N/A Completed N=13 Randomized Single-blind Prevention

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

Infections · Post-operative Care

Source: ClinicalTrials.gov NCT03756506 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2020

Primary outcomePrimary: Pin Track Infection Rate Among Research Participants Based on Number of Pins Undergoing Deformity Correction and Traumatic Provisional Fixation — 0; 14 Pins

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Pin Track Infection Rate Among Research Participants Based on Number of Pins Undergoing Deformity Correction and Traumatic Provisional Fixation	0; 14	—
PRIMARY Pin Track Infection Rate Among Research Participants Undergoing Deformity Correction and Traumatic Provisional Fixation	0; 2	—

Eligibility Criteria

Inclusion Criteria

Deformity correction, traumatic provisional fixation
All pin sites are stable
18 years of age or greater
No known contraindication to receive product

Exclusion Criteria

Age less than 18 years
Known allergy to Methylene Chloride
Known sensitivity to organic polymers
Non-clean, dry wound at pin
Vulnerable research participants (Institutionalized, students, employees, prisoners, or those with decisional incapacity, etc.)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03756506). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.