Study on the Reapplication of Chloraprep After Lower Extremity Surgery and Prior to Dressing Application

February 17, 2014 updated by: Kyle Judd, Sanford Health

Role of Post-operative Re-application of Chloraprep® Following Lower Extremity Surgeries on Surgical Site Bacterial Colonization.

The purpose of the current work is to determine the efficacy of the re-application of surgical prep solution in decreasing surgical site bacterial contamination following lower extremity surgery. Decreasing the extent of bacterial colonization of the skin surrounding the surgical site during the initial healing phases would theoretically decrease the rate of infection in high-risk persons.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

140

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57117
        • Recruiting
        • Sanford USD Medical Center
        • Contact:
        • Principal Investigator:
          • Kyle T Judd, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • Male and female
  • Adults (18+)
  • Both elective and non-elective procedures
  • Lower extremity surgery performed below the knee and requiring post-operative splint immobilization for 2-3 weeks
  • Able to understand and read the English language
  • Signed informed consent

Exclusion Criteria:

  • Pregnant (to be assessed the day of surgery per standard of care surgical protocol)
  • Known allergies to chlorhexidine gluconate or isopropyl alcohol
  • Multiple planned lower extremity surgeries
  • Local skin disease
  • Pre-existing or known infection at surgical site
  • Open wounds or local abrasions
  • Unable to or unwilling to follow through with study requirements

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: no reapplication
This group will not have chloraprep reapplied after their surgery and prior to dressing application.
Experimental: reapplication
This group will have chloraprep reapplied following their lower extremity surgical procedure and prior to dressing application.
Drug: Chloraprep

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
quantitative bacterial colonization
Time Frame: 14-21 days
Compare the number of colony forming units taken from culture swabs immediately adjacent to the wound during dressing change between the two arms
14-21 days
positive culture rate
Time Frame: 14-21 days
Compare the overall positive culture rate between the two treatment groups
14-21 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
bacterial strain identification
Time Frame: 14-21 days
Assess the total number of bacterial strains and identifying those strains cultured from swabs taken immediately adjacent to the wound during dressing change
14-21 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanford Health

Investigators

  • Principal Investigator: Kyle T Judd, MD, Sanford Orthopedics and Sports Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Anticipated)

February 1, 2015

Study Registration Dates

First Submitted

December 16, 2013

First Submitted That Met QC Criteria

December 16, 2013

First Posted (Estimate)

December 20, 2013

Study Record Updates

Last Update Posted (Estimate)

February 19, 2014

Last Update Submitted That Met QC Criteria

February 17, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SH Chloraprep reapplication

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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