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

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Sanford Health

Status and phase

Unknown
Phase 4

Conditions

Bacterial Colonization
Surgical Site Infection
Lower Extremity Surgery
Surgical Antiseptic

Treatments

Drug: Chloraprep

Study type

Interventional

Funder types

Other

Identifiers

NCT02017145
SH Chloraprep reapplication

Details and patient eligibility

About

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.

Enrollment

140 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

140 participants in 2 patient groups

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

Trial contacts and locations

1

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Central trial contact

Diane Hahn; Jeremy P Morgan, MS

Data sourced from clinicaltrials.gov

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