Clinical trial NCT03756506: The Use of a Novel Microbicidal Liquid Polymer for the Reduction of Pin Track Infection
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infection
Post-operative Care
Lead sponsor: Prevent-Plus LLC
Sponsor class: INDUSTRY
First posted: 2018-11-28
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study will enroll 12 total research participants (6 control research participants and 6 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 a Novel Microbicidal Liquid Polymer 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.
Primary purpose: PREVENTION

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.

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.)

Primary outcomes:
measure: Pin Track Infection Rate Among Research Participants Based on Number of Pins Undergoing Deformity Correction and Traumatic Provisional Fixation
timeFrame: 10 months
measure: Pin Track Infection Rate Among Research Participants Undergoing Deformity Correction and Traumatic Provisional Fixation
timeFrame: 10 months
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Julie Morris
state: Missouri
Study officials:
affiliation: Kettering Health System
name: Shital Pema, DPM
role: PRINCIPAL_INVESTIGATOR
References: