Clinical trial NCT02017145: Study on the Reapplication of Chloraprep After Lower Extremity Surgery and Prior to Dressing Application
Official title: Role of Post-operative Re-application of Chloraprep® Following Lower Extremity Surgeries on Surgical Site Bacterial Colonization.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Lower Extremity Surgery
Surgical Site Infection
Bacterial Colonization
Surgical Antiseptic
Keywords: infection
chloraprep
chlorhexidine
lower extremity surgery
antiseptic
bacterial colonization
Lead sponsor: Sanford Health
Sponsor class: OTHER
First posted: 2013-12-20
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: quantitative bacterial colonization
timeFrame: 14-21 days
measure: positive culture rate
timeFrame: 14-21 days
Secondary outcomes:
measure: bacterial strain identification
timeFrame: 14-21 days
Other outcomes:
Locations:
city: Sioux Falls
country: United States
facility: Sanford USD Medical Center
state: South Dakota
Study officials:
affiliation: Sanford Orthopedics and Sports Medicine
name: Kyle T Judd, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.