An Evaluation of the Use of a Novel Microbicidal Liquid Polymer for the Reduction of Pin-tract Infection in Research Participants Receiving External Fixation Following Deformity Correction and Traumatic Provisional Fixation
Phase: NA
Conditions: Infection, Post-operative Care
Sponsor: Prevent-Plus LLC

Prevent-Plus, LLC  
           Study Protocol #2018-01                                       Date: 06/2018 
 
 
  
 Page 1 of 8 
 
 
An Evaluation of the Use of DuraDerm® for the Reduction of Pin Track 
Infection in Research Participants Receiving External Fixation 
Following Deformity Correction and Traumatic Provisional Fixation  
 
Study Principal Investigator: Shital Pema, DPM 
 
 
Purpose of the Study 
 
The purpose of this study is to determine if DuraDerm®, a medical device having novel 
technology, leads to a reduction in pin track infection rate (compared to the average 
prevalence reported in the literature) when applied as part of a pin track care protocol. 
 
Background 
 
Metal pins are commonly used for external fixation in research participants undergoing 
reconstructive or repair surgery. These pins protrude through the skin and create an 
avenue for migration of organisms. Anytime there is a break in the integrity of the skin, 
the risk of infection is increased. Pin site infections are a very common complication of 
external fixation, and unfortunately, the literature is scant on how to optimally minimize 
the risk of infection. 
 
A Cochrane Collaboration Review published in 2004 to assess the effect on infection 
rates of different methods of cleaning and dressing orthopedic percutaneous pin sites 
determined that there was little evidence as to which pin site care regimen best reduces 
infection rates.1 
 
Depending on the reference, pin track infections rates have been reported to range from 
0% to 100%. A systematic review of the incidence of pin track infections associated with 
external fixation published in 2016 revealed a cumulative pin track infection rate of 27%. 
This rate was defined as the inherent risk of any given research participant developing a 
pin track infection at a random pin or wire site during the course of treatment with 
external fixation.2 A 2016 review describes pin track infection as the most commonly 
expected problem, or even an almost inevitable complication, when using external 
fixation.3 
 
Several limitations of the current literature pose significant barriers to the study of pin 
site infection preventative strategies.4 Limitations include: 
 
1. Lack of uniform definition/criteria to diagnose and classify severity of pin track 
infections. This makes it difficult to define the true incidence. 
2. Highly variable control groups between studies. This creates difficulty in applying 
study results to an individual practice or protocol for preventative care. 
3. Within studies, treatment groups often differ by more than one variable (e.g. 
changing both the cleaning solution and dressing type). This makes it impossible 
IRB Conditions 
Satisfied at the Protocol 
Level 
Oct 10, 2018
20182067

Prevent-Plus, LLC  
           Study Protocol #2018-01                                       Date: 06/2018 
 
 
  
 Page 2 of 8 
 
to determine the effect of individual variables and applying study results to an 
individual practice for protocol. 
4. There exists few randomized controlled trials. This creates clinical practice based 
on low quality, underpowered, potentially biased studies. 
5. There is no consistency in reporting infection rate (per patient vs per individual 
pin site). This creates difficulty in studying incidence, comparing studies, or 
conducting an accurate meta-analysis. 
 
Research participants eligible for the study will be those undergoing Deformity 
Correction and Traumatic Provisional Fixation. These research participants have a 
number of pins placed to ensure this required rigid fixation. The number of external 
fixation pins averages approximately ten per research participant.  
 
DuraDerm® is a 510K FDA cleared medical device indicated for providing a covering 
over minor wounds and scrapes that are clean and dry. The microbicidal liquid solution 
consists of organic polymer dissolved in methylene chloride organic solvent. The unique 
formulation eradicates any organisms (bacteria, fungi, viruses) it comes in contact with. 
This is a result of the methylene chloride’s activity against an infinite number of 
organisms. The methylene chloride evaporates leaving a clear, elastomeric, non-odorous 
film for covering minor wounds. The film protects the wound against entry of water, dirt, 
and germs. The film is elastomeric and protects in difficult regions where flexing, 
bending and creasing skin occurs. The clear film forms in less than a minute. Application 
is commonly accomplished using a cotton tip applicator. The liquid is applied on and 
around the wound extending at least an inch and a quarter beyond the edges of the 
wound. Momentary stinging may occur upon initial application. The film commonly 
remains intact for one to three days or longer depending on exposure to rubbing, flexing, 
or soap and water. This film is resistant to degradation by water alone, but can be easily 
removed with the combination of soap and water or it can be gently peeled off starting at 
the outer edges. DuraDerm® is for external use only. DuraDerm® is not intended for use 
on deep or infected wounds or puncture wounds, or for use near the eyes, mouth, or nose. 
Intentional inhaling of the contents may be harmful or fatal. The bottle should be tightly 
capped after each use to prevent evaporation of the solvent.4 
 
