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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Lower Extremity Surgery Surgical Site Infection Bacterial Colonization Surgical Antiseptic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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no reapplication

This group will not have chloraprep reapplied after their surgery and prior to dressing application.

Group Type NO_INTERVENTION

No interventions assigned to this group

reapplication

This group will have chloraprep reapplied following their lower extremity surgical procedure and prior to dressing application.

Group Type EXPERIMENTAL

Chloraprep

Intervention Type DRUG

Interventions

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Chloraprep

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No