NCT02017145

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.

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 16, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 20, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Last Updated

February 19, 2014

Status Verified

February 1, 2014

Enrollment Period

1 year

First QC Date

December 16, 2013

Last Update Submit

February 17, 2014

Conditions

Lower Extremity SurgerySurgical Site InfectionBacterial ColonizationSurgical Antiseptic

Keywords

infectionchloraprepchlorhexidinelower extremity surgeryantisepticbacterial colonization

Outcome Measures

Primary Outcomes (2)

  • quantitative bacterial colonization

    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

    Compare the overall positive culture rate between the two treatment groups

    14-21 days

Secondary Outcomes (1)

  • bacterial strain identification

    14-21 days

Study Arms (2)

no reapplication

NO INTERVENTION

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

reapplication

EXPERIMENTAL

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

Drug: Chloraprep

Interventions

ChloraprepDRUG
reapplication

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanford USD Medical Center

Sioux Falls, South Dakota, 57117, United States

RECRUITING

Related Publications (5)

  • Gould D. Causes, prevention and management of surgical site infection. Nurs Stand. 2012 Jul 25-31;26(47):47-56; quiz 58. doi: 10.7748/ns2012.07.26.47.47.c9226.

    PMID: 22913092BACKGROUND

  • Ostrander RV, Botte MJ, Brage ME. Efficacy of surgical preparation solutions in foot and ankle surgery. J Bone Joint Surg Am. 2005 May;87(5):980-5. doi: 10.2106/JBJS.D.01977.

    PMID: 15866959BACKGROUND

  • Darouiche RO, Wall MJ Jr, Itani KM, Otterson MF, Webb AL, Carrick MM, Miller HJ, Awad SS, Crosby CT, Mosier MC, Alsharif A, Berger DH. Chlorhexidine-Alcohol versus Povidone-Iodine for Surgical-Site Antisepsis. N Engl J Med. 2010 Jan 7;362(1):18-26. doi: 10.1056/NEJMoa0810988.

    PMID: 20054046BACKGROUND

  • Hibbard JS. Analyses comparing the antimicrobial activity and safety of current antiseptic agents: a review. J Infus Nurs. 2005 May-Jun;28(3):194-207. doi: 10.1097/00129804-200505000-00008.

    PMID: 15912075BACKGROUND

  • Hibbard JS, Mulberry GK, Brady AR. A clinical study comparing the skin antisepsis and safety of ChloraPrep, 70% isopropyl alcohol, and 2% aqueous chlorhexidine. J Infus Nurs. 2002 Jul-Aug;25(4):244-9. doi: 10.1097/00129804-200207000-00007.

    PMID: 12131506BACKGROUND

MeSH Terms

Conditions

Surgical Wound InfectionInfections

Condition Hierarchy (Ancestors)

Wound InfectionPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Kyle T Judd, MD

    Sanford Orthopedics and Sports Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeremy P Morgan, MS

CONTACT

605-328-1398jeremy.morgan@sanfordhealth.org

Diane Hahn

CONTACT

605-328-1361diane.hahn@sanfordhealth.org

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Employed Physician

Study Record Dates

First Submitted

December 16, 2013

First Posted

December 20, 2013

Study Start

February 1, 2014

Primary Completion

February 1, 2015

Last Updated

February 19, 2014

Record last verified: 2014-02

Locations

US(1)