The Principle Investigator has utilized topically applied DuraDerm® as an additional step 
in his current treatment protocol for pin site care for several research participants 
(approximately 25) with over 200 pin sites with only 2 pin site infections.   This 
represents a significant reduction from the average incidence of pin site infections 
reported in the literature (<1% vs 27% on a per research participant basis).  
 
This study will be undertaken to formally evaluate whether DuraDerm® used on pin sites 
leads to a reduction in pin track infections when compared to the reported average 
incidence in the literature. 
 
 
 
 

Prevent-Plus, LLC  
           Study Protocol #2018-01                                       Date: 06/2018 
 
 
  
 Page 3 of 8 
 
Criteria for Research Participant Selection 
• 6 research participants with approximately 60 pin sites (average 10/research 
participant) will be enrolled into the study for the Control group receiving 
standard pin track care.  
• 6 research participants with approximately 60 pin sites (average 10/research 
participant) will be enrolled into the study for the DuraDerm® group. These 
research participants will receive the exact same standard pin track care with the 
addition of DuraDerm® applied at each cleaning of the pin track area, as an 
additional step in the pin track care protocol. 
 
The age of research participants was chosen based on the majority of principle 
investigator’s research participants being adults and to avoid any special consideration 
that may apply to research with minors. The study will not be gender specific. There are 
no enrollment restrictions based upon race or ethnic origin.  Study protocol will continue 
post discharge up to 6 to 8 weeks until patient final visit post pin removal.  Proper 
inserving of product was conducted and documented.  
 
Inclusion Criteria: 
1. Deformity correction, traumatic provisional fixation  
2. All pin sites are stable 
3. 18 years of age or greater 
4. No known contraindication to receive DuraDerm® 
 
Exclusion Criteria: 
1. Age less than 18 years 
2. Known allergy to Methylene Chloride 
3. Known sensitivity to organic polymers 
4. Non-clean, dry wound at pin  
5. Vulnerable research participants (Institutionalized, students, employees, 
prisoners, or those with decisional incapacity, etc.)  
 
Methods and Procedures 
 
The study will enroll 12 total research participants (6 control research participants and 6 
DuraDerm® research participants) with approximately 120 pin sites (approximately 60 in 
the Control group and 60 in the DuraDerm® group). Each research participant 
undergoing Deformity Correction and/or Traumatic Provisional Surgery will be asked to 
participate in the study to evaluate if the topical application of DuraDerm® as an 
additional step in the management of post-operative pin track site care reduces the 
incidence of pin track infections. Investigational Review Board (IRB) approval will be 
obtained and informed research participant consent will be obtained from each research 
participant. 
 
For the control group, the usual care of pin track sites will be followed as outlined below 
(Pin Track Care Regimen).  For the DuraDerm® group, the same care regimen will be 
followed with the addition of DuraDerm® applied topically to pin track site as the 

Prevent-Plus, LLC  
           Study Protocol #2018-01                                       Date: 06/2018 
 
 
  
 Page 4 of 8 
 
experimental procedure being performed for research purposes. No additional tests or 
procedures outside of the existing standard regimen currently being utilized are 
anticipated.  
 
