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

Phase 4

• Conditions: Lower Extremity Surgery; Bacterial Colonization; Surgical Site Infection; Surgical Antiseptic
• Interventions: Drug: Chloraprep

• Registration Number: NCT02017145
• Lead Sponsor: Sanford Health

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-12-16
• Study First Submitted QC: 2013-12-16
• Study First Posted: 2013-12-20
• Status Verified: 2014-02
• Study Start: 2014-02
• Last Update Submitted: 2014-02-17
• Last Update Posted: 2014-02-19
• Primary Completion: 2015-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 140

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
reapplication	Chloraprep	This group will have chloraprep reapplied following their lower extremity surgical procedure and prior to dressing application.

Primary Outcome Measures

Name	Time	Method
quantitative bacterial colonization	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
positive culture rate	14-21 days	Compare the overall positive culture rate between the two treatment groups

Secondary Outcome Measures

Name	Time	Method
bacterial strain identification	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

Trial Locations

Locations (1)

Sanford USD Medical Center; 🇺🇸 Sioux Falls, South Dakota, United States