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

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02017145

Enrollment

140

Registered

2013-12-20

Start date

2014-02-28

Completion date

Unknown

Last updated

2014-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lower Extremity Surgery, Surgical Site Infection, Bacterial Colonization, Surgical Antiseptic

Keywords

infection, chloraprep, chlorhexidine, lower extremity surgery, antiseptic, bacterial colonization

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.

Interventions

DRUGChloraprep

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

United States

Contacts

Primary ContactJeremy P Morgan, MS

jeremy.morgan@sanfordhealth.org605-328-1398

Backup ContactDiane Hahn

diane.hahn@sanfordhealth.org605-328-1361

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026