Pin Track Care Regimen 
 
Control and DuraDerm® Groups 
All pins and wire sites will be cleaned daily while hospitalized. Basic pin care will be 
performed once daily by hospital nursing staff prior to discharge.  Following discharge 
from the hospital, the pin care protocol will be continued by research participant’s 
caregiver.  
Ideally, pin sites are cleaned when the surrounding skin and gauze are soft. This should 
make removal of gauze and cleaning of pins less painful. The purpose of the cleaning is 
to prevent the skin from attaching to the pins and wires and to decrease the chance of 
infection, as well as, inspect the area for any signs of infection. 
Research participants will be instructed to notify the Principal Investigator if they observe 
any signs or symptoms of infection. These include redness around pin site, discharge, 
tenderness in the soft tissue, loosening of the pin, nausea, vomiting, fever or chills. 
Research participants will be instructed that the approach to pin care should occur in a 
step-wise fashion.  If Step 1 is effective there is no need for further debris removal and 
research participants will be instructed conclude the care protocol (Control Group) or 
proceed to Step 3 (DuraDerm® group). Basically, if Step 1 removes all debris, Steps 2 is 
not necessary. It is not uncommon for all of Steps 1 and 2 to be needed to completely 
remove debris.  
Step 1: 
Brush the pin sites with saline using an ordinary soft toothbrush or gauze 
with sterile gloves 
Step 2:           If following Step 1, debris remains, use forceps (tweezers) to gently remove 
debris. 
DuraDerm® Group (IDENTICAL CARE AS DESCRIBED ABOVE + Step 3) 
 
Step 3: 
Apply DuraDerm® with Q-tip on clean dry wound around (extending 
approximately one inch around pin site) and on the pin.  DuraDerm® will 
be applied daily while in the hospital and then at a minimum of at least 
three times a week until pin removal. 

Prevent-Plus, LLC  
           Study Protocol #2018-01                                       Date: 06/2018 
 
 
  
 Page 5 of 8 
 
DuraDerm® should be reapplied at the end of each Pin Care Cleaning 
Regimen. 
 
See Attachment – Schedule of Events 
 
Data Analysis and Data Monitoring 
 
This is a prospective observational case series study to measure the potential reduction in 
pin track infection rate among research participants undergoing Deformity Correction and 
Traumatic Provisional Fixation. 
 
Data will be collected by clinical staff under supervisor of the Principal Investigator. Data 
collected is primarily categorical and will be analyzed using tabulations (tables of 
frequencies), visual displays (histograms), and chi-square or Fisher exact tests to measure 
variable independence (e.g., infection rate based on age, number of pins/research 
participants, etc.). 
 
Data Storage and Confidentiality 
 
Data will be stored on Principle Investigator’s computer which is secured by password 
protection. A hard copy backup with also be kept and be stored in a locked cabinet or 
office with limited access. Confidentiality will be maintained by assigning each research 
participant a unique research participant identifier. Research participant identifier will 
consist of research participant’s initials and date of birth.  Raw data will not be shared 
with anyone. Tabulated data with confidential research participant identifiers will only be 
shared with study coordinator and statistician.  
 
Risk/Benefit Assessment 
 
Risk Category 
 
This research study presents minimal risk to the research participant. DuraDerm® has 
been used by over 3,000 individuals without any reported serious side effects 
 
 
 
 
Potential Risk 
 
The most common side effect of DuraDerm® is momentary stinging upon application. 
Intentional inhalation of the contents may be harmful or fatal. The product should be used 
with adequate ventilation. DuraDerm® should be kept away from children and not used 
near the eyes, mouth, or nose. The solution may be damaging to clothes or finished 
surfaces. If ingested, obtain medical assistance immediately. If used as directed, the 
probability of any potential risk is minimal. Since this study is being conducted on 

Prevent-Plus, LLC  
           Study Protocol #2018-01                                       Date: 06/2018 
 
 
  
 Page 6 of 8 
 
extremity pin tracks, the application with be of significant distance from the eyes, mouth 
or nose. The only foreseen risk form the application of DuraDerm® on pin track sites is 
momentary stinging and this is not a consistent risk.  
 
Protection Against Risk 
 
All research participants will be monitored for potential redness or irritation at the pin 
track sites, and if any occurs, discontinuation of application may be warranted if it is 
believed to be a result of a reaction to the product.  Any significant adverse event will be 
reported to the FDA utilizing FDA Medwatch Form 3500. 
 
Potential Benefit to the Research participants 
 
Since the infection rate of pin track research participants is approximately 27%, and 
initial information provided by the principle investigator indicates a much lower pin track 
infection rate, the benefit of reduced infection appears to significant.  
 
Alternatives to Participation 
 
Should a research participant elect not to participate in the study, they will receive 
standard pin track site care as described for the control group. 
 
