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 The leading web portal for pharmacy resources, news, education and careers December 19, 2018
Pharmacy Choice - Pharmaceutical News - 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 - December 19, 2018

Pharmacy News Article

 12/6/18 - 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

By a News Reporter-Staff News Editor at Clinical Trials Week Staff editors report on the newly launched clinical trial, NCT03756506, which has the following summary description: "The purpose of the study is to investigate additional clinical uses for DuraDerm. DuraDerm 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 20 subjects will take part in this study."

As a matter of record, on November 29, 2018, NewsRx staff editors report that the available information provided by Prevent-Plus LLC on this trial include:

Tracking Information

Trial IdentifierNCT03756506
First Submitted DateNovember 26, 2018
First Posted DateNovember 28, 2018
Results First Submitted DateNot Provided
Results First Posted DateNot Provided
Last Update Submitted DateNovember 26, 2018
Last Update Posted DateNovember 28, 2018
Primary Completion DateApril 30, 2019
Actual Start DateNovember 7, 2018
Current Primary Outcome Measures?This is a 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 [ Time Frame: 6 months ] 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.
Current Secondary Outcome MeasuresNot Provided
Other Outcome MeasuresNot Provided
Change Historyhttps://clinicaltrials.gov/archive/NCT03756506 - Complete list of historical revisions of study NCT03756506

Descriptive Information

Brief TitleDuraDerm for the Reduction of Pin Track Infection
Official TitleAn 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
Brief SummaryThe purpose of the study is to investigate additional clinical uses for DuraDerm. DuraDerm 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 20 subjects will take part in this study.
Detailed DescriptionNot Provided
Study TypeInterventional
Study PhaseN/A
Study DesignAllocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
Masking: Single
Intervention Model Description: 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.
ConditionInfection
Post-operative Care
Intervention?Device: DuraDerm
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 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.
Study Arms?Active Comparator: DuraDerm Group
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 con
Interventions:
?Device: DuraDerm

Recruitment Information

Recruitment StatusRecruiting
Estimated Enrollment12
Estimated Completion DateJune 30, 2019
Primary Completion DateApril 30, 2019 (Final data collection date for primary outcome measure)
EligibilityInclusion 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.)
Sex/GenderSexes Eligible for Study: All
Ages18 years and older
Accepts Healthy VolunteersYes
ContactsPrimary contact: Jeff ElBL, PharmD, 3146065046, jeff.elbl@prevent-plus.com
Backup contact: Julie Morris, 3146033066, jmorris@prevent-plus.com
Listed Location CountriesUnited States
Removed Location Countries

Administrative Information

NCT NumberNCT03756506
Other Study ID Numbers2018-01
Has Data Monitoring CommitteeYes
U.S. FDA-regulated ProductStudies a U.S. FDA-Regulated Drug Product: No
Studies a U.S. FDA-Regulated Device Product: Yes
Plan to Share Data (IPD) DescriptionNot Provided
Responsible PartyPrevent-Plus LLC
CollaboratorsNot Provided
InvestigatorsPrincipal Investigator: Shital Pema, DPM, Kettering Health System
Information Provided ByPrevent-Plus LLC
Verification DateNovember 2018

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