult Subject (18+ years)
ADULT SUBJECT - if decisionally impaired (if applicable) 
Legal Authorized Representative/Guardian
I give permission for the person I am authorized to represent to participate in this research study and for the use of 
associated protected health information as described above (HIPAA). 
 __________________
____________________________________
__________________________
  Date (MM/DD/YEAR)
Signature of Legal Guardian
Print Name
Relationship to Subject * (This order must be followed. If there is a court appointed guardian, this is who needs to 
provide consent. If not, a health care proxy, followed by durable power of attorney and lastly, family members)
 Court-Appointed Guardian
 Health Care Proxy (Attach Proxy and ensure there is express authority to make health care decisions inclusive of 
research.)
 Durable Power of Attorney (POA) (Durable POA may be limited to specific areas. Attach Durable POA and ensure 
it covers research.)
 Family Member/Next of Kin, (in order of preference: spouses, parents and adult children) 
     Specify relationship___________________________  
 
Adult Assent (if applicable) 
__________________
____________________________________________
   Date (MM/DD/YEAR)
Signature of Adult Subject  
CHECK if Adult Subject’s assent not obtained above, and specify reason below:
____________________________________________________________
Investigator or Associate’s Statement & Signature
I have fully explained the research study described above, including the possible risks and benefits, to all involved 
parties (subject/parents/legal guardian as applicable). 
I have answered and will answer all questions to the best of my ability. 
I will inform all involved parties of any changes (if applicable) to the research procedures or the risks and benefits 
during or after the course of the study. 
Protocol ID:IRB-P00015085
Activation Date:  October 31, 2017
Do Not Use After:  January  27, 2018


RESEARCH CONSENT FORM
MRN: _________________________
Pt Name: ______________________
Page 9 of 9
I have provided  a copy of the consent form sign by the subject/ parent / guardian and a copy of the hospital’s 
privacy notification  (if requested)
__________________ ____________________________________________
   Date 
(MM/DD/YEAR)
Signature of Investigator or Associate
Witness Statement & Signature
A witness must be present for the entire consent process in the following situations (please check the appropriate 
box) 
 The individual cannot read and this consent document was read to the subject or legal representative, or
 The individual has certain communication impairments that limit the subject’s ability to clearly express 
consent or 
: Situations where the IRB requests a witness be present: please specify _____________________
 I confirm that the information in this consent form was accurately explained to the subject, parent or legally 
authorized representative, the individual appeared to understand the information and had the opportunity to ask 
questions, and that informed consent was given freely.
   __________________          ____________________________________________             
        Date (MM/DD/YEAR)              Signature of Witness
Or   
The individual is not English speaking and, through an interpreter, a short form consent document was 
presented orally to the subject or legal representative and this consent document serves as the summary for such 
consent.  
I confirm that the information in this consent form was presented orally to the subject, parent or legally 
authorized representative, in a language they could understand and the individual had the opportunity to ask 
questions.
   __________________          ____________________________________________             
        Date (MM/DD/YEAR)              Signature of Witness and Interpreter 
Protocol ID:IRB-P00015085 
Activation Date:  October 31, 2017 
Do Not Use After:  January  27, 2018