The Use of a Novel Microbicidal Liquid Polymer for the Reduction of Pin Track Infection

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

The purpose of the study is to investigate additional clinical uses for the polymer, which is a FDA approved, 510k, medical device, but has not been approved for use on patients with pin track sites as a way to lower the infection rate and is investigational for this purpose. The approved uses include wound care and post-operative care.

About 13 subjects will take part in this study.

Study Overview

• Status: Completed
• Conditions: Infection; Post-operative Care
• Intervention / Treatment: Device: Novel Microbicidal Liquid Polymer

Detailed Description

Study Objectives 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.

It 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. It is for external use only. It 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.7

This Principle Investigator has previously utilized and topically applied the product as an additional step in the treatment protocol for pin site care for several reconstructive surgery patients (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). A recently published retrospective case series evaluating this microbicidal polymer dressing reported 6 patients and 66 pins had no infections when Duraderm® was used as part of their pin site care regimen.8

This study was undertaken to formally evaluate whether this microbial liquid po used on pin sites leads to a reduction in pin track infections when compared to a control group as well as the reported average incidence in the literature.

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Julie Morris

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 product

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.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Novel Microbicidal Liquid Polymer; 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.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. 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. Step 3: Apply product with Q-tip on clean dry wound around (extending approximately one inch around pin site) and on the pin. The Polymer will be applied daily while in the hospital and then at a minimum of at least three times a week until pin removal.	Device: Novel Microbicidal Liquid Polymer; The polymer 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 polymers . The unique formulation eradicates any organisms (bacteria, fungi, viruses) it comes in contact with. This is a result of the solvent's activity against an infinite number of organisms After eradication is complete, the solvent then transitions into a clear, elastomeric, non-odorous film for covering disrupted tissue. 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.6 DuraDerm® should not be used to the treat deep infected wounds. DuraDerm® can be used to protect disrupted skin surface of wounds that are clean and dry.
No Intervention: Control group: no Novel Microbicidal Liquid Polymer; The usual care of pin track sites will be followed as outlined belowAll 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. 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. 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pin Track Infection Rate Among Research Participants Based on Number of Pins Undergoing Deformity Correction and Traumatic Provisional Fixation	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®.	10 months
Pin Track Infection Rate Among Research Participants Undergoing Deformity Correction and Traumatic Provisional Fixation	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®.	10 months

Collaborators and Investigators

• Sponsor: Prevent-Plus LLC
• Investigators: Principal Investigator: Shital Pema, DPM, Kettering Health System

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2018
• Primary Completion (Actual): September 30, 2019
• Study Completion (Actual): September 30, 2019

Study Registration Dates

• First Submitted: November 26, 2018
• First Submitted That Met QC Criteria: November 26, 2018
• First Posted (Actual): November 28, 2018

Study Record Updates

• Last Update Posted (Actual): March 30, 2021
• Last Update Submitted That Met QC Criteria: March 8, 2021
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases
• Other Study ID Numbers: 2018-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No