Research participant Identification, Recruitment and Consent Form 
 
Method of Research Participant Identification, Recruitment and Consent/Assent 
 
Research participants identified for the study will be those undergoing Deformity 
Correction and Traumatic Provisional Fixation who are under the care of the Primary 
Investigator. These research participants have a number of pins placed to ensure this 
required rigid fixation. The number of external fixation pins averages approximately ten 
per research participant. Research participants seen by the Primary Investigator who will 
be undergoing deformity correction or traumatic provisional fixation, will be invited to 
take part in this research study. No recruitment of the Principal Investigator’s own 
students, employees, or family members will be allowed. Research participants who do 
not wish to participate in this randomized study will be provided the standard pin track 
care protocol this investigator utilizes for his research participants and will not have the 
opportunity to receive DuraDerm®. 
 
 
Process of Consent 
 
The Primary investigator and other key personnel on the study (fellow, nursing staff, 
intake coordinator and others) will be authorized to obtain consent from potential 
research participants for inclusion in the study. The process will be structured to present 
to the research participants the option to take part in this research that is intended to 
provide more conclusive information on the ability of DuraDerm®, a new liquid polymer 

Prevent-Plus, LLC  
           Study Protocol #2018-01                                       Date: 06/2018 
 
 
  
 Page 7 of 8 
 
technology to reduce pin track infections. The potential research participants will be 
provided the consent form and this information will be explained to them. It will be made 
clear that participation in the study is completely voluntary and if they do not choose to 
take part in the study, they will receive the usual pin track standard of care provided by 
the Primary Investigator. The Primary Investigator or authorized team member will be 
responsible for signing as witness of consent being given. 
 
Research Participant Capacity 
 
All research participants will have the capacity to provide informed consent. If a research 
participant presenting to the Primary Investigator’s practice, is not able to provide 
informed consent, they will not be presented the opportunity to take part in the study. 
 
Research Participant/Representative Comprehension 
 
If a research participant has been determined to be eligible for study participation based 
on the inclusion/exclusion criteria, they will be provided with the consent form and the 
information within the consent form will be discussed. Only those research participants 
indicating they understand the risks and benefits of receiving DuraDerm® as part of their 
pin track care protocol in the study and stating clearly that they would like to voluntarily 
participate, will be given the opportunity to take part in the study. 
 
Debriefing Procedures 
 
No information will be purposely withheld from the study research participants. 
 
Consent Form 
 
See attached. 
 
Documentation of Consent 
 
Consent will be documented on an individual consent for each research participant. These 
forms will be kept in a secure file cabinet in the Principal Investigator’s office. 
 
Cost to Research Participants 
 
Research participants in this study will incur no additional costs for participation in the 
study. All DuraDerm® will be provided at no cost to the research participants in the 
DuraDerm® treatment group. No additional charges other than those normally occurring 
under the standard pin track care protocol will occur. All DuraDerm® will be provided 
by Prevent-Plus, LLC, the patent holder of DuraDerm®. 
 
Payment for Participation 
 

Prevent-Plus, LLC  
           Study Protocol #2018-01                                       Date: 06/2018 
 
 
  
 Page 8 of 8 
 
No payment or any other type of reimbursement will be provided to the research 
participants in this study.  
 
See Consent Form – Attachment 1 
 
See Data Collection Sheet –Attachment 2 
 
References: 
 
1. Temple J, Santy J. Pin site care for preventing infections associated with external 
bone fixators and pins. Cochrane Database of Systematic Reviews 2004, Issue 1. 
Art. No.:CD004551. DOI: 10.1002/14651858.CD004551. 
2. lobst CA, Liu RW. A systematic review of incidence of pin track infections 
associated with external fixation. J Limb Lengthen Reconstr 2016;2:6-16. 
3. Ceroni D, et al. From Prevention of pin-tract infection to treatment of 
osteomyelitis during paediatric external fixation. J Child Orthop 2016;10:605-
612. 
4. Kazmers NH, et al. Prevention of pin site infection in external fixation: a review 
of the literature. Strat Traum Limb Recon 2016;11:75-85. 
5. Sammarco VJ. Superconstructs in the treatment of Charcot foot deformity: plantar 
plating, locked plating, and axial screw fixation. Foot Ankle Clin 2009;14(3):393-
407.