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

NCT ID: NCT03756506

Last Updated: 2021-03-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-07
• Study Completion Date: 2019-09-30

Brief Summary

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.

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.

Conditions

Infection; Post-operative Care

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Novel Microbicidal Liquid Polymer

Intervention Type: DEVICE

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Prevent-Plus LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shital Pema, DPM

Role: PRINCIPAL_INVESTIGATOR

Kettering Health System

Locations

Julie Morris

St Louis, Missouri, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2018-01

Identifier Type: -

Identifier Source: org_study_id